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.
Regulation 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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
Ciliatech’s Intercil Uveal Spacer for Glaucoma Gains CE Marking; Already Cleared in UK
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...
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...
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...
Select US FDA Approvals and Clearances in August 2025
The US FDA’s ophthalmic device division granted clearance to two devices using the 510(k) pathway in August 2025, according to the agency’s database. Forus Health gained clearance for its 3nethra N...
FDA 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...
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 ...
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...
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...
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 ...
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...
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...
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...
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...
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...
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...
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 ...
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...
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...
Select US FDA Approvals and Clearances in July 2025
The US FDA’s ophthalmic device division granted clearance to one device using the 510(k) pathway in July 2025, according to the agency’s database. Tomey gained clearance for its Casia2 OCT anterior...
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...
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 ...
New HHS Plan Adds Prior Authorization to Medicare
A new program by the US Department of Health and Human Services (HHS) to test using prior authorization for 15 procedures in traditional Medicare is raising concerns among Democratic lawmakers and ...
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...
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 ...
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...
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...
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...
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...
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...
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 ...
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...
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...
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...
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...
Chinese Companies Launch Wave of New Ophthalmic Products at Home
China’s ophthalmic market is riding a wave of new Chinese offerings, spurred on by policies promoting the locali-zation of medical products. New products from Chinese companies approved by the Nati...
Select US FDA Approvals and Clearances in June 2025
The US FDA’s ophthalmic device division granted clearance to three devices using the 510(k) pathway in June 2025, according to the agency’s database. Zeiss received clearance for its Micor 700 syst...
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...
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...
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.
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...
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...
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...
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...
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...
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...
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...
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 (...
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...
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 ...
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...
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...
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 ...
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...
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...
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...
ARVO Attendees Share Concern Over Present and Future of Vision Research
The tidal wave of sudden cuts and restrictions to funding for vision and ophthalmic research cast a long shadow over the 2025 ARVO meeting. They came up formally and informally throughout the six-d...
Eyecelerator Meeting’s Expert Panelists Portray an FDA in Flux
A panel at the Eyecelerator meeting on May 2 ahead of ARVO brought together a deeply experienced and knowledgeable group to examine the recent changes at the US FDA and their impact on the ophthalm...
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. ...
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.
Weekly Corporate and Surgeon Polls, June 2025
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...
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...
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...
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...
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...
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...
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 ...
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...
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...
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 ...
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, ...
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 ...
Bausch + Lomb Ends Recall of enVista IOLs After Tracking Source of Contamination
Bausch + Lomb announced April 24 that it was ending its voluntary recall of enVista intraocular lenses (IOLs) after it tracked the source of contamination to a raw material used in certain lots tha...
Bausch + Lomb Receives CE Marking for Preloaded LuxLife Trifocal IOL
Bausch + Lomb announced May 7 that the LuxLife trifocal intraocular lens (IOL) had received CE marking in Europe. The company said the nondiffractive LuxLife has an uninterrupted, continuous refrac...
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 ...
Nearly 76 Thousand Cases of Ocular Lubricants Recalled, US FDA Alert Says
The US FDA issued alerts recently regarding the recalls of five ocular lubricant products and one generic glaucoma medication. BRS Analytical Services, a contract testing laboratory based in St. Lo...
Ballooning NHS Cataract Surgery Costs at Private Clinics Raise Red Flags
Fraud investigators in England’s National Health Service (NHS) are looking at the billing practices of private clinics delivering NHS cataract surgery after procedure volume and costs have balloone...
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...
US Policy Decisions Add Uncertainty to Ophthalmic Industry
The ophthalmic industry is facing uncertainty from US government policies on at least three fronts: an executive order designed to lower drug pricing, continually changing tariffs, and a budget bil...
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...
Nearly 76 Thousand Cases of Ocular Lubricants Recalled, US FDA Alert Says
The US FDA issued alerts recently regarding the recalls of five ocular lubricant products and one generic glaucoma medication. BRS Analytical Services, a contract testing laboratory based in St. Lo...
Intalight Receives CE Marking for Dream OCT Swept Source Imaging
Ophthalmic diagnostic company Intalight announced May 15 that it had received CE marking for its Dream optical coherence tomography (OCT) platform. Intalight, with offices in San Jose, California, ...
Bausch + Lomb Receives CE Marking for Preloaded LuxLife Trifocal IOL
Bausch + Lomb announced May 7 that the LuxLife trifocal intraocular lens (IOL) had received CE marking in Europe. The company said the nondiffractive LuxLife has an uninterrupted, continuous refrac...
US FDA Grants Breakthrough Status to Viridian’s Thyroid Eye Disease Candidate
Viridian Therapeutics announced May 7 that the US FDA had granted breakthrough therapy status to veligrotug, the company’s anti-insulin-like growth factor-1 receptor (IGF-1R) candidate for thyroid ...
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...
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...
Aldeyra Achieves Primary Endpoint in Phase III Dry Eye Chamber Trial of Reproxalap, Plans NDA Resubmission
Aldeyra Therapeutics reported May 5 that topical reproxalap achieved the primary endpoint of statistically significant improvement in ocular discomfort vs. vehicle in a Phase III dry eye chamber tr...
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...
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...
US FDA Extends Luminopia Amblyopia Treatment Clearance to Children Ages 8 to 12
Luminopia announced April 22 that the US FDA had cleared its amblyopia (lazy eye) treatment for patients ages 8 to 12, extending the age range of its existing label. The Luminopia system was grante...
New Laws in Montana, West Virginia Expand ODs’ Scope to Include Laser
Montana and West Virginia became the 13th and 14th US states, respectively, to pass laws expanding optometrists’ scope of practice to include in-office laser procedures. West Virginia’s measure spe...
Bausch + Lomb Ends Recall of enVista IOLs After Tracking Source of Contamination
Bausch + Lomb announced April 24 that it was ending its voluntary recall of enVista intraocular lenses (IOLs) after it tracked the source of contamination to a raw material used in certain lots tha...
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...
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...
Ballooning NHS Cataract Surgery Costs at Private Clinics Raise Red Flags
Fraud investigators in England’sNational Health Service (NHS) are looking at the billing practices of private clinics delivering NHS cataract surgery after procedure volume and costs have ballooned...
New Mexico Governor Vetoes Bill to Allow ODs to Perform SLT, YAG Capsulotomy
New Mexico Gov. Michelle Lujan Grisham on April 11 vetoed House Bill 36, which would have expanded the scope of practice for optometrists in the state, allowing them to perform selective laser trab...
US FDA Again Rejects Aldeyra’s Reproxalap for Dry Eye, Asks for Yet Another Symptom Trial
Aldeyra Therapeutics reported April 3 that the US FDA had once again issued a complete response letter rejecting the company’s new drug application (NDA) for topical reproxalap as a treatment for d...
Select US FDA Approvals and Clearances in March 2025
There was one US FDA clearance through the ophthalmic device division using the 510(k) pathway in March 2025, according to the agency’s database. CenterVue gained approval for its Maia scanning las...
Nordic Pharma Secures CE Marking for Lacrifill Canalicular Gel in Dry Eye
Nordic Group B.V., a Dutch affiliate of Nordic Pharma, announced April 7 that Lacrifill canalicular gel had received CE marking in Europe for the treatment of dry eye. Lacrifill is a cross-linked h...
PDUFA Dates for Ophthalmic Drug Candidates, April 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.
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...
Malvina Eydelman, MD, Named CEO of CCOI Organization
Longtime US FDA regulator and board-certified ophthalmologist Malvina Eydelman, MD, has stepped into a new role as chief executive officer of the Collaborative Community on Ophthalmic Innovation (C...
Job and Funding Cuts in US HHS Department Hit Ophthalmic Community
The Trump administration’s overhaul of the US Health and Human Services Department (HHS) through mass firings, funding cuts, and restructuring continues to affect those working to protect vision. J...
Bausch + Lomb Recalls Certain enVista IOLs Amid Reports of TASS Cases
Bausch + Lomb announced March 27 that it was voluntarily recalling certain intraocular lenses (IOLs) on its enVista platform. A letter to customers from Bausch + Lomb Chairman and CEO Brent Saunder...
US FDA Plans to Phase Out Animal Testing for Biologics, Drugs
The US FDA reported April 10 that it planned to phase out animal testing as part of the approval process for biologics and drugs, as the agency moves to more effective, human-relevant methods, call...
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...
US FDA Grants 510(k) Clearance to BVI’s Laser Endoscopy System for Glaucoma
BVI Medical announced April 17 that it had received US FDA 510(k) clearance for its Leos laser endoscopy system for glaucoma. The company said Leos offers a more intuitive, minimally invasive ab in...
Sanoculis Receives CE Marking for MINT Procedure for Glaucoma
Israel’s Sanoculis announced April 17 that it had received CE marking in the EU for its MINT (minimally invasive nasal trabeculostomy) procedure for adults with glaucoma. MINT features a mechanical...
US FDA Plans to Phase Out Animal Testing for Biologics, Drugs
The US FDA reported April 10 that it planned to phase out animal testing as part of the approval process for biologics and drugs, as the agency moves to more effective, human-relevant methods, call...
ACRO Biomedical Gains Regulatory Approval in Taiwan for Corneal Xenograft
Taiwan’s ACRO Biomedical announced April 13 that the country’s Ministry of Health and Welfare had granted regulatory approval to ACRO’s ABCcolla decellularized porcine collagen corneal xenograft. A...
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...
Tenpoint Submits NDA to US FDA for Brimochol PF in Presbyopia
Tenpoint Therapeutics announced April 8 that it had submitted a new drug application (NDA) to the US FDA for Brimochol PF, a combination eye drop candidate targeting presbyopia. In its Phase III tr...
Nordic Pharma Secures CE Marking for Lacrifill Canalicular Gel in Dry Eye
Nordic Group B.V., a Dutch affiliate of Nordic Pharma, announced April 7 that Lacrifill canalicular gel had received CE marking in Europe for the treatment of dry eye. Lacrifill is a cross-linked h...
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...
Chinese Regulators Approve Tapcom Fixed-Combo Glaucoma Drop from Santen
Japan’s Santen announced April 4 that China’s National Medical Products Administration had approved the marketing authorization application for Tapcom (tafluprost 0.0015%/timolol maleate 0.5% ), a ...
US FDA Again Rejects Aldeyra’s Reproxalap for Dry Eye, Asks for Yet Another Symptom Trial
Aldeyra Therapeutics reported April 3 that the US FDA had once again issued a complete response letter rejecting the company’s new drug application (NDA) for topical reproxalap as a treatment for d...
Malvina Eydelman, MD, Named CEO of CCOI Organization
Longtime US FDA regulator and board-certified ophthalmologist Malvina Eydelman, MD, has stepped into a new role as chief executive officer of the Collaborative Community on Ophthalmic Innovation (C...
Sydnexis Receives Positive CHMP Opinion for Low-Dose Atropine Drops in Pediatric Myopia
Sydnexis announced April 1 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended marketing authorization in the European Union for its low-dose ...
Bausch + Lomb Recalls Certain enVista IOLs Amid Reports of TASS Cases
Bausch + Lomb announced March 27 that it was voluntarily recalling certain intraocular lenses (IOLs) on its enVista platform. A letter to customers from Bausch + Lomb Chairman and CEO Brent Saunder...
Alcon Announces CE Mark Approval, European Launch of Clareon Vivity IOL
Alcon reported March 25 that the Clareon Vivity extended depth of focus (EDOF) intraocular lens (IOL) had received CE marking, along with the toric model, and will begin a commercial rollout in Eur...
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...
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...
Chinese Regulators Approve Innovent’s Sycume for Thyroid Eye Disease
China’s Innovent Biologics announced March 14 that Chinese regulators had approved Sycume, a recombinant anti-insulin-like growth factor 1 receptor antibody for thyroid eye disease (TED). Innovent ...
Changes in NIH Grant Rules Threaten to Ripple Through Eye Disease Research
Any changes to the rules that accompany US government research grants could affect eye research in the US in a big way. The US government awards an average of $1.1 billion a year in grants to resea...
US FDA Approves Neurotech’s Cell Therapy Implant for MacTel
Neurotech Pharmaceuticals announced March 6 that the US FDA had approved Encelto, an encapsulated cell therapy implant to treat macular telangiectasia (MacTel) type 2. It’s the first FDA-approved t...
PDUFA Dates for Ophthalmic Drug Candidates
The US FDA has scheduled the following Prescription Drug User Fee Act (PDUFA) target action dates for ophthalmic drug, drug/device, and biologic candidates.
Select US FDA Approvals and Clearances in February 2025
There was one US FDA clearance through the ophthalmic device division using the 510(k) pathway in February 2025, according to the agency’s database. New World Medical gained clearance of its Via360...
US FDA Accepts NDA for Glaukos’ Epioxa for Epi-On Crosslinking Therapy
Glaukos, of Aliso Viejo, California, reported Feb. 24 that the US FDA had accepted its new drug application for Epioxa, an epi-on version of the company’s iLink corneal crosslinking therapy, for th...
New Arkansas Law Reins in Vision Care Insurers’ Influence over ODs
Optometrists in Arkansas celebrated a legislative victory on Feb. 25 when Gov. Sarah Huckabee Sanders signed into law HB 1353, which supporters say will allow ODs in the state to receive more fair ...
Medicare Physician Fee Cut Won’t be Rolled Back in March
US House members on March 9 dropped language from a stopgap funding bill that would have rolled back the 2.83 percent cut in Medicare reimbursement for doctors that went into effect Jan. 1. The mov...
New World Medical Gains US Clearance for the Via360 Viscodilation System for Glaucoma
New World Medical announced Feb. 18 that it had received 510(k) clearance from the US FDA for its Via360 glaucoma surgical system. The Rancho Cucamonga, California, company said the device would be...
Weekly Corporate and Surgeon Poll, March 2025
March 2025 Ophthalmic News Briefs
Alcon announced the US launch Feb. 24 of its Systane Pro Preservative-Free (PF) over-the-counter eye drops for dry eye. The company said Systane Pro PF is the longest lasting eye drop in the Systan...
US FDA Accepts NDA for Sydnexis’ Low-Dose Atropine for Myopia, Sets PDUFA Date of Oct. 23, 2025
Sydnexis, of Del Mar, California, reported March 11 that the US FDA had accepted its new drug application for SYD-101, a low-dose atropine eye drop to slow the progression of pediatric myopia. The ...
US FDA Grants Fast Track Status to Atsena’s X-Linked Retinoschisis Gene Therapy Candidate
Atsena Therapeutics announced March 12 that the US FDA had granted fast track designation to ATSN-201, its gene therapy candidate for X-linked retinoschisis (XLRS). The candidate previously receive...
US FDA Approves Neurotech’s Cell Therapy Implant for MacTel
Neurotech Pharmaceuticals announced March 6 that the US FDA had approved Encelto, an encapsulated cell therapy implant to treat macular telangiectasia (MacTel) type 2. It’s the first FDA-approved t...
Outlook Resubmits BLA to US FDA for Ophthalmic Bevacizumab (Lytenava)
Outlook Therapeutics reported Feb. 28 that it had resubmitted its biologics license application (BLA) to the US FDA for ONS-5010 (Lytenava), an ophthalmic formulation of bevacizumab for wet age-rel...
US FDA Approves ANI Pharmaceuticals’ Cortrophin Gel in Prefilled Syringe
ANI Pharmaceuticals announced March 3 that the US FDA had approved a prefilled syringe of its purified Cortrophin gel. Among its many indications, the treatment targets acute and chronic inflammato...
Avirmax Initiates IND-Enabling Studies of Dry AMD Triple-Gene Therapy Candidate
Avirmax Biopharma announced Feb. 28 that it had begun investigational new drug (IND) enabling studies of ABI-201, a viral vector that delivers three genes with the goal of preventing retinal pathog...
Japanese Regulators Grant Orphan Drug Status to HanAll’s Batoclimab in Active Thyroid Eye Disease
South Korea’s HanAll Biopharma announced March 6 that Japanese regulators had granted orphan drug designation to batoclimab, a subcutaneous anti-FcRn treatment being developed for autoimmune diseas...
Ocugen’s Gene Therapy Candidates for GA and Stargardt Gain Advanced Therapy Status in Europe
Ocugen announced March 3 that European regulators had granted advanced therapy medicinal product status to OCU410 and OCU410ST, the company’s subretinal gene therapy candidates for geographic atrop...
US FDA Accepts NDA for Glaukos’ Epioxa, Sets PDUFA Date of Oct. 20, 2025
Glaukos, of Aliso Viejo, California, reported Feb. 24 that the US FDA had accepted its new drug application for Epioxa, an epi-on version of the company’s iLink corneal crosslinking therapy, for th...
Chinese Regulators Approve Zeiss’ VisuMax 800 with SMILE Pro Software
Germany’s Carl Zeiss Meditec announced Feb. 26 that the National Medical Products Administration in China had approved its updated VisuMax 800 femtosecond refractive laser and related SMILE Pro sof...
Formycon, Klinge Gain UK Approval for Eylea Biosimilar Under Brand Name Ahzantive
German companies Formycon and Klinge Biopharma announced Feb. 25 that the UK’s Medicines and Healthcare Products Regulatory Agency had granted marketing authorization for their Eylea biosimilar und...
Chinese Regulators Accept NDA for Arcatus (Xipere) in Uveitic Macular Edema
Clearside Biomedical announced Feb. 20 that Chinese regulators had accepted for review the new drug application (NDA) filed by Clearside’s Asia-Pacific partner, Arctic Vision, for Arcatus, known as...
Opus Gains FDA Fast Track Status for Phentolamine Drops for Night Driving Impairment
Opus Genetics announced Feb. 26 that the US FDA had granted fast track designation to the company’s phentolamine eye drop candidate for night driving impairment in keratorefractive patients. Ocuphi...
Celltrion Gains EU Approval for Aflibercept Biosimilar Branded Eydenzelt
South Korea’s Celltrion announced Feb. 18 that the European Commission had granted marketing authorization to Eydenzelt, an aflibercept (Eylea) biosimilar. Eydenzelt (40 mg/mL solution for injectio...
US FDA Grants RMAT Designation for Bionic Sight’s RP Gene Therapy Candidate
Bionic Sight announced Feb. 18 that the US FDA had granted regenerative medicine advanced therapy (RMAT) designation to BS01, the company’s gene therapy candidate targeting retinitis pigmentosa (RP...
US FDA Accepts BLA for Aflibercept Biosimilar Candidate from Alvotech, Teva
Alvotech announced Feb. 18 that the US FDA had accepted for review its biologics license application (BLA) for AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept). The company said it expe...
US FDA Grants RMAT Designation for Luxa’s Dry AMD Cell Therapy Candidate
Luxa Biotechnology, a joint venture between Korea’s Y2 Solutions and the Neural Stem Cell Institute in Rensselaer, New York, announced Feb. 18 that the US FDA had granted regenerative medicine adva...
Australian Regulators Approve Apellis’ Syfovre for Patients with Geographic Atrophy
Apellis Pharmaceuticals announced Jan. 27 that Australia’s Therapeutic Goods Administration had approved Syfovre (intravitreal pegcetacoplan) for the every-other-month treatment of adult patients w...
Appeals Court Upholds Injunctions Blocking Eylea Biosimilars from Samsung Bioepis and Formycon
In a victory for Regeneron, the US Court of Appeals for the Federal Circuit issued a ruling Jan. 29 upholding preliminary injunctions that block Samsung Bioepis and Formycon from launching their ap...
Select US FDA Approvals and Clearances in January 2025
There were no US FDA clearances through the ophthalmic device division using the 510(k) pathway in January 2025, according to the agency’s database. This is a departure from previous months, when i...
US FDA Approves Expanded Label for Izervay to Extend Treatment for GA Beyond 12 Months
Japan’s Astellas Pharma announced Feb. 12 that the US FDA had approved expanded labeling for Izervay (avacincaptad pegol intravitreal solution) for geographic atrophy (GA), extending the allowed du...
Ophthalmology Officials, Doctors, Researchers Feel Effects of Trump’s Sweeping Changes
The US ophthalmic community and larger health care industry have been affected by many policies implemented by the Trump administration since inauguration day on Jan. 20. Among the 3,600 employees ...
February 2025 Ophthalmic News Briefs
Outlook Therapeutics reported Jan. 16 the final results of the NORSE EIGHT trial of ONS-5010 (Lytenava), an ophthalmic formulation of bevacizumab for wet AMD. ONS-5010 demonstrated non-inferiority ...
US FDA Approves Expanded Label for Izervay to Extend Treatment for GA Beyond 12 Months
Japan’s Astellas Pharma announced Feb. 12 that the US FDA had approved expanded labeling for Izervay (avacincaptad pegol intravitreal solution) for geographic atrophy (GA), extending the allowed du...
US FDA Grants RMAT Designation for Beacon’s XLRP Gene Therapy Candidate
Beacon Therapeutics announced Jan. 28 that the US FDA had granted regenerative medicine advanced therapy (RMAT) designation to laru-zova (laruparetigene zovaparvovec, also known as AGTC-501), Beaco...
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