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.
Breaking News
BVI Medical’s FineVision HP Trifocal IOL Gains US FDA Approval
BVI Medical announced Oct. 14 that the US FDA had approved its FineVision HP trifocal intraocular lens (IOL). The company said the lens, the world’s first trifocal IOL, was backed by 15 years of cl...
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...
Iantrek Announces US Commercial Launch of AlloFlo Uveo Biostent for Glaucoma
Iantrek announced Oct. 14 the US commercial launch of the AlloFlo Uveo, a novel minimally invasive glaucoma surgical (MIGS) device targeting the uveoscleral drainage pathway. The AlloFlo Uveo allog...
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...
Epion Therapeutics Forms Strategic Partnership with Oculus
Epion Therapeutics announced Oct. 7 that it had entered a strategic partnership with Germany’s Oculus, maker of the Pentacam corneal topographer. The partnership comes in conjunction with Epion clo...
Biotech Healthcare Launches Optiflex Xtense Comfort Plus EDOF IOL in Europe
Biotech Healthcare announced Sept. 23 that it had launched the Optiflex Xtense Comfort Plus extended-depth-of-focus (EDOF) intraocular lens at the ESCRS 2025 congress in Copenhagen, Denmark. Biotec...
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...
Konan Medical’s ObjectiveField Perimeter Gains CE Marking
Konan Medical announced Oct. 10 that its ObjectiveField visual field analyzer had gained CE marking under the European Medical Device Regulation. The ObjectiveField is an objective perimeter design...
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...
US FDA Gives Green Light to Trial of Avisi’s VisiPlate Aqueous Shunt for Glaucoma
Avisi Technologies announced Oct. 14 that the US FDA had signed off on its investigational device exemption (IDE) submission, allowing the company to proceed with a trial of the VisiPlate aqueous s...
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....
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...
Nova Eye’s iTrack Advance Canaloplasty Device Approved in China
Australia’s Nova Eye Medical announced Sept. 30 that China’s National Medical Products Administration had approved the marketing of the company’s iTrack Advance canaloplasty device for glaucoma. Th...
US Senator to Review AMA’s Fee Structure to Use its CPT Code Set
US Senator Bill Cassidy, MD, R-Louisiana, has opened a review into the American Medical Association (AMA), claiming it charges “exorbitant fees” for use of its CPT code set. The code set is created...
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...
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...
Rayner Gains US FDA Approval of RayOne EMV Toric IOL
UK-based Rayner announced Oct. 13 that the US FDA had approved its RayOne EMV Toric intraocular lens (IOL), and the lens is now available. Rayner CEO Tim Clover said: “The long-awaited FDA approval...
Generic Drugmakers with US Sources Now Eligible for FDA Priority Review
The US FDA reported Oct. 3 that a new pilot program would speed the approval process for some generic drugmakers: They would be eligible for priority review if they conducted any required bioequiva...
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...
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 ...
Vivani Delays Record Date for Cortigent Spinoff Due to Shutdown
Vivani Medical, of Alameda, California, reported Oct. 3 that it has temporarily withdrawn the record date for spinning off its Cortigent subsidiary due to delays arising from the current shutdown o...
Harrow Names Frank Mullery as CEO of ImprimisRx Subsidiary
Harrow, of Nashville, Tennessee, announced Oct. 6 that Frank Mullery had been appointed chief executive officer of its ImprimisRx ophthalmic compounding subsidiary. Harrow said Mullery is a senior ...
Myopia Lenses from EssilorLuxottica Gain US FDA De Novo Marketing Authorization
Eyewear giant EssilorLuxottica and the US FDA announced Sept. 25 that the company’s Stellest spectacle lenses had gained de novo marketing authorization to slow the progression of myopia in childre...
Harrow to Expand Access for All Program to Full Drug Portfolio
Harrow, of Nashville, Tennessee, reported Sept. 25 that it was expanding its Vevye Access for All program to the rest of its portfolio, making it easier and more affordable for patients to obtain t...
Lenz Launches Vizz Drops for Presbyopia in US
Lenz Therapeutics announced Sept. 30 that Vizz (aceclidine ophthalmic solution) 1.44% for presbyopia is now commercially available in the US. The company said its sales force was distributing sampl...
Kala to Shut Down Eye Drop Program for Corneal Defect After Phase IIb Failure
Kala Bio reported Sept. 29 that it would cease development of lead asset KPI-012 and end its mesenchymal stem cell secretome program after the eye drop candidate failed to reach its primary endpoin...
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...
Harrow Agrees to Reacquire Melt Pharmaceuticals
Harrow, of Nashville, Tennessee, reported Sept. 26 that it had agreed to reacquire Melt Pharmaceuticals, a clinical stage company developing sedation and analgesia medicines for short-duration medi...
Klotho Agrees to Acquire Turn Bio’s Technology Designed to Restore Cell Function
Klotho Neurosciences reported Sept. 30 that it had signed a letter of intent to acquire select assets from Mountain View, California-based Turn Biotechnologies. Details of the proposed cash and sto...
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,...
STAAR Counters Opposition to Alcon Acquisition
STAAR Surgical reported Sept. 26 that its second largest active stockholder, Soleus Capital Master Fund, with 6 percent of outstanding shares, intends to vote in favor of Alcon’s acquisition of STA...
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...
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...
Topcon Launches Tera Imager for Detection and Management of Dry Eye
Topcon Healthcare announced Sept. 18 the launch of its Tera Dry Eye Imager, a multimodal platform designed to detect, grade, and manage dry eye disease. Topcon said Tera pairs automation with high-...
Horizon Surgical Systems Names Rajesh Rajpal, MD, as CMO, CSO
Horizon Surgical Systems, of Malibu, California, announced Sept. 23 that it appointed Rajesh K. Rajpal, MD, as its chief medical officer (CMO) and chief strategy officer (CSO). Horizon is developin...
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...
Amneal Gains US FDA Approval for Generic Bimatoprost 0.01% Eye Drop
Amneal Pharmaceuticals announced Sept. 23 that it had received US FDA approval for its generic bimatoprost ophthalmic solution 0.01% (2.5 mL, 5 mL, and 7.5 mL), which references AbbVie’s Lumigan. B...
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...
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.
STAAR’s Largest Shareholder to Vote Against Alcon Acquisition
New York-based Broadwood Partners, STAAR Surgical’s largest shareholder, filed a preliminary proxy statement with the SEC on Sept. 15, urging fellow shareholders to reject Alcon’s acquisition of ST...
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...
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...
FDA Drug Official Looks to End Advisory Panel Meetings
US FDA leaders may end advisory panel meetings that weigh the risks and benefits of drugs, KFF Health News reported Sept. 12. The news outlet quoted George Tidmarsh, MD, PhD, head of the FDA’s Cent...
Moria’s Donor Cornea Storage Medium Xtra4 Gains US FDA 510(k) Clearance
France’s Moria Surgical announced Sept. 12 that the US FDA had granted 510(k) clearance to Xtra4, a storage medium designed to preserve human donor corneas for up to 14 days under refrigeration (35...
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...
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...
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 ...
Vivani Sets Date for Spin-off of Cortigent Subsidiary (Formerly Second Sight)
Vivani Medical, of Alameda, California, reported Sept. 17 that it had set the record date for its spin-off of Cortigent, its subsidiary developing brain implant devices. Vivani shareholders holding...
€1 Million Champalimaud Vision Award Goes to Three Prominent Eye Charities
The winners of the 2025 António Champalimaud Vision Award are the Fred Hollows Foundation; Lions Clubs International Foundation (LCIF) with its SightFirst program; and the International Agency for ...
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...
New World Medical Launches ClearPath ST with Smaller Tube Lumen
New World Medical (NWM) announced Sept. 2 that it had launched the Ahmed ClearPath ST glaucoma drainage device, featuring a smaller tube lumen, or diameter. NWM, of Rancho Cucamonga, California, sa...
EuroEyes Acquires Seven Betterview Clinics in Switzerland, Plus UK Assets
EuroEyes has acquired seven betterview refractive surgery clinics across Switzerland for CHF 12 million ($15 million, converted Sept. 2, 2025), plus betterview’s assets in the UK for an additional ...
Eyexora, Cofounded by Bill Link, Launches at Futures Forum
Cofounders Bill Link, PhD, and Theresa Heah, MD, MBA, launched their new company, Eyexora, on Sept. 11 at the Ophthalmology Futures European Forum 2025 in Copenhagen, Denmark. They describe the com...
UCLA Study Reveals Complex Muscle Control Behind Blinking and Eyelid Function
A team of biomechanical engineers and ophthalmologists at the University of California, Los Angeles, has uncovered new details about the muscle that controls blinking. The researchers said the work...
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...
EMA Grants Orphan Status for Aldeyra’s Methotrexate Formulation in PRVL
Aldeyra Therapeutics announced Aug. 28 that the European Medicines Agency (EMA) had granted orphan designation for ADX-2191 (methotrexate intravitreal injection) for certain cancers, including prim...
Haag-Streit Announces Appointment of Thomas Lenzen as CEO
Swiss ophthalmic diagnostics company Haag-Streit announced Sept. 1 the appointment of Thomas Lenzen as chief executive officer. The company said Lenzen brings more than two decades of international...
Todd Bazemore Becomes Kala President and CEO; Will Take Seat on Board
Kala Bio announced Sept. 2 that interim CEO Todd Bazemore had been named to the job officially, along with the role of president and a seat on the company’s board. Bazemore had served as Kala’s int...
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...
Mina Massaro-Giordano, MD, to Lead New Dry Eye Service at NYU Langone
NYU Langone Health announced Aug. 28 that dry eye specialist Mina Massaro-Giordano, MD, had been appointed to lead its newly established Dry Eye Service in the Department of Ophthalmology. Massaro-...
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...
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...
HHS Agrees to Restore Deleted Web Pages in Lawsuit Settlement
The US Department of Health and Human Services has agreed to restore public health web pages and datasets that it removed under an executive order in January, according to two plaintiffs involved i...
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...
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...
Santen Gains Approval in Japan for Setaneo (Sepetaprost) Glaucoma Drops
Japan’s Santen announced Aug. 25 that it had gained manufacturing and marketing approval in Japan for Setaneo (sepetaprost 0.002%) eye drops for glaucoma and ocular hypertension. The prodrug, origi...
US FDA Begins Daily Reporting of Adverse Event Data
The US FDA announced Aug. 22 that it had begun daily publication of adverse event data, aiming to modernize its system for drug oversight and reaffirm its commitment to protecting public health. Th...
Zeiss Gains CE Marking for Cirrus PathFinder AI Tool With Automated OCT Analysis
Germany’s Carl Zeiss Meditec announced Aug. 21 that it had received CE marking in Europe for the Cirrus PathFinder, an artificial intelligence (AI) tool for analysis of optical coherence tomography...
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...
Ocumetics Implants First Patients in Trial of its Accommodating IOL
Ocumetics Technology, of Calgary, Canada, announced Aug. 18 that the first patients had been implanted in a clinical study of its accommodating intraocular lens (IOL). The company said the procedur...
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...
Ciliatech’s Intercil Uveal Spacer for Glaucoma Gains CE Marking
France’s Ciliatech announced Aug. 27 that European regulators had granted CE marking for the Intercil Uveal Spacer, a surgical implant for glaucoma. The Intercil, also known as the cilioscleral int...
Eyebot to Expand Self-Serve Vision-Testing Kiosks with $20 Million Financing
Eyebot, of Boston, Massachusetts, plans to use the $20 million it raised in a Series A round in August 2025 to expand its vision testing kiosks to new retail locations. The kiosks—located in malls,...
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...
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...
Glaucoma Research Foundation to Use $5 Million Gift to Create Accelerator
The Glaucoma Research Foundation reported Aug. 20 that it plans to use a $5 million gift from the John and Daria Barry Foundation—the largest single donation in the foundation’s history—to launch t...
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...
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...
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...
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...
Researchers See Early Promise in Electromechanical Reshaping of Cornea
Researchers in California are exploring the possibility of electromechanical reshaping of the cornea for laser-free refractive surgery. Michael Hill, a professor of chemistry at Occidental College,...
Philippine Academy of Ophthalmology Warns of Fake Website for Congress
The Philippine Academy of Ophthalmology (PAO) issued a warning to the ophthalmic community on Aug. 21 of a fake website representing the group’s upcoming meeting. The fraudulent website encouraged ...
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...
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...
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 ...
Myra Vision Gains IDE Approval to Begin US Trial of Adjustable Glaucoma Shunt
Myra Vision announced Aug. 12 that the US FDA had issued a conditional approval letter for its investigational device exemption (IDE) application to initiate a US trial of its Calibreye titratable ...
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...
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...
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...
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)...
First Commercial Procedure Performed with BVI’s Laser Endoscopy System for Glaucoma
BVI Medical announced July 31 the first clinical use of its Leos laser endoscopy system for glaucoma. BVI, of Waltham, Massachusetts, says Leos offers a more intuitive, minimally invasive ab intern...
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...
VSY Biotechnology Launches Enova Hydrophobic IOLs with Rotaryjet Inserter
Germany’s VSY Biotechnology announced Aug. 8 that its Enova hydrophobic intraocular lens (IOL) line was now available with the company’s Rotaryjet preloaded delivery system. VSY said the Rotaryjet ...
Alcon Agrees to Acquire STAAR Surgical in Deal Worth $1.5 Billion
—STAAR’s Evo ICL fills a strategic gap in Alcon’s surgical portfolio, broadening its refractive product line while bolstering STAAR’s global commercialization. The Deal: Alcon will acquire STAAR Su...
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...
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...
Eye Physicians, Researchers Band Together to Stave Off NEI Cuts, Consolidation
The American Academy of Ophthalmology (AAO) announced July 23 that it had joined with other professional and vision research organizations to fight proposed funding cuts and consolidation threats a...
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...
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...
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...
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’...
US FDA Approves Lenz’ Vizz (Aceclidine) Drops for Presbyopia
Lenz Therapeutics announced July 31 that the US FDA had approved Vizz (aceclidine ophthalmic solution) 1.44% for presbyopia. The company said Vizz was the first once-daily, preservative-free eye dr...
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 ...
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 ...
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...
Alcon Launches Tryptyr (Acoltremon) Drops for Dry Eye in US
Alcon announced July 29 the US commercial availability of Tryptyr (acoltremon ophthalmic solution) 0.003% to treat the signs and symptoms of dry eye. Tryptyr is a first-in-class TRPM8 agonist, dose...
New Minnesota Law Expands ODs’ Authority to Prescribe Drugs, Perform Injections
A new law passed in Minnesota expands optometrists’ authority to prescribe certain medications and allows them to administer some in-office injections. The Minnesota Optometric Association (MOA) ha...
Innovia Medical Acquires Ophthalmic Surgical Instrument Maker Hurricane Medical
Innovia Medical, of St. Paul, Minnesota, reported July 2 that it had acquired Bradenton, Florida-based Hurricane Medical, manufacturer of ophthalmic surgical instruments, as well as Memphis, Tennes...
Glaukos Acquires Mobius Therapeutics and its Mitosol Antifibrotic Agent
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...
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...
UM Whole Eye Transplant Project Overcomes Two Hurdles
Two critical pieces needed to eventually transplant a whole eye have been created and tested successfully at the University of Miami, the school reported July 24. Seventeen UM faculty members are w...
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...
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...
Santen Launches Ryjunea Drops in Germany for Pediatric Myopia
Japan’s Santen Pharmaceutical announced July 22 that it had launched Ryjunea low-dose atropine eye drops in Germany for pediatric myopia. Germany is the first market for Ryjunea, which received EU ...
George Tidmarsh, MD, PhD, Named to Lead FDA’s Center for Drug Evaluation and Research
The US FDA reported July 21 that George Tidmarsh, MD, PhD, had been named director of the Center for Drug Evaluation and Research. Tidmarsh, a Stanford University faculty member and physician scien...
First Patient Treated in US Trial of Eyetronic Optic Nerve Therapy for Glaucoma
The Glaucoma Center of San Francisco announced July 21 that it had treated the first patient in the US as part of a clinical trial of Eyetronic, a non-invasive therapy to stimulate the optic nerve....
Viatris’ Phase III Blepharitis Ointment Candidate Fails to Reach Primary Endpoint
Viatris announced July 18 that a Phase III trial of pimecrolimus 0.3% (MR-139) ophthalmic ointment in blepharitis did not meet its primary endpoint of complete resolution of debris after six weeks ...
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...
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...
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...
Onconetix to Merge with Glaucoma Drop Maker Ocuvex
Onconetix, of Cincinnati, Ohio, announced July 16 a definitive merger agreement with Ocuvex, maker of Omlonti (omidenepag isopropyl 0.002%) drops for glaucoma. The combined company will carry the O...
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 ...
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...
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 ...
Glaucoma Laser Company ViaLase Appoints Shawn O’Neil as CEO
ViaLase announced July 8 that it had appointed Shawn O’Neil, formerly the company’s chief commercial officer, as chief executive officer. Company founder Tibor Juhasz, PhD, transitioned from CEO to...
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...
J&J Vision Generates Q2-2025 Surgical Revenue of $403 Million
J&J Vision’s Q2-2025 global surgical revenue totaled $403 million, a 9.9 percent increase (+8.9 percent cc) over $367 million in Q2-2024, parent Johnson & Johnson, of New Brunswick, New Jersey, rep...
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 ...
Kowa Licenses Nicox’ Glaucoma Drop for US, Other Territories in $222 Million Deal
France’s Nicox announced July 17 that Japan’s Kowa had licensed its glaucoma candidate, NCX 470 (0.1% bimatoprost), for the US and all other unlicensed territories in a deal worth up to €191.5 mill...
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...
EyeDura and its Eye Drop Platform Continue to Win Honors from Accelerators
EyeDura Therapeutics reported July 15 that the company had earned the Judges’ Choice and People’s Choice awards at the Octane Ophthalmology Tech Forum, held June 27 in Newport Beach, California. Th...
Israel’s PainReform Enters Ophthalmology with Investment in LayerBio
Israel’s PainReform announced July 10 that it had signed a strategic agreement with LayerBio, which is developing OcuRing-K, a sustained-release intraocular implant designed to deliver anti-inflamm...
Ocumetics Set to Begin First-in-Human Study of its Accommodating IOL
Ocumetics Technology, of Calgary, Canada, announced June 24 that it was set to begin a first-in-human clinical study of its accommodating intraocular lens (IOL). The company said all the lenses for...
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...
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...
Chinese Regulators Approve Perfluorohexyloctane Drops for Dry Eye with MGD
China’s Hengrui Pharmaceuticals and Germany’s Novaliq announced July 8 that China’s National Medical Products Administration had approved Heng Qin (perfluorohexyloctane eye drops) for dry eye assoc...
Rain Eye Drops Launches Dispensing Tool for Single-Use Vials to its Customers
Rain Eye Drops, of Las Vegas, Nevada, reported July 8 the launch of its RainDrop Dispenser Aid, a tool designed to help users apply eye drops from single-use vials more easily and accurately. The c...
RxSight Lowers 2025 Guidance Due to Q2-2025 Preliminary Results
RxSight reported July 8 that it was lowering its 2025 revenue guidance to $120 million to $130 million, down from the range of $185.0 million to $197.0 million provided on Feb. 25, 2025. The Aliso ...
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...
Lenz Licenses Presbyopia Drop Candidate to Théa for Canada in $70 Million Deal
Lenz Therapeutics announced July 7 that France’s Laboratoires Théa had licensed exclusive rights to market LNZ100 (1.75% aceclidine) for presbyopia in Canada. Lenz will receive more than $70 millio...
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...
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 ...
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...
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...
CMS to Increase Audits of Medicare Advantage Billing to Prevent Upcoding
Private insurers that take part in the US Medicare Advantage program will see enhanced and accelerated audits of their billing practices under an aggressive new plan, the Centers for Medicare and M...
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...
Ophthalmology Tops US Specialties for Percentage of Doctors in Private Practice
Ophthalmology had the highest share of physicians in private practice—70.4 percent—among all US specialties in 2024, according to a Physician Practice Benchmark Survey conducted every other year by...
Hoya Vision Care Acquires Canada’s Centennial Optical
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...
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...
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...
Uni-Bio Gains Approval in China for Diquafosol Sodium Eye Drops for Dry Eye
Hong Kong-based Uni-Bio Science reported May 21 that it had obtained marketing approval fromthe China National Medical Products Administration for its diquafosol sodium eye drops. Diquafosol sodium...
Health Insurers Pledge to Reform Prior Authorization by 2026
Major insurers of nearly 50 US health plans published a pledge on June 24 to simplify and reduce prior authorization of medical treatments, cutting the volume of treatments subject to such oversigh...
Glaukos Gains EU MDR Certification for Devices in iStent Platform
Glaukos, of Aliso Viejo, California, reported June 25 that it had received European Union (EU) Medical Device Regulation (MDR) certification for devices in its minimally invasive glaucoma surgery (...
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...
Presbyopia Drop Candidate from Viatris and Opus Meets Endpoints in Second Phase III Trial
Commercial partners Viatris and Opus Genetics reported June 26 that their presbyopia drop candidate, MR-141 (phentolamine ophthalmic solution 0.75%), met its primary endpoint and key secondary endp...
PolyActiva Names New CEO, Raises $25 Million to Advance Sustained-Release Glaucoma Implant
Australian company PolyActiva announced June 18 that it had appointed ophthalmic industry veteran Jerry St. Peter as chief executive officer. The company also closed a $25 million Series C funding ...
US FDA Gives Green Light to Phase III Trial of Zhaoke’s Cyclosporine Ophthalmic Gel
Hong Kong’s Zhaoke Ophthalmology announced June 4 that the US FDA had cleared the investigational new drug (IND) application for its 0.05% cyclosporine ophthalmic gel, targeting moderate to severe ...
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...
Amneal Gains US FDA Approval for Generic Prednisolone Acetate Eye Drop
Amneal Pharmaceuticals announced June 12 that it had received US FDA approval for its generic prednisolone acetate ophthalmic suspension, 1%, which references AbbVie’s Pred Forte. The sterile, topi...
VivaVision, US FDA Agree on Accelerated Path for Post-op Inflammation Candidate
VivaVision, of Wenzhou, China, announced June 9 that the US FDA had agreed on an accelerated regulatory pathway for the company’s VVN461LD, a potent JAK1/TYK2 inhibitor targeting inflammation follo...
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...
US FDA Aims to Speed Drug Review to Under Two Months With New Voucher Program
The US FDA reported June 17 the launch of a new priority review voucher program designed to review prescription drug applications within one to two months of submission. The current average is 10 t...
DEWS III Report Updates Guidelines for Diagnosis, Management of Dry Eye
The Tear Film and Ocular Surface Society (TFOS) has released DEWS III, its third set of reports exploring the diagnosis and management of dry eye disease. The findings of the TFOS Dry Eye Workshop ...
J&J Vision Launches Tecnis Odyssey PC-IOL in Europe, Middle East, and Canada
Johnson & Johnson Vision announced June 17 that it had rolled out the Tecnis Odyssey presbyopia-correcting intraocular lens (PC-IOL) in Europe, the Middle East, and Canada. The company, based in Ja...
Ascension Agrees to Buy Amsurg’s Network of ASCs
Ascension announced June 17 that it had agreed to acquire the Amsurg network of ambulatory surgery centers (ASCs). Terms were not disclosed. Amsurg operates more than 250 surgery centers in 34 stat...
Regeneron Declines to Submit New Bid for 23andMe After Higher Offer from Co-founder
Drugmaker Regeneron has declined to submit a new bid for genetic testing company 23andMe, a company spokesperson told Reuters on June 16. 23andMe reported June 13 that TTAM Research Institute, a no...
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...
Aldeyra Resubmits NDA to US FDA for Reproxalap in Dry Eye
Aldeyra Therapeutics announced June 17 that it had resubmitted its new drug application (NDA) to the US FDA for topical ocular reproxalap in dry eye. Aldeyra reported in May that reproxalap achieve...
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...
Harrow Acquires US Rights to Formosa’s Clobetasol, Now Branded Byqlovi
Harrow announced June 9 that it had acquired the US commercial rights to Formosa Pharmaceuticals’ clobetasol propionate 0.05% eye drops for postsurgical inflammation and pain. According to a filing...
Spain’s Faes Farma Acquires Italy’s SIFI in Deal Worth $310.4 Million
Faes Farma, of Bilbao, Spain, announced June 11 that it had signed an agreement to acquire 100 percent of Italian ophthalmic company SIFI. The deal values SIFI at €270 million (US $310.4 million, c...
Qlaris Bio Will Advance Fixed-Dose Combo Therapy for Glaucoma with QLS‑111 and Latanoprost
Qlaris Bio announced June 11 that it is developing a preservative-free, fixed-dose combination therapy with its lead asset, QLS-111, and latanoprost, a common prostaglandin analog prescribed for gl...
Chinese Regulators Approve Clarus 700 Ultra-Widefield Fundus Camera from Zeiss
Germany’s Carl Zeiss Meditec announced June 6 that China’s National Medical Products Administration (NMPA) had approved the Clarus 700 high-definition, ultra-widefield fundus imaging system. The co...
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...
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...
FDA Begins Listening Tour with Pharma CEOs to Improve Regulatory Process
The US FDA is holding a listening tour, led by FDA Commissioner Marty A. Makary, MD, MPH,to meet directly with pharmaceutical and biotech CEOs, according to an announcement on May 28. The goal is t...
EssilorLuxottica to Acquire European Ophthalmology Clinic Chain Optegra
Eyewear conglomerate EssilorLuxottica announced May 30 that it would acquire the Optegra chain of ophthalmology clinics from the private equity firm MidEuropa. Financial details were not disclosed....
Bausch + Lomb Launches Blink Nourish and Blink Boost OTC Eye Drops in US
Bausch + Lomb announced June 4 the US launch of Blink Nourish and Blink Boost over-the-counter lubricating eye drops. The company said both products are preservative-free and contact lens friendly;...
Sydnexis Gains EU Approval for Low-Dose Atropine Drops in Pediatric Myopia
Sydnexis announced June 5 that the European Commission had granted marketing authorization for SYD-101, the company’s low-dose atropine formulation for slowing the progression of pediatric myopia. ...
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...
US FDA Accepts Tenpoint’s NDA for Presbyopia Drop, Sets PDUFA Date of Jan. 28, 2026
Tenpoint Therapeutics announced June 3 that the US FDA had accepted its new drug application (NDA) for Brimochol PF, a combination eye drop candidate targeting presbyopia. The FDA set a Prescriptio...
23andMe Seeks New Bids after $305 Million Offer from its Co-founder
Bankrupt genetic testing company 23andMe told a US judge that it wants to reopen bidding on its assets after receiving a $305 million offer from its co-founder Anne Wojcicki, Reuters reported June ...
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...
US FDA Approves Alcon’s Tryptyr (Acoltremon) Drops for Dry Eye
Alcon announced May 28 that the US FDA had approved Tryptyr (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512, for the treatment of the signs and symptoms of dry eye. The company ...
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...
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 ...
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...
EyeGo, Developer of Digital Ophthalmic Microdoser, Secures Strategic Investment from Topcon
Danish company EyeGo, developer of the MistGo Digital microdoser for ophthalmic medicine, announced May 16 a strategic investment from Topcon Healthcare. No financial details were disclosed. EyeGo ...
Formosa Licenses Clobetasol Drops to Adalvo for European, Brazilian Markets
Taiwan-based Formosa Pharmaceuticals announced May 28 that it had agreed to license to Malta’s Adalvo Limited exclusive rights to market clobetasol propionate 0.05% eye drops for postsurgical infla...
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...
iVeena Submits IND to US FDA for Phase II Trial of IVMED-85 in Pediatric Myopia
iVeena Delivery Systems announced May 29 that it had submitted an investigational new drug (IND) application to the US FDA for a Phase II trial of IVMED-85 in pediatric myopia. IVMED-85 is a non-at...
Allotex Launches Refractive Corneal Implant in Canada
Allotex announced May 22 the approval and launch in Canada of Transform, its human collagen-based corneal implant for vision correction. The company said it had partnered with Clarion Medical Techn...
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...
Atia Vision Gains IDE Approval to Begin US Trial of Modular Accommodating IOL
Atia Vision announced May 20 that the FDA had approved its investigational device exemption (IDE) application to begin a US feasibility study of its OmniVu modular accommodating lens system for cat...
Q1-2025 Ophthalmic Revenue Roundup for Bausch + Lomb and Carl Zeiss Meditec
Bausch + Lomb reported April 30 that its Q1-2025 revenue was $1.14 billion, a 3 percent increase (+5 percent cc) over $1.10 billion in Q1-2024. Vision Care segment revenue in Q1-2025 was $656 milli...
US FDA Gives Green Light to Phase II Trial of Immunoglobulin Eye Drop from Selagine, Grifols
Chicago-based Selagine and its partner Grifols, of Barcelona, Spain, announced May 21 that the US FDA had cleared an investigational new drug (IND) application for a Phase II trial of their GRF312 ...
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...
Regeneron Buys 23andMe, Says Move will Strengthen its Genetics-Guided Drug Development
Regeneron, of Tarrytown, New York, reported May 19 that it had been named the successful bidder in a bankruptcy auction for the assets of 23andMe, a company that provides direct-to-consumer genetic...
SIFI Gains Marketing Authorization, PIM Designation for Akantior Drops in UK
Italy’s SIFI reported May 19 that it had gained marketing authorization from the UK’s Medicines and Healthcare Products Regulatory Agency for Akantior eye drops for the treatment of Acanthamoeba ke...
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, ...
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