Latest Industry News & Trends

Market Scope provides comprehensive coverage of the ophthalmic market. Our news stories are a combination of public and proprietary content ranging from coverage of international meetings, surgeon survey results and trends, analysis of company financial reports and public medical registries, press releases, and interviews with executives. Register today to receive free weekly email updates, our top data chart, surgeon poll results, and much more. Locked content can be accessed through a subscription to our ophthalmic industry newsletters.

Retina News

10/17/2025
BreakingDiagnosticFundusRetina
Optos Launches the Silverstone RGB Advanced Retinal Imaging System
Optos Launches the Silverstone RGB Advanced Retinal Imaging System

UK-based Optos announced Oct. 15 that it had launched its next-generation Silverstone RGB system for retinal imaging. The device is designed to allowclinicians to capture, visualize, and analyze pa...

10/17/2025
AIBreakingDealsDiagnosticRetina
EssilorLuxottica Acquires Screening Software Company RetinAI
EssilorLuxottica Acquires Screening Software Company RetinAI

Eyewear conglomerate EssilorLuxottica announced Oct. 15 that it would acquire Swiss company Ikerian, operating under the RetinAI brand. RetinAI develops tools to collect, process, and grade large-s...

10/17/2025
BreakingDiagnosticEuropeFundusRetina
OcuSciences’ OcuMet Beacon Retinal Imager Gains CE Marking
OcuSciences’ OcuMet Beacon Retinal Imager Gains CE Marking

OcuSciences, of Ann Arbor, Michigan, announced Oct. 15 that its OcuMet Beacon retinal imager had gained CE marking under the European Medical Device Regulation. The device gained US FDA 510(k) clea...

10/17/2025
BiosimilarsBreakingDealsRegulationRetina
US FDA Approves Celltrion’s Aflibercept Biosimilar Branded Eydenzelt
US FDA Approves Celltrion’s Aflibercept Biosimilar Branded Eydenzelt

South Korea’s Celltrion announced Oct. 9 that the US FDA had approved Eydenzelt, an aflibercept (Eylea) biosimilar. Eydenzelt (aflibercept-boav 40 mg/mL solution for injection) is indicated for wet...

10/17/2025
BreakingDealsDiagnosticOculomicsRetina
RetinalGenix Partners with Genotyping Lab on Disease Detection Through the Eye
RetinalGenix Partners with Genotyping Lab on Disease Detection Through the Eye

RetinalGenix Technologies announced Oct. 1 that it would collaborate with genotyping lab RGEN, of West Virginia, to advance the early detection of neurodegenerative, systemic, and retinal diseases....

10/17/2025
BreakingClinical TrialIndustryPharmaRetina
Ashvattha Names Bob Dempsey as Interim CEO
Ashvattha Names Bob Dempsey as Interim CEO

Ashvattha Therapeutics, of Redwood City, California, announced Oct. 14 that it had appointed Robert J. Dempsey as interim chief executive officer. The move follows the company’s release of positive...

10/10/2025
BreakingFundingRetinaStudy
Teresa Puthussery, PhD, OD, Named 2025 MacArthur Fellow
Teresa Puthussery, PhD, OD, Named 2025 MacArthur Fellow

Teresa Puthussery, PhD, a neurobiologist and optometrist, has been named one of the 22 MacArthur Fellows for 2025. The MacArthur Foundation, based in Chicago, Illinois, annually selects fellows who...

10/10/2025
BreakingClinical TrialPharmaRegulationRetina
Oculis Accelerates Privosegtor Toward Pivotal Trials in Neuro-ophthalmology
Oculis Accelerates Privosegtor Toward Pivotal Trials in Neuro-ophthalmology

Swiss company Oculis announced Oct. 6 that it will advance Privosegtor into a pivotal program for two indications in neuro-ophthalmology following a positive meeting with the US FDA. Privosegtor is...

10/10/2025
BreakingChinaPharmaRegulationRetina
Regulators in China Accept BLA for DME Candidate from Santen, RemeGen
Regulators in China Accept BLA for DME Candidate from Santen, RemeGen

Japan’s Santen Pharmaceutical and partner RemeGen announced Sept. 30 that China’s Center for Drug Evaluation had accepted the biologic license application (BLA) for retinal treatment candidate RC28...

10/10/2025
BreakingClinical TrialGene TherapyRegulationRetina
US FDA Gives Green Light to Phase I/II Trial of Complement’s GA Gene Therapy Candidate
US FDA Gives Green Light to Phase I/II Trial of Complement’s GA Gene Therapy Candidate

Complement Therapeutics announced Oct. 8 that the US FDA had signed off on its investigational new drug (IND) application, allowing the company to proceed with a Phase I/II trial of CTx001, a gene ...

10/3/2025
BreakingPharmaRegulationRetina
Outlook Meets with US FDA, Plans to Resubmit BLA for Lytenava This Year
Outlook Meets with US FDA, Plans to Resubmit BLA for Lytenava This Year

Outlook Therapeutics reported Sept. 29 that it had met with the US FDA regarding its latest rejection of the company’s biologics license application (BLA) for Lytenava, an ophthalmic formulation of...

10/3/2025
BreakingDealsDry EyeEuropeGlaucomaIndiaRetina
Visufarma Becomes Part of India’s Lupin Limited
Visufarma Becomes Part of India’s Lupin Limited

Visufarma BV, of the Netherlands, will become part of India-based Lupin Limited following Visufarma’s acquisition by a Lupin subsidiary. Visufarma has been owned by GHO Capital Partners, of London,...

9/26/2025
BreakingPharmaRegulationRetina
US FDA Accepts Idebenone NDA for Priority Review, Sets PDUFA Date of Feb. 28, 2026
US FDA Accepts Idebenone NDA for Priority Review, Sets PDUFA Date of Feb. 28, 2026

Chiesi announced Sept. 22 that the US FDA had accepted its new drug application (NDA) for oral idebenone to treat Leber hereditary optic neuropathy (LHON). Regulators set a Prescription Drug User F...

9/26/2025
BiosimilarsBreakingRegulationRetina
Regulators in Japan Approve Aflibercept (Eylea) Biosimilar from Alvotech and Fuji
Regulators in Japan Approve Aflibercept (Eylea) Biosimilar from Alvotech and Fuji

Iceland’s Alvotech announced Sept. 19 that its commercialization partner in Japan, Fuji Pharma, has received marketing approval for AVT06, a biosimilar to Eylea (aflibercept), from the Japanese Min...

9/22/2025
MeetingNewsletterRetinaSpendingSurgical
Alcon and BVI Launch New Vitrectomy Systems at Euretina Congress in Paris
Alcon and BVI Launch New Vitrectomy Systems at Euretina Congress in Paris

Equipment manufacturers launched new vitrectomy systems or instruments at the 2025 Euretina congress, held Sept. 4-7 at the Palais des Congrès in Paris. They had a large audience. Euretina set an a...

9/26/2025
BreakingFundingGene TherapyMyopiaRetinaStudy
NEI Awards U. of Houston Researchers $3.6 Million to Investigate Vision-Critical Gene
NEI Awards U. of Houston Researchers $3.6 Million to Investigate Vision-Critical Gene

A research team at the University of Houston was awarded more than $3.6 million from the National Eye Institute to investigate a gene that causes blinding retinal diseases when mutated. When workin...

9/26/2025
BreakingGene TherapyRegulationRetina
US FDA Grants Fast Track Status to Sanofi’s Wet AMD Gene Therapy Candidate
US FDA Grants Fast Track Status to Sanofi’s Wet AMD Gene Therapy Candidate

France’s Sanofi announced Sept. 11 that the US FDA had granted fast track designation to SAR402663, a one-time IVT gene therapy candidate for wet age-related macular degeneration. SAR402663 deliver...

9/22/2025
GlaucomaIOLNewsletterRefractiveRetina
Ophthalmic Company Revenue Down 1.9 Percent in Q2-2025 as Multiple Firms Report Declines
Ophthalmic Company Revenue Down 1.9 Percent in Q2-2025 as Multiple Firms Report Declines

Ophthalmic manufacturer revenue in Q2-2025 totaled $11.7 billion. Revenue decreased 1.9 percent from the same quarter in 2024 and increased 6.3 percent from Q1-2025. The total includes Market Scope...

9/22/2025
CataractGlaucomaIOLNewsletterRefractiveRetinaSurgical
Ophthalmologists Report 2.2 Percent Increase in Q2-2025 Procedure Volume
Ophthalmologists Report 2.2 Percent Increase in Q2-2025 Procedure Volume

US ophthalmologists reported that ophthalmic procedures increased 2.2 percent in Q2-2025 compared with the same quarter in 2024, according to Market Scope’s latest survey. Year-over-year performanc...

9/22/2025
NewsletterPharmaRegulationRetina
Annexon Aims to Make Difference in GA by Focusing on Neuroprotection
Annexon Aims to Make Difference in GA by Focusing on Neuroprotection

Excitement is growing around vonaprument (previously called ANX007), the drug that Annexon Biosciences is developing to treat geographic atrophy (GA). The international Phase III trial of the poten...

9/22/2025
NewsletterRegulationRetina
Regulatory Panel in Japan Recommends Izervay for Approval in GA
Regulatory Panel in Japan Recommends Izervay for Approval in GA

A Japanese panel has recommended approval for Astellas Pharma’s avacincaptad pegol (known in the US as Izervay) to slow the progression of geographic atrophy (GA), according to a Pharma Japan repor...

9/22/2025
AICell TherapyCornealDealsDigitalFundingGene TherapyGlaucomaNewsletterRetinaSurgicalThyroid Eye Disease
Kriya Leads Latest Ophthalmic Fundraising with $320 Million in Series D
Kriya Leads Latest Ophthalmic Fundraising with $320 Million in Series D

Kriya, of Durham, North Carolina, led recent ophthalmic fundraising efforts with a $320 million Series D round to fund its pipeline of gene therapy candidates. Financing announced in the past four ...

9/22/2025
NewsletterRegulationRetina
US FDA Again Rejects Outlook’s Lytenava for Wet AMD, Citing Lack of Efficacy Evidence
US FDA Again Rejects Outlook’s Lytenava for Wet AMD, Citing Lack of Efficacy Evidence

Outlook Therapeutics reported Aug. 28 that the US FDA had issued a complete response letter rejecting the company’s resubmitted biologics license application (BLA) for Lytenava, an ophthalmic formu...

9/22/2025
CornealMyopiaNewsletterRetina
PDUFA Dates for Ophthalmic Drug Candidates, September 2025
PDUFA Dates for Ophthalmic Drug Candidates, September 2025

The US FDA has scheduled the following Prescription Drug User Fee Act (PDUFA) target action dates for ophthalmic drug, drug/device, and biologic candidates.

9/22/2025
BiosimilarsDealsNewsletterRetina
Sandoz’ Deal with Regeneron Will Bring Enzeevu to Market in US by Q4-2026
Sandoz’ Deal with Regeneron Will Bring Enzeevu to Market in US by Q4-2026

Swiss drugmaker Sandoz announced Sept. 9 that it had reached an agreement with Regeneron to resolve all patent disputes related to Sandoz’ FDA-approved Eylea (aflibercept) biosimilar, branded in th...

9/22/2025
Cell TherapyClinical TrialGlaucomaNewsletterRefractiveRetina
Clinical Trial Updates for Ophthalmic Candidates, September 2025
Clinical Trial Updates for Ophthalmic Candidates, September 2025

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

11/8/2024
BreakingCataractEuropeGlaucomaIndiaIndustryMeetingNewsletterRefractiveRetina
2025-2027 Ophthalmic Meetings Calendar
2025-2027 Ophthalmic Meetings Calendar

Market Scope regularly updates its list of ophthalmic meetings to keep the information current. Please contact us at matthewdouty@market-scope.com if we do not have your meeting listed. Thank you.

9/22/2025
DeviceEuropeMeetingNewsletterRetina
Euretina Presentations Included Surprises on Vitreous Cutters, PBM Treatment
Euretina Presentations Included Surprises on Vitreous Cutters, PBM Treatment

Doctors who attend the annual Euretina congress often hear paper presentations similar to those at the American Society of Retina Specialists meeting, but sessions also provide important difference...

9/22/2025
Clinical TrialEuropeIndustryMeetingNewsletterRegulationRetina
Two European Retina Innovation Meetings, Two Audiences
Two European Retina Innovation Meetings, Two Audiences

Euretina once again scheduled its European Innovation Spotlight to go head-to-head with the Ophthalmology Futures Retina Forum. Both were held Sept. 3 in Paris, France. The two events seem similar ...

9/22/2025
AINewsletterRetinaStudy
Moran Celebrates Approval of AI Tech to Help Time Injections for Wet AMD
Moran Celebrates Approval of AI Tech to Help Time Injections for Wet AMD

The John A. Moran Eye Center is celebrating European regulatory approval of AI technology that assists ophthalmologists in timing intravitreal injections in wet age-related macular degeneration (AM...

9/22/2025
AICell TherapyCornealDiagnosticDigitalEmergingNewsletterRetinaUveitis
Emerging Companies Pursuing Ophthalmic Indications, September 2025
Emerging Companies Pursuing Ophthalmic Indications, September 2025

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

9/22/2025
NewsletterRefractiveRetina
Weekly Surgeon Poll, September 2025
Weekly Surgeon Poll, September 2025

9/22/2025
BiosimilarsClinical TrialCornealDealsDiagnosticDry EyeEuropeFundingGene TherapyGlaucomaIndustryNewsletterRefractiveRegulationRetinaSurgical
September 2025 Ophthalmic News Briefs
September 2025 Ophthalmic News Briefs

The UK-based National Institute for Health and Care Excellence (NICE) announced Sept. 11 that it had approved idebenone (marketed as Raxone by Chiesi Pharmaceuticals) for the treatment of Leber her...

9/19/2025
BreakingDealsGene TherapyRetina
Kwangdong Licenses Ocugen’s RP Gene Therapy Candidate for Korea
Kwangdong Licenses Ocugen’s RP Gene Therapy Candidate for Korea

Ocugen announced Sept. 15 that it had reached a licensing agreement with Kwangdong Pharmaceutical for exclusive Korean rights to OCU400—Ocugen’s modifier gene therapy candidate for retinitis pigmen...

9/19/2025
BiosimilarsBreakingDealsRetina
Sandoz’ Deal with Regeneron Will Bring Enzeevu to Market in US No Later than Q4-2026
Sandoz’ Deal with Regeneron Will Bring Enzeevu to Market in US No Later than Q4-2026

Swiss drugmaker Sandoz announced Sept. 9 that it had reached an agreement with Regeneron to resolve all patent disputes related to Sandoz’ FDA-approved Eylea (aflibercept) biosimilar, branded in th...

9/19/2025
BreakingRegulationRetina
UK’s NICE Approves First Treatment for Leber Hereditary Optic Neuropathy (LHON)
UK’s NICE Approves First Treatment for Leber Hereditary Optic Neuropathy (LHON)

The UK-based National Institute for Health and Care Excellence (NICE) announced Sept. 11 that it had approved idebenone (marketed as Raxone by Chiesi Pharmaceuticals) for the treatment of Leber her...

9/19/2025
BiosimilarsBreakingDealsEuropeRetina
Formycon, Klinge License Eylea Biosimilar to Horus for France, Other European Countries
Formycon, Klinge License Eylea Biosimilar to Horus for France, Other European Countries

German companies Formycon and Klinge Biopharma announced Sept. 17 that they had reached a deal with France-based Horus Pharma to license their Eylea (aflibercept) biosimilar for France and other se...

9/19/2025
BiosimilarsBreakingEuropeRegulationRetina
Alteogen Gains EU Approval for Eylea Biosimilar Eyluxvi
Alteogen Gains EU Approval for Eylea Biosimilar Eyluxvi

South Korea’s Alteogen announced Sept. 17 that the European Commission had granted marketing authorization for Eyluxvi (formerly ALT-L9), its biosimilar to Eylea (aflibercept 2 mg). The biosimilar ...

9/12/2025
BreakingCornealRetina
Xpanceo and Intra-Ker Unveil Corneal Implant that Projects Images onto Retina
Xpanceo and Intra-Ker Unveil Corneal Implant that Projects Images onto Retina

Xpanceo, of the United Arab Emirates, and Intra-Ker, of Italy, announced Sept. 3 successful proof of concept of their intracorneal implant, designed to restore vision in patients with corneal blind...

9/12/2025
BreakingEuropeRegulationRetina
Nanoscope’s MCO-010 Gains Five EMA Orphan Designations and US FDA RMAT Status
Nanoscope’s MCO-010 Gains Five EMA Orphan Designations and US FDA RMAT Status

Nanoscope Therapeutics announced Sept. 2 that the European Medicines Agency (EMA) had granted orphan designations to MCO-010 (sonpiretigene isteparvovec) across five categories of retinal dystrophi...

9/12/2025
BreakingGene TherapyIndustryRetina
4DMT Promotes Julie Clark, MD, to Chief Medical Officer
4DMT Promotes Julie Clark, MD, to Chief Medical Officer

4D Molecular Therapeutics announced Sept. 2 that it had promoted Julie Clark, MD, to chief medical officer. Clark joined 4DMT in July 2025 as senior vice president, clinical research and developmen...

9/5/2025
BreakingCataractEquipmentEuropeRetinaSurgical
BVI Launches Virtuoso Dual-Function Cataract/Vitrectomy System in Europe
BVI Launches Virtuoso Dual-Function Cataract/Vitrectomy System in Europe

BVI Medical announced Sept. 3 that it had unveiled its new Virtuoso dual-function cataract/vitrectomy surgical platform in Europe, expanding the company’s offerings beyond IOLs and consumables. BVI...

9/5/2025
BreakingEuropePharmaRegulationRetina
Roche Gains CE Marking for Port Delivery Platform, Branded Contivue in Europe
Roche Gains CE Marking for Port Delivery Platform, Branded Contivue in Europe

Swiss drugmaker Roche announced Sept. 4 that it had gained CE marking for its Port Delivery Platform, a refillable ranibizumab implant, which will be known as Contivue in Europe. The approval compr...

9/5/2025
BreakingDealsDiagnosticRetina
Former LumiThera Diagnostic Business Relaunches as OpZira After Alcon Deal
Former LumiThera Diagnostic Business Relaunches as OpZira After Alcon Deal

LumiThera’s former ophthalmic diagnostic business has been spun off and relaunched as OpZira, the new company announced Sept. 3. As part of Alcon’s acquisition of the Valeda Light Delivery System f...

9/5/2025
BreakingPharmaRegulationRetina
Regulatory Panel in Japan Recommends Izervay for Approval in GA
Regulatory Panel in Japan Recommends Izervay for Approval in GA

A Japanese panel has recommended approval for Astellas Pharma’s avacincaptad pegol (known in the US as Izervay) to slow the progression of geographic atrophy (GA), according to a Pharma Japan repor...

9/5/2025
BreakingFundingRetina
LambdaVision Secures NASA Award to Advance Manufacturing of Artificial Retina in Low-Earth Orbit
LambdaVision Secures NASA Award to Advance Manufacturing of Artificial Retina in Low-Earth Orbit

LambdaVision announced Sept. 4 that it had secured an award from the National Aeronautics and Space Administration (NASA) to further develop the low-Earth orbit manufacturing process for its artifi...

8/29/2025
BreakingPharmaRegulationRetina
US FDA Again Rejects Outlook’s Lytenava for Wet AMD, Citing Lack of Efficacy Evidence
US FDA Again Rejects Outlook’s Lytenava for Wet AMD, Citing Lack of Efficacy Evidence

Outlook Therapeutics reported Aug. 28 that the US FDA had issued a complete response letter rejecting the company’s resubmitted biologics license application (BLA) for Lytenava, an ophthalmic formu...

8/29/2025
BiosimilarsBreakingDiagnosticDry EyeLaserMyopiaRetinaRevenue
Quarterly Ophthalmic Revenue Roundup for Santen, Lumibird, Biogen, and Xbrane
Quarterly Ophthalmic Revenue Roundup for Santen, Lumibird, Biogen, and Xbrane

Japan’s Santen Pharmaceutical reported Aug. 7 that its revenue for the quarter ended June 30, 2025, the first quarter of its fiscal year, was ¥68.7 billion ($475.6 million, converted on June 30, 20...

8/29/2025
BreakingPharmaRegulationRetina
Manufacturer Inspection Report Delays Two Eylea HD Target Action Dates 
Manufacturer Inspection Report Delays Two Eylea HD Target Action Dates

Regeneron announced Aug. 20 that the US FDA had extended the target action dates to Q4-2025 for two Eylea HD (aflibercept 8 mg) submissions. Reports from a recent inspection of a third-party manufa...

8/29/2025
BreakingRegulationRetina
US FDA Grants Fast Track Status to Aldeyra’s ADX‑2191 (Methotrexate) for RP
US FDA Grants Fast Track Status to Aldeyra’s ADX‑2191 (Methotrexate) for RP

Aldeyra Therapeutics announced Aug. 19 that the US FDA had granted its fast track designation to ADX‑2191 (methotrexate intravitreal injection) for retinitis pigmentosa (RP). The candidate also has...

8/29/2025
BreakingGene TherapyRegulationRetina
US FDA Grants RMAT Status to VeonGen’s Gene Therapy Candidate in Stargardt
US FDA Grants RMAT Status to VeonGen’s Gene Therapy Candidate in Stargardt

Germany’s VeonGen Therapeutics announced Aug. 21 that the US FDA had granted regenerative medicine advanced therapy (RMAT) designation to VG801, its gene therapy candidate for Stargardt disease and...

8/22/2025
BiosimilarsBreakingEuropeRegulationRetina
Alvotech, Advanz Gain EU Approval for Eylea Biosimilar Under Brand Name Mynzepli
Alvotech, Advanz Gain EU Approval for Eylea Biosimilar Under Brand Name Mynzepli

Alvotech and partner Advanz Pharma announced Aug. 21 that the European Commission had granted marketing authorization for their Eylea (aflibercept 2 mg) biosimilar under the brand name Mynzepli. Th...

8/22/2025
BreakingCataractDealsDiagnosticIndustryPharmaPresbyopiaRetinaRevenueSurgical
Q2-2025 Ophthalmic Revenue Roundup for Alcon, Carl Zeiss Meditec, Opus, and Outlook
Q2-2025 Ophthalmic Revenue Roundup for Alcon, Carl Zeiss Meditec, Opus, and Outlook

Alcon reported Aug. 19 that its Q2-2025 net sales totaled $2.6 billion, a 4 percent increase (+3 percent cc) over $2.5 billion in Q2-2024. Surgical net sales for implantables, consumables, and equi...

8/20/2025
MeetingNewsletterRetinaSurgical
ASRS Meeting Returns Surgery to the Forefront of Discussion
ASRS Meeting Returns Surgery to the Forefront of Discussion

Guarav Shah, MD, program chair for the 2025 annual meeting of the American Society of Retina Specialists (ASRS), opened the conference with an important announcement. “We have to recalibrate what w...

8/22/2025
BreakingDealsPharmaRetina
Boehringer Ingelheim, Palatin to Collaborate on Melanocortin Agonist for Retina
Boehringer Ingelheim, Palatin to Collaborate on Melanocortin Agonist for Retina

Boehringer Ingelheim and Palatin Technologies will collaborate to develop a therapy for retinal diseases in a deal worth up to $320 million for Palatin, the companies announced Aug. 18. Palatin’s p...

8/22/2025
BreakingChinaDealsPharmaRetina
Santen Licenses RemeGen’s Retinal Candidate for Greater China, Asian Countries
Santen Licenses RemeGen’s Retinal Candidate for Greater China, Asian Countries

RemeGen announced Aug. 18 that Santen China, a subsidiary of Japan’s Santen Pharmaceutical, had licensed retinal treatment candidate RC28-E for Greater China and certain other Asian countries. Reme...

8/22/2025
BreakingClinical TrialGene TherapyRegulationRetina
US FDA Gives Green Light to Phase I/II Trial of Opus’ BEST1 Gene Therapy Candidate
US FDA Gives Green Light to Phase I/II Trial of Opus’ BEST1 Gene Therapy Candidate

Opus Genetics announced Aug. 18 that the US FDA had cleared its investigational new drug (IND) application for OPGx-BEST1, a gene therapy candidate targeting bestrophin-1 (BEST1)-related inherited ...

8/20/2025
NewsletterRegulationRetina
Nanoscope Targets Sight Restoration Instead of Blindness Prevention
Nanoscope Targets Sight Restoration Instead of Blindness Prevention

Ashish Patel, PhD, MBA, calls blind people “the most underserved population” in ophthalmology. Patel, senior vice president for sales and marketing at Nanoscope Therapeutics, said other drug compan...

8/20/2025
BiosimilarsNewsletterRegulationRetina
US CMS Issues J-Code for Encelto, Q-Code for Yesafili for Billing Payers
US CMS Issues J-Code for Encelto, Q-Code for Yesafili for Billing Payers

The US Centers for Medicare and Medicaid Services (CMS) issued a J-code for Neurotech’s Encelto and a Q-code for Biocon Biologics’ Yesafili during Q2-2025. The codes take effect Oct. 1, 2025. In ad...

8/20/2025
CataractNewsletterRegulationRetinaSurgical
CMS Proposes Lower Physician Payments in 2026, Higher HOPD and ASC Fees
CMS Proposes Lower Physician Payments  in 2026, Higher HOPD and ASC Fees

US ophthalmologists are gaining some clarity on what their reimbursement for treating Medicare patients may look like in 2026. Documents published by the Centers for Medicare and Medicaid Services ...

8/20/2025
CataractInstrumentsNewsletterRetinaSurgical
Sustainability Movement Gains Traction, Impacts Growth in Reusable Instruments
Sustainability Movement Gains Traction, Impacts Growth in Reusable Instruments

In recent years, the world’s largest ophthalmic surgical societies have expressed increasing concern over the environmental impact of operating room waste generated annually by the world’s 50 milli...

8/20/2025
MeetingNewsletterRetinaSurgical
Methotrexate Has ‘Avastin Moment’ at ASRS Meeting
Methotrexate Has ‘Avastin Moment’ at ASRS Meeting

Christopher Riemann, MD (US), was stunned when he initially saw the results from the first preplanned interim safety analysis of the Phase II FIXER trial on preventing proliferative vitreoretinopat...

8/20/2025
MeetingNewsletterRetinaSurgical
ASRS Sessions Highlight Value of Amniotic Membrane in Retinal Surgery
ASRS Sessions Highlight Value of Amniotic Membrane in Retinal Surgery

The use of human amniotic membrane in vitreoretinal surgery was discussed in several sessions at the American Society of Retina Specialists’ 2025 meeting. Presentations suggest that this material w...

8/20/2025
MeetingNewsletterRetinaSurgical
Speakers at ASRS Meeting Lament Dwindling Access to Operating Room
Speakers at ASRS Meeting Lament Dwindling Access  to Operating Room

Access to the operating room (OR) was a hot topic at the 2025 meeting of the American Society of Retina Specialists. The majority of retina surgeons said access to the OR was an issue. Forty-nine p...

8/20/2025
Clinical TrialDealsMeetingNewsletterRetina
Cencora Steps into Major Role at ASRS Meeting Following Acquisition
Cencora Steps into Major Role at ASRS Meeting Following Acquisition

The 2025 ASRS scientific meeting was a first for Cencora as an operator of clinical trials, but not for its subsidiary Retina Consultants of America (RCA). Cencora (formerly AmerisourceBergen), bet...

8/20/2025
FundingGene TherapyNewsletterRetina
Ocugen Leads Latest Ophthalmic Fundraising with $20 Million Offering
Ocugen Leads Latest Ophthalmic Fundraising with $20 Million Offering

Ocugen led recent ophthalmic fundraising efforts with a $20 million registered direct offering to advance its clinical gene therapy pipeline in retina. Financing announced in the past four weeks to...

8/20/2025
DealsFundingNewsletterRetina
Boehringer Ingelheim and Re-Vana Sign Potential $1 Billion Collaboration Deal
Boehringer Ingelheim and Re-Vana Sign Potential $1 Billion Collaboration Deal

Boehringer Ingelheim and Re-Vana Therapeutics will collaborate to develop extended-release therapies for eye diseases in a deal worth potentially more than $1 billion for Re-Vana, the companies ann...

8/20/2025
AIDealsDiagnosticDigitalNewsletterRetina
Topcon Acquires Retinal Screening Platform to Improve Bidirectional Referrals
Topcon Acquires Retinal Screening  Platform to Improve Bidirectional Referrals

Topcon Healthcare reported July 31 that it had acquired Intelligent Retinal Imaging Systems (IRIS), a Pensacola, Florida-based developer of cloud-based retinal screening technology. No financial de...

8/20/2025
Clinical TrialCornealDry EyeGene TherapyGlaucomaNewsletterRetina
Clinical Trial Updates for Ophthalmic Candidates, August 2025
Clinical Trial Updates for Ophthalmic Candidates, August 2025

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

8/20/2025
DiagnosticDry EyeEmergingGene TherapyGlaucomaNewsletterRetina
Emerging Companies Pursuing Ophthalmic Indications, August 2025
Emerging Companies Pursuing Ophthalmic Indications, August 2025

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

8/20/2025
BiosimilarsClinical TrialDealsDry EyeEuropeGene TherapyGlaucomaIndustryInstrumentsLaserNewsletterRegulationRetinaSurgical
August 2025 Ophthalmic News Briefs
August 2025 Ophthalmic News Briefs

Glaukos announced during its earnings call on July 30 that it had acquired Mobius Therapeutics, of St. Louis, Missouri, whose lead compound, Mitosol, is the only FDA approved ophthalmic formulation...

8/15/2025
BreakingCataractDry EyeGlaucomaLaserOcular CancerPharmaRetinaRevenueSurgical
Q2-2025 Ophthalmic Revenue Roundup for Tarsus, Immunocore, Harrow, ANI, Sight Sciences, and Iridex
Q2-2025 Ophthalmic Revenue Roundup for Tarsus, Immunocore, Harrow, ANI, Sight Sciences, and Iridex

Tarsus Pharmaceuticals, of Irvine, California, reported Aug. 6 that its Q2-2025 Xdemvy net product revenue was $102.7 million, a 152 percent increase over $40.8 million in Q2-2024. The company said...

8/15/2025
BreakingEuropeRegulationRetina
EMA Selects Annexon’s GA Candidate for Regulatory Pilot Program
EMA Selects Annexon’s GA Candidate for Regulatory Pilot Program

Annexon announced Aug. 7 that vonaprument (formerly ANX007), the company’s treatment candidate for geographic atrophy, was among the programs selected by the European Medicines Agency (EMA) to part...

8/15/2025
AIBreakingDiagnosticDigitalPharmaRetina
Moran Celebrates Approval of AI Tech to Help Time Injections for Wet AMD
Moran Celebrates Approval of AI Tech to Help Time Injections for Wet AMD

The John A. Moran Eye Center is celebrating European regulatory approval of AI technology that assists ophthalmologists in timing intravitreal injections in wet age-related macular degeneration (AM...

8/15/2025
BreakingRetinaSurgical
First Commercial Procedure Performed with Encelto, Only FDA-Approved Treatment for MacTel
First Commercial Procedure Performed with Encelto, Only FDA-Approved Treatment for MacTel

Neurotech Pharmaceuticals, of Cumberland, Rhode Island, announced Aug. 11 the first commercial surgical procedure for Encelto, the only US FDA-approved treatment for macular telangiectasia (MacTel)...

8/15/2025
BreakingGene TherapyRegulationRetina
US FDA Grants Fast Track Status to AAVantgarde’s Stargardt Candidate
US FDA Grants Fast Track Status to AAVantgarde’s Stargardt Candidate

Italy’s AAVantgarde Bio announced Aug. 12 that the US FDA had granted fast track status to AAVB-039, its gene therapy candidate for Stargardt disease. AAVB-039 aims to address the underlying geneti...

8/8/2025
BiosimilarsBreakingDry EyeGlaucomaIOLPresbyopiaRetinaRevenueSurgicalThyroid Eye Disease
Q2-2025 Ophthalmic Revenue Roundup for Regeneron, Amgen, AbbVie, Hoya, and Ocular Therapeutix
Q2-2025 Ophthalmic Revenue Roundup for Regeneron, Amgen, AbbVie, Hoya, and Ocular Therapeutix

Regeneron, of Tarrytown, New York, reported Aug. 1 that its Q2-2025 US revenue for Eylea HD and Eylea 2 mg was $1.15 billion, a 25 percent decrease from $1.53 billion in Q2-2024. Eylea HD accounted...

8/8/2025
BiosimilarsBreakingRegulationRetina
​US CMS Issues J-Code for Encelto, Q-Code for Yesafili for Billing Payers
​US CMS Issues J-Code for Encelto, Q-Code for Yesafili for Billing Payers

The US Centers for Medicare and Medicaid Services (CMS) issued a J-code for Neurotech’s Encelto and a Q-code for Biocon Biologics’ Yesafili during Q2-2025. The codes take effect Oct. 1, 2025. In ad...

8/8/2025
BreakingClinical TrialDealsGene TherapyRetina
Regenxbio Plans Pivotal Program for DR Gene Therapy, Amends Deal with AbbVie
Regenxbio Plans Pivotal Program for DR Gene Therapy, Amends Deal with AbbVie

Regenxbio announced Aug. 7 that it was planning a pivotal program for its suprachoroidal gene therapy candidate in diabetic retinopathy (DR)—along with a corresponding amendment to its collaboratio...

8/8/2025
AIBreakingDealsDiagnosticDigitalOculomicsRetina
Topcon Healthcare Acquires Retinal Screening Platform to Improve Bidirectional Referrals
Topcon Healthcare Acquires Retinal Screening Platform to Improve Bidirectional Referrals

Topcon Healthcare reported July 31 that it had acquiredIntelligent Retinal Imaging Systems (IRIS), a Pensacola, Florida-based developer of cloud-based retinal screening technology. No financial det...

8/8/2025
BreakingEuropeRegulationRetina
EMA Grants Orphan Designation to Aldeyra’s Methotrexate Injection for RP
EMA Grants Orphan Designation to Aldeyra’s Methotrexate Injection for RP

Aldeyra Therapeutics announced July 24 that the European Medicines Agency (EMA) had granted orphan designation for ADX-2191 (methotrexate intravitreal injection) for inherited retinal dystrophies o...

8/8/2025
AIBreakingDiagnosticIndustryRetina
Aeye Health Appoints Pamela F. Gallin, MD, as Chief Medical Officer
Aeye Health Appoints Pamela F. Gallin, MD, as Chief Medical Officer

Aeye Health announced July 31 that it had appointed Pamela F. Gallin, MD, as its chief medical officer. Gallin is a clinical professor of ophthalmology in pediatrics at the Morgan Stanley Children’...

8/1/2025
BreakingCataractCornealGlaucomaIOLRetinaRevenueSurgical
Q2-2025 Ophthalmic Revenue Roundup for Roche, Bausch + Lomb, Apellis, Glaukos, and Astellas
Q2-2025 Ophthalmic Revenue Roundup for Roche, Bausch + Lomb, Apellis, Glaukos, and Astellas

Swiss company Roche reported July 24 that Vabysmo sales for Q2-2025 were CHF 1.05 billion ($1.3 billion, converted June 30, 2025), a 19 percent increase over CHF 947 million in Q2-2024. Roche said ...

8/1/2025
BreakingCataractGlaucomaRegulationRetinaSurgical
CMS Proposes Lower Physician Payments in 2026, Higher HOPD and ASC Fees
CMS Proposes Lower Physician Payments in 2026, Higher HOPD and ASC Fees

US ophthalmologists are gaining some clarity on what their reimbursement for treating Medicare patients may look like in 2026. Documents published by the Centers for Medicare and Medicaid Services ...

8/1/2025
BreakingDealsPharmaRetina
Boehringer Ingelheim and Re-Vana Sign Potential $1 Billion Collaboration Deal
Boehringer Ingelheim and Re-Vana Sign Potential $1 Billion Collaboration Deal

Boehringer Ingelheim and Re-Vana Therapeutics will collaborate to develop extended-release therapies for eye diseases in a deal worth potentially more than $1 billion for Re-Vana, the companies ann...

8/1/2025
BiosimilarsBreakingEuropeRegulationRetina
Aflibercept Biosimilar Candidate from Alteogen Gains Positive CHMP Opinion
Aflibercept Biosimilar Candidate from Alteogen Gains Positive CHMP Opinion

South Korea’s Alteogen announced July 28 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended approval for Eyluxvi (ALT-L9), its proposed biosi...

8/1/2025
BreakingClinical TrialPharmaRetina
Exonate Plans Phase IIb Trial of Retinal Eye Drop Candidate in NPDR
Exonate Plans Phase IIb Trial of Retinal Eye Drop Candidate in NPDR

British company Exonate announced July 29 that it planned a Phase IIb clinical trial for lead compound EXN407, an eye drop candidate targeting retinal vascular diseases, in patients with non-prolif...

8/1/2025
BreakingIndustryRetina
Unity Board Dissolves Company, Ending Research Targeting Senescent Cells
Unity Board Dissolves Company, Ending Research Targeting Senescent Cells

Unity Biotechnology’s board agreed on June 27 to dissolve the South San Francisco, California, company after evaluating strategic alternatives. The Nasdaq delisted Unity’s stock on July 9. Both mov...

7/25/2025
BiosimilarsBreakingDealsRetina
Bioeq Licenses Lucentis Biosimilar to Bio Usawa for Sub-Saharan Africa
Bioeq Licenses Lucentis Biosimilar to Bio Usawa for Sub-Saharan Africa

Swiss company Bioeq announced July 1 that it had licensed its Lucentis (ranibizumab) biosimilar to African biotech company Bio Usawa for marketing in sub-Saharan Africa under the brand name BioUcen...

7/25/2025
BreakingRegulationRetinaUveitis
Regulators in Canada Approve Xipere for Uveitic Macular Edema
Regulators in Canada Approve Xipere for Uveitic Macular Edema

Clearside Biomedical announced July 23 that Health Canada had approved Xipere (triamcinolone acetonide injectable suspension) for suprachoroidal use in uveitic macular edema. Bausch + Lomb has lice...

7/25/2025
BreakingPharmaRetinaRevenue
Novartis Reports Q2-2025 Lucentis Revenue of $173 Million
Novartis Reports Q2-2025 Lucentis Revenue of $173 Million

Novartis reported July 17 that its Q2-2025 Lucentis revenue outside the US was $173 million, a 37 percent decline (-39 percent cc) from $275 million in Q2-2024. The Swiss company said sales decline...

7/25/2025
BreakingDealsGene TherapyRetina
Beacon Licenses Abeona’s AAV204 Capsid for Select Ophthalmic Indications
Beacon Licenses Abeona’s AAV204 Capsid for Select Ophthalmic Indications

Beacon Therapeutics has exercised its option to license Abeona Therapeutics’ AAV204 capsid for potential gene therapies for select ophthalmic indications, the companies announced July 1. Under the ...

7/25/2025
BreakingGene TherapyRegulationRetina
US FDA Grants Fast Track Status to Sanofi’s GA Gene Therapy Candidate
US FDA Grants Fast Track Status to Sanofi’s GA Gene Therapy Candidate

France’s Sanofi announced July 16 that the US FDA had granted fast track designation to SAR446597, its gene therapy candidate for geographic atrophy (GA). SAR446597, designed for one-time intravitr...

7/25/2025
BreakingIndustryPharmaRetina
Outlook Therapeutics Appoints Bob Jahr as CEO
Outlook Therapeutics Appoints Bob Jahr as CEO

Outlook Therapeutics announced July 1 that it had appointed Bob Jahr as chief executive officer. Jahr will also take a seat on Outlook’s board, the company said. Lawrence A. Kenyon, who had served ...

7/22/2025
AcquisitionsDealsNewsletterRetina
Alcon to Acquire LumiThera and Its Photobiomodulation Device for Dry AMD
Alcon to Acquire LumiThera and Its Photobiomodulation Device for Dry AMD

Alcon announced July 7 that it intended to acquire LumiThera and its photobiomodulation (PBM) device that targets early and intermediate dry age-related macular degeneration (AMD). No financial det...

7/22/2025
DealsNewsletterRetina
Harrow Secures US Rights to Retinal Biosimilars Byooviz and Opuviz
Harrow Secures US Rights to Retinal Biosimilars Byooviz and Opuviz

Harrow announced July 17 that it had secured exclusive US commercial rights to Samsung Bioepis’ FDA-approved ophthalmology biosimilars—Byooviz (ranibizumab-nuna) and Opuviz (aflibercept-yszy). No f...

7/22/2025
AICataractFundingGene TherapyGlaucomaNewsletterPharmaRetinaSurgical
ForSight Leads Latest Ophthalmic Fundraising with $125 Million in Series B
ForSight Leads Latest Ophthalmic Fundraising with $125 Million in Series B

Israel’s ForSight Robotics led recent ophthalmic fundraising efforts with $125 million in Series B funding as it prepares its robotic cataract surgery system for human trials. Financing announced i...

7/22/2025
Clinical TrialNewsletterRegulationRetina
Retina Researchers Urge J&J to File for Approval of XLRP Gene Therapy Despite Failed Trial
Retina Researchers Urge J&J to File for Approval of XLRP Gene Therapy Despite Failed Trial

Investigators in the Phase III LUMEOS trial, with backing from the Foundation Fighting Blindness, issued a statement June 6 exhorting Johnson & Johnson to file for US FDA approval of bota-vec, a ge...

7/22/2025
CornealDiagnosticDry EyeMeetingNewsletterPharmaRetinaSurgical
EyeDura Wins Two Octane Awards for Sustained-Release Eye Drop Platform
EyeDura Wins Two Octane Awards  for Sustained-Release Eye Drop Platform

EyeDura Therapeutics earned the judges’ top award during Octane’s capital and growth company presentations, which spotlighted early-stage, high-potential ophthalmic ventures. The company was a favo...

7/22/2025
DiagnosticMeetingNewsletterRetina
Baruch Kuppermann, MD, PhD, Receives 2025 Roger Steinert, MD, Legacy Award
Baruch Kuppermann, MD, PhD, Receives  2025 Roger Steinert, MD, Legacy Award

Baruch Kuppermann, MD, PhD, was honored at the Octane meeting as the recipient of the 2025 Roger Steinert, MD, Legacy Award, which recognizes significant leadership, innovation, and enduring contri...

7/22/2025
IndustryNewsletterRetina
Clearside Explores Strategic Alternatives, Transitions Workforce
Clearside Explores Strategic Alternatives, Transitions Workforce

Clearside Biomedical reported July 17 that it was exploring strategic alternatives to continue advancing its suprachoroidal space delivery platform and ophthalmic pipeline, while transitioning all ...

7/22/2025
Cell TherapyClinical TrialNewsletterRetina
OpRegen’s Phase I/IIa Trial in GA Shows Mean Improvement in VA Through 36 Months
OpRegen’s Phase I/IIa Trial in GA Shows Mean Improvement in VA Through 36 Months

Lineage Cell Therapeutics reported on June 23 that patients with geographic atrophy who were treated with OpRegen cell therapy in a Phase I/IIa clinical study showed mean improvement in visual acui...

7/22/2025
Cell TherapyClinical TrialCornealDry EyeGene TherapyGlaucomaNewsletterRetina
Clinical Trial Updates for Ophthalmic Candidates, July 2025
Clinical Trial Updates for Ophthalmic Candidates, July 2025

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

7/22/2025
AICell TherapyChinaDiagnosticEmergingGene TherapyNewsletterRetina
Emerging Companies Pursuing Ophthalmic Indications, July 2025
Emerging Companies Pursuing Ophthalmic Indications, July 2025

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

7/22/2025
Clinical TrialLaserNewsletterRetina
Iridex Reports Start of UK Trial Using MicroPulse with Anti-VEGF Injections in DME
Iridex Reports Start of UK Trial Using MicroPulse with Anti-VEGF Injections in DME

Iridex reported June 24 that an independent, investigator-led UK study evaluating MicroPulse technology as an adjunct to anti-VEGF therapy in diabetic macular edema (DME) had enrolled its first pat...

7/22/2025
BiosimilarsCornealDry EyeMyopiaNewsletterPresbyopiaRegulationRetina
PDUFA Dates for Ophthalmic Drug Candidates, July 2025
PDUFA Dates for Ophthalmic Drug Candidates, July 2025

The US FDA has scheduled the following Prescription Drug User Fee Act (PDUFA) target action dates for ophthalmic drug, drug/device, and biologic candidates.

7/22/2025
BiosimilarsCataractCell TherapyChinaClinical TrialDealsDiagnosticDry EyeEuropeFundingFundusGene TherapyGlaucomaNewsletterPharmaPresbyopiaRegulationRetinaSurgical
July 2025 Ophthalmic News Briefs
July 2025 Ophthalmic News Briefs

Hoya Vision Care announced June 2 that it had acquired Centennial Optical, a Canadian distributor of ophthalmic frames, eyeglass lenses, sunglasses, lab supplies, and optical accessories. Financial...

7/18/2025
BiosimilarsBreakingDealsRetina
Harrow Secures US Rights to Retinal Biosimilars Byooviz and Opuviz
Harrow Secures US Rights to Retinal Biosimilars Byooviz and Opuviz

Harrow announced July 17 that it had secured exclusive US commercial rights to Samsung Bioepis’ FDA-approved ophthalmology biosimilars—Byooviz (ranibizumab-nuna) and Opuviz (aflibercept-yszy). No f...

7/18/2025
BreakingIndustryPharmaRetina
Clearside Explores Strategic Alternatives, Transitions Workforce
Clearside Explores Strategic Alternatives, Transitions Workforce

Clearside Biomedical reported July 17 that it was exploring strategic alternatives to continue advancing its suprachoroidal space delivery platform and ophthalmic pipeline, while transitioning all ...

7/18/2025
BreakingGene TherapyRegulationRetina
Nanoscope Initiates Rolling BLA Submission for Optogenetic RP Candidate
Nanoscope Initiates Rolling BLA Submission for Optogenetic RP Candidate

Nanoscope Therapeutics announced July 14 that it had initiated a rolling biologics license application (BLA) submission to the US FDA for MCO-010, an ambient-light-activatable optogenetic monothera...

7/18/2025
BreakingClinical TrialGene TherapyRegulationRetina
US FDA Gives Green Light to Trial of AAVantgarde’s Stargardt Gene Therapy Candidate
US FDA Gives Green Light to Trial of AAVantgarde’s Stargardt Gene Therapy Candidate

Italy’s AAVantgarde Bio announced July 15 that the US FDA had cleared the investigational new drug (IND) application for AAVB-039, its gene therapy candidate for Stargardt disease. The company said...

7/11/2025
BreakingDealsDeviceRetina
Alcon to Acquire LumiThera and Its Photobiomodulation Device for Dry AMD
Alcon to Acquire LumiThera and Its Photobiomodulation Device for Dry AMD

Alcon announced July 7 that it intended to acquire LumiThera and its photobiomodulation (PBM) device that targets early and intermediate dry age-related macular degeneration (AMD). No financial det...

7/11/2025
BreakingEuropeRegulationRetina
EU Regulators Approve Extended Six-Month Treatment Interval for Eylea 8 mg
EU Regulators Approve Extended Six-Month Treatment Interval for Eylea 8 mg

German drugmaker Bayer announced June 27 that European regulators had granted a label extension for Eylea (aflibercept) 8 mg with extended treatment intervals of up to six months in wet age-related...

7/11/2025
BreakingCataractEquipmentRegulationRetinaSurgical
Alcon Unity VCS Dual-Function System Gains Approval in Canada
Alcon Unity VCS Dual-Function System Gains Approval in Canada

Alcon announced July 8 that its dual-function Unity Vitreoretinal Cataract System (VCS) had gained market approval from Health Canada. Commercial launch in Canada is expected in early 2026, the com...

7/11/2025
BiosimilarsBreakingRegulationRetina
Biocon Gains Approval in Canada for Yesafili, a Biosimilar to Eylea
Biocon Gains Approval in Canada for Yesafili, a Biosimilar to Eylea

India’s Biocon Biologics announced June 27 that Health Canada regulators had approved Yesafili, an aflibercept (Eylea) biosimilar, for wet age-related macular degeneration, macular edema secondary ...

7/11/2025
BiosimilarsBreakingEuropeRegulationRetina
Aflibercept Biosimilar Candidate from Alvotech Gains Positive CHMP Opinion
Aflibercept Biosimilar Candidate from Alvotech Gains Positive CHMP Opinion

Alvotech and partner Advanz Pharma announced June 23 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended approval for AVT06, Alvotech’s propos...

7/3/2025
BreakingClinical TrialLaserRetina
Iridex Reports Start of UK Trial Using MicroPulse with Anti-VEGF Injections in DME
Iridex Reports Start of UK Trial Using MicroPulse with Anti-VEGF Injections in DME

Iridex reported June 24 that an independent, investigator-led UK study evaluating MicroPulse technology as an adjunct to anti-VEGF therapy in diabetic macular edema (DME) had enrolled its first pat...

7/3/2025
BreakingClinical TrialRetina
OpRegen’s Phase I/IIa Trial in GA Shows Mean Improvement in VA Through 36 Months
OpRegen’s Phase I/IIa Trial in GA Shows Mean Improvement in VA Through 36 Months

Lineage Cell Therapeutics reported on June 23 that patients with geographic atrophy who were treated with OpRegen cell therapy in a Phase I/IIa clinical study showed mean improvement in visual acui...

7/3/2025
BreakingCataractFundingGlaucomaRetinaStudy
Donor Gives $40M to Ophthalmology Department at CU Anschutz in Colorado 
Donor Gives $40M to Ophthalmology Department at CU Anschutz in Colorado

An anonymous donor has given a $40 million gift for eye research to the Department of Ophthalmology at the University of Colorado (CU) AnschutzMedical Campus in Aurora, Colorado, the school announc...

7/3/2025
BreakingFundingGene TherapyRetina
Children’s Hospital Los Angeles Receives $12M Gift to Expand Cell, Gene Therapies
Children’s Hospital Los Angeles Receives $12M Gift to Expand Cell, Gene Therapies

Children’s Hospital Los Angeles reported May 21 that it had received a $12 million gift from Alfred E. Mann Charities to establish a cell and gene therapy research endowment and a shorter-term fund...

6/27/2025
BreakingCataractRetina
Alcon Unity Cataract and Dual-Function Systems Gain Approval in Brazil
Alcon Unity Cataract and Dual-Function Systems Gain Approval in Brazil

Alcon announced June 12 that its dual-function Unity Vitreoretinal Cataract System (VCS) and stand-alone Unity Cataract System (CS) had gained market approval from the Brazilian Health Regulatory A...

6/27/2025
BreakingDiagnosticRetina
Zilia Gains Approval in Canada for its Fundus Camera With Ocular Oximetry
Zilia Gains Approval in Canada for its Fundus Camera With Ocular Oximetry

Quebec-based device maker Ziliareported June 19 that its Zilia Ocular device, a fundus camera that enables ocular oximetry, had gained approval from Health Canada. The company said it plans to laun...

6/27/2025
BreakingEuropeRegulationRetina
Scottish Regulators Endorse Outlook’s Lytenava for NHS Scotland Use in Wet AMD
Scottish Regulators Endorse Outlook’s Lytenava for NHS Scotland Use in Wet AMD

Outlook Therapeutics announced June 10 that the Scottish Medicines Consortium had recommended Lytenava (bevacizumab gamma) for use within its National Health Service system, NHS Scotland, for the t...

6/23/2025
AIMeetingNewsletterRetina
ARVO Sets Tone for AI-Focused Week With Avatar at Keynote Speech
ARVO Sets Tone  for AI-Focused Week With Avatar at Keynote Speech

The 2025 meeting of the Association for Research in Vision and Ophthalmology (ARVO) exceeded atten-dance expectations despite uncertainties sparked by US funding restrictions. The 10,915 attendees ...

6/23/2025
EarningsNewsletterRetinaRevenue
Ophthalmic Company Revenue in Q1-2025 Down 2.1 Percent as Multiple Firms Report Declines
Ophthalmic Company Revenue in Q1-2025 Down 2.1 Percent as Multiple Firms Report Declines

Ophthalmic manufacturer revenue in Q1-2025 totaled $11.0 billion. Revenue decreased 2.1 percent from the same quarter in 2024 and decreased 8.1 percent from Q4-2024. The total includes Market Scope...

6/20/2025
GlaucomaIOLNewsletterRefractiveRetina
Ophthalmologists Report 3.0 Percent Decrease in Q1-2025 Procedure Volume
Ophthalmologists Report 3.0 Percent Decrease in Q1-2025 Procedure Volume

US ophthalmologists reported that ophthalmic procedures decreased 3.0 percent in Q1-2025 compared with the same quarter in 2024, according to Market Scope’s latest survey. Year-over-year performanc...

6/23/2025
EuropeNewsletterRegulationRetina
Talks on Pharma Reforms Cloud Future of Europe’s Health Care Market
Talks on Pharma Reforms Cloud Future of Europe’s Health Care Market

The European Council—made up of the heads of the European Union’s member states—on June 4 advanced its position on pharmaceutical reforms, teeing up negotiations with the European Parliament and Co...

6/23/2025
DiagnosticNewsletterRegulationRetina
Select US FDA Approvals and Clearances in May 2025
Select US FDA Approvals and Clearances in May 2025

The US FDA’s ophthalmic device division granted clearance to one company’s technology using the 510(k) pathway in May 2025, according to the agency’s database. Heidelberg Engineering gained clearan...

6/23/2025
FundingNewsletterRetina
Regenxbio Leads Latest Ophthalmic Fundraising with $150 Million Royalty Sale
Regenxbio Leads Latest Ophthalmic Fundraising with $150 Million Royalty Sale

Regenxbio led recent ophthalmic fundraising efforts with a $150 million sale of future non-ophthalmic royalties to Healthcare Royalty (HCRx). Financing announced in the past four weeks totaled $535...

6/23/2025
NewsletterPharmaRetinaSurgical
Gore Launches Silicone-Free Plunger for Ophthalmic Prefilled Syringes
Gore Launches Silicone-Free Plunger for Ophthalmic Prefilled Syringes

Materials company W.L. Gore & Associates announced June 3 the commercial launch of its 0.5 mL silicone-free Improject syringe plunger. The new plunger is specifically designed for prefilled syringe...

6/23/2025
MeetingNewsletterPharmaRetinaSurgical
ARVO Showcases Manufacturers Looking to Refine Ocular Injections
ARVO Showcases Manufacturers Looking to Refine Ocular Injections

Big ideas typically dominate the headlines, such as AI, gene therapy, or oculomics, but innovation also happens in small things. The 2025 ARVO meeting displayed a surprising amount of attention to ...

6/23/2025
Clinical TrialGene TherapyMeetingNewsletterRetina
Batten Disease Candidate Leads the Way in New Gene Therapy Trials
Batten Disease Candidate Leads the Way in New Gene Therapy Trials

A presentation by Robert Henderson, MD (UK), on May 8 was a highlight of the many ARVO sessions on gene therapy. Henderson presented interim results from a clinical trial of a gene therapy candidat...

6/23/2025
EyeceleratorGene TherapyGlaucomaMeetingNewsletterRetina
Innovation and Collaboration Take Center Stage at Eyecelerator Meeting
Innovation and Collaboration Take Center Stage at Eyecelerator Meeting

For the first time, an Eyecelerator meeting preceded the ARVO annual conference, convening on May 2 at the Grand Hyatt Deer Valley in Park City, Utah. The event brought together 363 attendees, incl...

6/23/2025
Clinical TrialDry EyeGene TherapyNewsletterRefractiveRetinaSurgical
Clinical Trial Updates for Ophthalmic Candidates, June 2025
Clinical Trial Updates for Ophthalmic Candidates, June 2025

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

6/23/2025
Cell TherapyCornealDealsDiagnosticEmergingGene TherapyGlaucomaNewsletterOculomicsRetina
Emerging Companies Pursuing Ophthalmic Indications, June 2025
Emerging Companies Pursuing Ophthalmic Indications, June 2025

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

6/23/2025
BiosimilarsCornealMyopiaNewsletterPresbyopiaRegulationRetina
PDUFA Dates for Ophthalmic Drug Candidates, June 2025
PDUFA Dates for Ophthalmic Drug Candidates, June 2025

The US FDA has scheduled the following Prescription Drug User Fee Act (PDUFA) target action dates for ophthalmic drug, drug/device, and biologic candidates.

6/23/2025
AIChinaClinical TrialDealsDiagnosticDigitalDry EyeEuropeFundusGene TherapyGlaucomaIndustryMyopiaNewsletterRegulationRetina
June 2025 Ophthalmic News Briefs
June 2025 Ophthalmic News Briefs

Bausch + Lomb announced June 4 the US launch of Blink Nourish and Blink Boost over-the-counter lubricating eye drops. Both products are preservative-free and come in a 10 mL multi-dose bottle. Blin...

6/20/2025
BreakingRetinaStudy
NIH Study Determines Brain Circuits Affected by Retinal Cell Loss
NIH Study Determines Brain Circuits Affected by Retinal Cell Loss

Researchers at the National Institutes of Health have determined which vision-processing cells in the brain are affected by damaged retinal ganglion cells (RGCs). Current vision restoration therapi...

6/20/2025
BreakingClinical TrialGene TherapyRegulationRetina
US FDA Gives Green Light to Phase II/III Trial of Ocugen’s Stargardt Candidate
US FDA Gives Green Light to Phase II/III Trial of Ocugen’s Stargardt Candidate

Ocugen announced June 16 that the US FDA had cleared an investigational new drug (IND) application for a Phase II/III trial of its OCU410ST subretinal gene therapy candidate for ABCA4-associated re...

6/13/2025
BreakingGene TherapyIndustryRetina
Beacon Therapeutics Appoints Daniel Chung, DO, as Chief Medical Officer
Beacon Therapeutics Appoints Daniel Chung, DO, as Chief Medical Officer

Beacon Therapeutics announced June 9 that it had appointed Daniel Chung, DO, as chief medical officer. Chung most recently served as chief medical officer of the ophthalmic gene therapy company Spa...

6/13/2025
BreakingGene TherapyIndustryRegulationRetina
ViGeneron Rebrands as VeonGen, Gains Rare Pediatric Nod for Stargardt Candidate
ViGeneron Rebrands as VeonGen, Gains Rare Pediatric Nod for Stargardt Candidate

Germany’s ViGeneron announced June 5 its rebranding to VeonGen Therapeutics. VeonGen has advanced two gene therapy programs into clinical development—VG801 for Stargardt disease and other ABCA4-rel...

6/6/2025
BreakingEuropePharmaRetina
Outlook Launches Lytenava (Bevacizumab) in Germany, UK for Wet AMD
Outlook Launches Lytenava (Bevacizumab) in Germany, UK for Wet AMD

Outlook Therapeutics announced June 2 that it had launched Lytenava (bevacizumab gamma) in Germany and the UK for the treatment of wet age-related macular degeneration (AMD). The company said it wa...

6/6/2025
BreakingInstrumentsPharmaRetina
Gore Launches Silicone-Free Plunger for Ophthalmic Prefilled Syringes
Gore Launches Silicone-Free Plunger for Ophthalmic Prefilled Syringes

Materials company W.L. Gore & Associates announced June 3 the commercial launch of its 0.5 mL silicone-free Improject syringe plunger. The new plunger is specifically designed for prefilled syringe...

5/30/2025
BreakingChinaRetina
Bayer Receives Approval in China for High-Dose Eylea in Wet AMD
Bayer Receives Approval in China for High-Dose Eylea in Wet AMD

German drugmaker Bayer announced May 22 that China’s National Medical Products Administration had granted marketing authorization for high-dose Eylea (aflibercept 8 mg) for the treatment of wet age...

5/30/2025
BreakingCell TherapyRetinaStudySurgical
New Scleral Clamp Allows Delivery of Two Cell Grafts in Same Eye for Comparing Effects
New Scleral Clamp Allows Delivery of Two Cell Grafts in Same Eye for Comparing Effects

Scientists with the National Institutes of Health have shown that a new surgical technique can successfully deliver two cell grafts in adjacent subretinal locations in the same eye—allowing direct ...

5/30/2025
BiosimilarsBreakingRegulationRetina
US FDA Sets Decision Date of Oct. 21 for Xbrane’s Lucentis Biosimilar Candidate
US FDA Sets Decision Date of Oct. 21 for Xbrane’s Lucentis Biosimilar Candidate

Sweden’s Xbrane Biopharma announced May 23 that the US FDA had accepted the resubmitted biologics license application (BLA) for its Lucentis (ranibizumab) biosimilar. The FDA set a decision date of...

5/30/2025
AIBreakingDiagnosticDigitalEuropeRegulationRetina
Deepeye TPS AI Support Tool for Wet AMD Treatment Gains CE Marking
Deepeye TPS AI Support Tool for Wet AMD Treatment Gains CE Marking

Germany’s Deepeye Medical announced May 21 that its Deepeye TPS artificial intelligence assistant had been granted CE marking in the EU as a Class IIa medical device. The company said medical assis...

5/30/2025
BreakingGene TherapyRegulationRetina
US FDA Grants Rare Pediatric Designation to Ocugen’s Gene Therapy Candidate for Stargardt
US FDA Grants Rare Pediatric Designation to Ocugen’s Gene Therapy Candidate for Stargardt

Ocugen announced May 27 that the US FDA had granted rare pediatric disease designation to its OCU410ST subretinal gene therapy candidate for ABCA4-associated retinopathies, including Stargardt dise...

5/23/2025
BreakingDealsGene TherapyRetina
Dyno Launches New Capsid for Ophthalmic Gene Therapy Developers
Dyno Launches New Capsid for Ophthalmic Gene Therapy Developers

Dyno Therapeutics, of Watertown, Massachusetts, has launched a new adeno-associated virus (AAV) capsid for ophthalmic gene therapies, in addition to capsids for neuromuscular and central nervous sy...

5/23/2025
BreakingPharmaRegulationRetina
US FDA Approves Genentech’s Susvimo Refillable Implant for DR
US FDA Approves Genentech’s Susvimo Refillable Implant for DR

Genentech, a member of the Roche Group, announced May 22 that the US FDA had approved Susvimo, a refillable ranibizumab implant, for diabetic retinopathy (DR). The South San Francisco, California, ...

5/23/2025
BreakingDealsFundingGene TherapyRetina
Regenxbio Moves to Monetize Future Royalties in Deal Worth up to $250 Million
Regenxbio Moves to Monetize Future Royalties in Deal Worth up to $250 Million

Gene therapy developer Regenxbio announced May 19 that it had closed a non-dilutive royalty bond agreement worth up to $250 million with Healthcare Royalty (HCRx). The Rockville, Maryland, company ...

5/23/2025
BreakingPharmaRegulationRetina
US FDA Grants Breakthrough Status to Belite Bio’s Oral Stargardt Candidate
US FDA Grants Breakthrough Status to Belite Bio’s Oral Stargardt Candidate

Belite Bio announced May 21 that the US FDA had granted breakthrough therapy status to tinlarebant, an oral tablet targeting Stargardt disease. Sponsor companies receiving breakthrough designation ...

5/21/2025
AIDealsDigitalNewsletterRetina
Topcon Healthcare Acquires RetInSight to Advance AI-Powered Imaging in Eye Care
Topcon Healthcare Acquires RetInSight to Advance AI-Powered Imaging in Eye Care

Topcon Healthcare announced May 2 that it had acquired privately held retinal AI analysis company RetInSight, of Austria. No financial details were disclosed. The companies forged a partnership in ...

5/21/2025
DiagnosticDry EyeFundusGlaucomaIOLLaserNewsletterRefractiveRegulationRetina
Select US FDA Approvals and Clearances in April 2025
Select US FDA Approvals and Clearances in April 2025

Device makers gained US FDA clearance for seven technologies through the ophthalmic device division using the 510(k) pathway in April 2025, according to the agency’s database. BVI Medical received ...

5/21/2025
DealsDiagnosticDry EyeFundingGlaucomaLaserNewsletterPresbyopiaRetina
Therini Bio Leads Latest Ophthalmic Fundraising with $39 Million in Series A
Therini Bio Leads Latest Ophthalmic Fundraising with $39 Million in Series A

Therini Bio led recent ophthalmic fundraising efforts with $39 million in Series A funding to advance its lead candidate targeting the inflammatory component of fibrin. Financing announced in the p...

5/21/2025
Cell TherapyClinical TrialNewsletterRetina
GA Patients in Eyestem Cell Therapy Trial Show Significant Improvement
GA Patients in Eyestem Cell Therapy Trial Show Significant Improvement

India’s Eyestem Research reported April 15 that patients with geographic atrophy (GA) in a Phase I trial of its Eyecyte-RPE cell therapy saw significant vision improvement. Eyecyte-RPE is a cryopre...

5/21/2025
ASCRSCataractMeetingNewsletterRetinaSurgical
Alcon Emphasizes Efficiency of Unity VCS and CS Systems at ASCRS Launch
Alcon Emphasizes Efficiency of Unity VCS and CS Systems at ASCRS Launch

Surgeons attending the 2025 ASCRS meeting in Los Angeles dropped by Alcon’s booth for multiple presentations of the new Unity dual-function and cataract machines, rather than gathering in big numbe...

5/21/2025
Clinical TrialIndustryNewsletterRetina
Unity Bio to Cut Workforce, Seek Strategic Alternatives for UBX1325 in Retina
Unity Bio to Cut Workforce, Seek Strategic Alternatives for UBX1325 in Retina

Unity Biotechnology announced May 5 that it would reduce its workforce and seek an established ophthalmic company to continue the development of intravitreal UBX1325, a Tie2/anti-VEGF bispecific an...

5/21/2025
Clinical TrialCornealGene TherapyGlaucomaIOLNewsletterRetinaSurgical
Clinical Trial Updates for Ophthalmic Candidates, May 2025
Clinical Trial Updates for Ophthalmic Candidates, May 2025

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

5/21/2025
BiosimilarsNewsletterRegulationRetina
Four Eylea Biosimilars Get Q-Codes for Billing Payers in the US
Four Eylea Biosimilars Get Q-Codes for Billing Payers in the US

The Centers for Medicare and Medicaid Services (CMS) issued product-specific Q-codes for four Eylea biosimilars during Q4-2024 and Q1-2025. Q-codes are billing codes for reimbursement that are simi...

5/21/2025
CornealEmergingGlaucomaNewsletterRetina
Emerging Companies Pursuing Ophthalmic Indications, May 2025
Emerging Companies Pursuing Ophthalmic Indications, May 2025

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

5/21/2025
CataractCornealDealsDiagnosticDry EyeIndustryInstrumentsNewsletterPharmaPresbyopiaRefractiveRegulationRetinaSurgical
May 2025 Ophthalmic News Briefs
May 2025 Ophthalmic News Briefs

London’s Okyo Pharma announced April 30 that it would accelerate development of topical urcosimod, formerly OK-101, in neuropathic corneal pain, following early closure of its Phase II trial. The t...

5/16/2025
BiosimilarsBreakingCataractDry EyeGlaucomaIOLLaserOcular CancerRetinaRevenueSurgical
Q1-2025 Ophthalmic Revenue Roundup for Alcon, Immunocore, Harrow, Sight Sciences, ANI, Iridex, and Xbrane
Q1-2025 Ophthalmic Revenue Roundup for Alcon, Immunocore, Harrow, Sight Sciences, ANI, Iridex, and Xbrane

Alcon reported May 13 that its Q1-2025 net sales were $2.45 billion, on par with $2.44 billion in Q1-2024 and up 3 percent on a constant currency basis. Surgical net sales totaled $1.33 billion (do...

5/16/2025
BreakingClinical TrialDealsIndustryRetina
Unity Bio to Cut Workforce, Seek Strategic Alternatives for UBX1325 in Retina
Unity Bio to Cut Workforce, Seek Strategic Alternatives for UBX1325 in Retina

Unity Biotechnology announced May 5 that it would reduce its workforce and seek an established ophthalmic company to continue the development of UBX1325, a Tie2/anti-VEGF bispecific antibody candid...

5/16/2025
BreakingCataractDiagnosticIndustryRefractiveRetinaSurgical
Maximilian Foerst to Lead Carl Zeiss Meditec, as Markus Weber, PhD, Steps Down
Maximilian Foerst to Lead Carl Zeiss Meditec, as Markus Weber, PhD, Steps Down

Carl Zeiss Meditec announced May 7 that Markus Weber, PhD, the company’s president and CEO, will step down of his own accord, effective May 31. Replacing Weber will be Maximilian Foerst, currently ...

5/9/2025
AIBreakingDealsDiagnosticOculomicsRetina
Topcon Healthcare Acquires RetInSight to Advance AI-Powered Imaging in Eye Care
Topcon Healthcare Acquires RetInSight to Advance AI-Powered Imaging in Eye Care

Topcon Healthcare announced May 2 that it had acquired privately held retinal AI analysis company RetInSight, of Austria. No financial details were disclosed. The companies forged a partnership in ...

5/9/2025
BiosimilarsBreakingCataractDry EyeIOLRefractiveRetinaRevenueSurgicalThyroid Eye Disease
Q1-2025 Ophthalmic Revenue Roundup for Amgen, Hoya, Apellis, Tarsus, STAAR, RxSight, and Ocular Therapeutix
Q1-2025 Ophthalmic Revenue Roundup for Amgen, Hoya, Apellis, Tarsus, STAAR, RxSight, and Ocular Therapeutix

​ Amgen, of Thousand Oaks, California, reported May 1 that its Q1-2025 revenue from Tepezza was $381 million, a 10 percent decrease from $424 million in Q1-2024. The total consisted of $365 million...

5/9/2025
BreakingDiagnosticFundusRegulationRetina
US FDA Grants Marketing Clearance for OcuSciences’ OcuMet Beacon Retinal Imager
US FDA Grants Marketing Clearance for OcuSciences’ OcuMet Beacon Retinal Imager

OcuSciences, of Ann Arbor, Michigan, announced May 1 that the US FDA had granted marketing clearance for its flagship device, the OcuMet Beacon retinal imager. The 510(k) clearance describes the Oc...

5/9/2025
AIBreakingDiagnosticEuropeFundusRegulationRetina
RetinAI and FVS Gain CE Marking for LuxIA DR Screening Algorithm
RetinAI and FVS Gain CE Marking for LuxIA DR Screening Algorithm

Switzerland’s RetinAI and Spain’s Fundación Ver Salud (FVS) announced April 30 that LuxIA, their co-developed artificial intelligence algorithm for diabetic retinopathy screening, had received CE m...

5/9/2025
BreakingGene TherapyRegulationRetina
US FDA Grants RMAT Status to Opus’ LCA5 Gene Therapy Candidate
US FDA Grants RMAT Status to Opus’ LCA5 Gene Therapy Candidate

Opus Genetics announced May 6 that the US FDA had granted regenerative medicine advanced therapy (RMAT) designation to OPGx-LCA5, its investigational gene therapy for the treatment of Leber congeni...

5/9/2025
BreakingGene TherapyRegulationRetina
US FDA Grants RMAT Status to 4DMT’s Gene Therapy Candidate in DME
US FDA Grants RMAT Status to 4DMT’s Gene Therapy Candidate in DME

4D Molecular Therapeutics announced May 1 that the US FDA had granted regenerative medicine advanced therapy (RMAT) designation to 4D-150, an intravitreal gene therapy candidate for diabetic macula...

5/2/2025
BiosimilarsBreakingCornealDry EyeGlaucomaLaserRetinaRevenue
Q1-2025 Ophthalmic Revenue Roundup for Roche, Regeneron, AbbVie, Glaukos, Lumibird, and Biogen
Q1-2025 Ophthalmic Revenue Roundup for Roche, Regeneron, AbbVie, Glaukos, Lumibird, and Biogen

Swiss company Roche reported April 24 that Vabysmo sales in Q1-2025 were CHF 1 billion ($1.1 billion, calculated March 31, 2025), up 18 percent in constant currency from CHF 847 million in Q1-2024....

4/25/2025
BreakingCell TherapyClinical TrialRetina
GA Patients in Eyestem Phase I Cell Therapy Trial Show Significant Vision Improvement
GA Patients in Eyestem Phase I Cell Therapy Trial Show Significant Vision Improvement

India’s Eyestem Research reported April 15 that patients with geographic atrophy (GA) in a Phase I trial of its Eyecyte-RPE cell therapy saw significant vision improvement. Eyecyte-RPE is a cryopre...

4/25/2025
BiosimilarsBreakingRegulationRetina
Four Eylea Biosimilars Get Q-Codes for Billing Payers in the US
Four Eylea Biosimilars Get Q-Codes for Billing Payers in the US

The Centers for Medicare and Medicaid Services (CMS) issued product-specific Q-codes for four Eylea biosimilars during Q4-2024 and Q1-2025. Q-codes are billing codes for reimbursement that are simi...

4/25/2025
ASCRSBreakingCataractMeetingRetinaSurgical
Alcon Rolls Out Unity VCS and CS Systems at ASCRS Meeting
Alcon Rolls Out Unity VCS and CS Systems at ASCRS Meeting

Alcon announced April 25 the launch of its dual-function Unity Vitreoretinal Cataract System (VCS) and stand-alone Unity Cataract System (CS) in four markets, including the US. The announcement cam...

4/25/2025
BreakingPharmaRegulationRetina
US FDA Rejects Regeneron’s sBLA for Eylea HD Dosing Interval Beyond 16 Weeks
US FDA Rejects Regeneron’s sBLA for Eylea HD Dosing Interval Beyond 16 Weeks

Regeneron announced April 18 that the US FDA had issued a complete response letter rejecting the company’s supplemental biologics license application (sBLA) to add extended dosing intervals up to e...

4/25/2025
BreakingEuropeFundingMeetingRetina
May 12 is Deadline to Apply for Ramin Tadayoni Award for Research
May 12 is Deadline to Apply for Ramin Tadayoni Award for Research

Applications are open until May 12, 2025, for this year’s Ramin Tadayoni Award, offered by the European Society of Retina Specialists, or Euretina, and supported by Oculis as a tribute to retina sp...

4/21/2025
NewsletterRegulationRetina
US FDA Accepts Outlook’s Resubmitted BLA for Lytenava, Sets PDUFA Date of Aug. 27
US FDA Accepts Outlook’s Resubmitted BLA for Lytenava, Sets PDUFA Date of Aug. 27

Outlook Therapeutics announced April 8 that the US FDA had accepted the resubmitted biologics license application (BLA) for ONS-5010 (bevacizumab-vikg, Lytenava), an ophthalmic formulation of bevac...

4/21/2025
IOLIndustryNewsletterPharmaPremiumRetina
Retina Pharma and Premium IOLs Continue to Drive Ophthalmic Market
Retina Pharma and Premium IOLs Continue to Drive Ophthalmic Market

The ophthalmology industry produced an estimated $48.8 billion in revenue in 2024, with an expected compound annual growth rate (CAGR) of 4.5 percent. Market Scope estimates the industry will reach...

4/21/2025
Clinical TrialIndustryNewsletterRetina
Opthea Discontinues Wet AMD Program After Second Phase III Trial Misses Endpoint
Opthea Discontinues Wet AMD Program After Second Phase III Trial Misses Endpoint

Opthea announced March 31 its decision to discontinue development of sozinibercept (OPT-302) in wet age-related macular degeneration (AMD) after a second Phase III trial missed its primary endpoint...

4/21/2025
Clinical TrialGene TherapyGlaucomaNewsletterPharmaRetinaSurgical
Clinical Trial Updates for Ophthalmic Candidates, April 2025
Clinical Trial Updates for Ophthalmic Candidates, April 2025

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

4/21/2025
AIDiagnosticEmergingGene TherapyNewsletterPerimetryRetinaThyroid Eye Disease
Emerging Companies Pursuing Ophthalmic Indications, April 2025
Emerging Companies Pursuing Ophthalmic Indications, April 2025

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

4/21/2025
BiosimilarsDealsNewsletterRetina
Biocon’s Deal with Regeneron Will Bring Yesafili to Market in US No Later than H2-2026
Biocon’s Deal with Regeneron Will Bring Yesafili to Market in US No Later than H2-2026

India’s Biocon Biologics reported April 15 that it had reached a settlement and license agreement with Regeneron that clears the way for Biocon to commercialize Yesafili, a biosimilar to Eylea, in ...

4/21/2025
Low VisionNewsletterRetina
Thomas Panek Becomes President, CEO of Lighthouse Guild
Thomas Panek Becomes President, CEO of Lighthouse Guild

Lighthouse Guild announced March 18 that it had appointed Thomas Panek as its new president and CEO, effective April 1. Panek replaced Calvin Roberts, MD, who had led the nonprofit since April 2020...

4/21/2025
BiosimilarsCataractCornealDealsGlaucomaIOLIndustryLaserMyopiaNewsletterPharmaPresbyopiaRegulationRetinaSurgicalThyroid Eye DiseaseUveitis
April 2025 Ophthalmic News Briefs
April 2025 Ophthalmic News Briefs

Carl Zeiss Meditec announced March 21 the availability in Canada of the Visulas Combi, a green and YAG ophthalmic laser workstation combining photodisruption, photocoagulation, and slit lamp techno...

4/18/2025
BiosimilarsBreakingRetina
Biocon Reaches Settlement, License Agreement with Regeneron to Bring Yesafili to Market in US
Biocon Reaches Settlement, License Agreement with Regeneron to Bring Yesafili to Market in US

India’s Biocon Biologics reported April 15 that it had reached a settlement and license agreement with Regeneron that clears the way for Biocon to commercialize Yesafili, a biosimilar to Eylea, in ...

4/18/2025
BreakingClinical TrialIndustryRetina
Opthea Will Lay Off 65 Percent of Employees after Phase III Wet AMD Failures
Opthea Will Lay Off 65 Percent of Employees after Phase III Wet AMD Failures

Opthea plans to lay off about 65 percent of its workforce, effective May 1, the company said in a corporate update filed April 10 with the with the US Securities and Exchange Commission (SEC). The ...

4/18/2025
BreakingGene TherapyRegulationRetina
US FDA Grants RMAT Status to Atsena’s X-Linked Retinoschisis Gene Therapy Candidate
US FDA Grants RMAT Status to Atsena’s X-Linked Retinoschisis Gene Therapy Candidate

Atsena Therapeutics announced April 15 that the US FDA had granted regenerative medicine advanced therapy (RMAT) designation to ATSN-201, its gene therapy candidate for X-linked retinoschisis (XLRS...

4/11/2025
BreakingPharmaRegulationRetina
US FDA Accepts Outlook’s Resubmitted BLA for Lytenava, Sets PDUFA Date of Aug. 27
US FDA Accepts Outlook’s Resubmitted BLA for Lytenava, Sets PDUFA Date of Aug. 27

Outlook Therapeutics announced April 8 that the US FDA had accepted the resubmitted biologics license application (BLA) for ONS-5010 (bevacizumab-vikg, Lytenava), an ophthalmic formulation of bevac...

4/4/2025
BreakingClinical TrialRetina
Opthea Discontinues Wet AMD Trials After Second Phase III Trial Misses Endpoint
Opthea Discontinues Wet AMD Trials After Second Phase III Trial Misses Endpoint

Opthea announced March 31 its decision to discontinue development of sozinibercept (OPT-302) in wet age-related macular degeneration (AMD) after a second Phase III trial missed its primary endpoint...

4/4/2025
BiosimilarsBreakingDry EyeGlaucomaLaserRetinaRevenue
2024 Ophthalmic Revenue Roundup for Harrow, Astellas, Iridex, and Xbrane
2024 Ophthalmic Revenue Roundup for Harrow, Astellas, Iridex, and Xbrane

Nashville, Tennessee-based Harrow reported March 27 that its 2024 revenue was $199.6 million, a 53 percent increase over $130.2 million in 2023. The company generated record quarterly revenue in Q4...

4/4/2025
BreakingIndustryRetina
Aviceda Appoints Jeffrey Nau, PhD, MMS, as Chief Executive Officer
Aviceda Appoints Jeffrey Nau, PhD, MMS, as Chief Executive Officer

Aviceda Therapeutics announced April 1 that it had appointed Jeffrey Nau, PhD, MMS, as chief executive officer, effective immediately. Nau will also join the company’s board of directors, Aviceda s...

3/28/2025
BreakingClinical TrialRetina
Opthea, Unity Candidates Miss Clinical Trial Endpoints vs. Aflibercept
Opthea, Unity Candidates Miss Clinical Trial Endpoints vs. Aflibercept

Opthea and Unity Biotechnology reported results March 24 for their retinal treatment candidates that failed to meet or beat Regeneron’s Eylea (aflibercept) in clinical trials for wet AMD and DME, r...

3/28/2025
BreakingChinaRegulationRetinaSingle-Use
Chinese Regulators Approve DORC’s ILM-Blue Ocular Dye
Chinese Regulators Approve DORC’s ILM-Blue Ocular Dye

German company Carl Zeiss Meditec announced March 27 that China’s National Medical Products Administration (NMPA) had approved ILM-Blue ocular dye from DORC. The product is approved in the US as Ti...

3/28/2025
BreakingCornealFundingRetina
Surrozen to Focus on Ophthalmic Pipeline, Raises up to $175 Million in Private Placement
Surrozen to Focus on Ophthalmic Pipeline, Raises up to $175 Million in Private Placement

Surrozen announced March 24 that it would focus on its ophthalmic pipeline, including the development of new treatment options for retinopathies. Concurrently, the company said that a private place...

3/28/2025
BreakingDiagnosticGlaucomaLaserRetina
Zeiss Launches Visulas Combi in Canada
Zeiss Launches Visulas Combi in Canada

Carl Zeiss Meditec announced March 21 the availability in Canada of the Visulas Combi, a green and YAG ophthalmic laser workstation combining photodisruption, photocoagulation, and slit lamp techno...

3/21/2025
BreakingDealsRegulationRetinaUveitis
US FDA Expands Label for Iluvien to Include Chronic Non-infectious Posterior Uveitis
US FDA Expands Label for Iluvien to Include Chronic Non-infectious Posterior Uveitis

ANI Pharmaceuticals, of Baudette, Minnesota, announced March 14 that the US FDA had approved an expanded label for Iluvien (fluocinolone acetonide intravitreal implant 0.19 mg) to include treatment...

3/21/2025
BreakingLow VisionRetina
Thomas Panek to Lead Lighthouse Guild
Thomas Panek to Lead Lighthouse Guild

Lighthouse Guild announced March 18 that it had appointed Thomas Panek as its new president and CEO, effective April 1. Panek replaces Calvin Roberts, MD, who has led the nonprofit since April 2020...

3/21/2025
BiosimilarsBreakingDealsEuropeRetina
Xbrane to Sell Part of Company to Alvotech, Plans to Keep Ximluci
Xbrane to Sell Part of Company to Alvotech, Plans to Keep Ximluci

Sweden’s Xbrane will sell its Cimzia biosimilar candidate and parts of its organization to Iceland’s Alvotech for SEK 275 million ($27.1 million), the two companies reported March 20. Xbrane will r...

3/21/2025
BreakingDealsLow VisionRetina
Vivani Now Intends to Spin Out Cortigent, Developer of Orion Implant
Vivani Now Intends to Spin Out Cortigent, Developer of Orion Implant

Vivani Medical, of Alameda, California, reported March 12 that it intends to spin off its Cortigent neurostimulation business, formerly Second Sight Medical Products, into a fully independent, publ...

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