- Tags: retina
Legal
Regeneron settles with Sandoz over Eylea biosimilar patent infringement lawsuit
Agreement enables FDA-approved Enzeevu (aflibercept-abzv) to launch in Q4 2026, or potentially earlier.
Research
What factors impact visual acuity in intermediate AMD?
Study identifies three key features that impact visual acuity in patients with intermediate AMD.
Business
OpZira launches with LumiThera diagnostic product line
Spin-off company official forms following Alcon-LumiThera acquisition to offer two ophthalmic products: the AdaptDx Pro and NOVA Vision Testing System.
Business
Alcon officially purchases LumiThera
Acquisition of the Valeda Light Delivery System includes plans to expand commercial market availability in 2026.
Pipeline
FDA grants RMAT designation to Nanoscope for Stargardt gene therapy
MCO-010 optogenetic therapeutic has potential to become first-ever treatment for Stargardt; phase 3 trial expected to kick off in Q4 2025.
Products
identifeye HEALTH launches AI-based retinal screening platform
The FDA-registered, compact, app-based portable system is designed to detect early signs of ocular and systemic disease in point-of-care settings.
Pipeline
Outlook Therapeutics receives second FDA CRL over wet AMD BLA
Agency rejects submission of bevacizumab-vikg for a second time, citing a single issue with the application: a lack of effectiveness data.
Research
Study: IRDs are on the rise in the United States
Improvements in diagnostic testing likely explains increase in incidence and prevalence of IRDs.
Research
Are blue light-filtering IOLs beneficial for AMD?
Blue light-filtering IOLs demonstrate no protective effect on the risk of developing exudative AMD.
Pipeline
FDA extends review period for EYLEA HD expanded labeling
Delay follows a recent site inspection; proposed expansion includes a new indication, updated dosings for current indications, and a pre-filled syringe version.
Pipeline
FDA grants RMAT designation to VeonGen's Stargardt therapy
Status marks third designation for the VG801, intended to treat patients with biallelic
Pipeline
jCyte doses first patients in RP allogeneic cell therapy trial
Phase 2b JC02-88 trial to evaluate a single IVT injection of jCell (famzeretcel), an agnostic cell therapy with the potential to restore vision in all RP genetic subtypes.
Business
Opthea to lay off 80% of workforce amid executive cuts
Company also announces cuts to Board of Directors as the CEO is among several planned departures beginning in September.
Pipeline
Avista and Forge Biologics partner to advance XLRS gene therapy
Collaboration leverages Forge’s in-house AAV development and manufacturing services for AVST-101, an AAV-based IVT gene therapy.
Pipeline
FDA clears Opus Genetics' IND for BEST1 IRD gene therapy
Company plans to initiate phase 1/2 clinical trial on OPGx-BEST1, a potential first-ever treatment for this patient base.
Pipeline
FDA agrees to SPA for Ocular Therapeutix NPDR registrational trial
Agreement includes planned design for study evaluating AXPAXLI (formerly OTX-TIKI), an IVT implant with the potential for long-term durability and fewer injections.
Events
Ophthalmology Tech Forum explores next frontier in retina diagnostics and treatment
Annual industry event covered gene therapy, pipeline treatments, and technology innovations for retinal disease.
Events
Registration opens for Eyes On Retina 2025
The premier virtual event of the year for retina-focused ECPs kicks off in October—with the chance to claim up to 5 hours of CE/CME.
Pipeline
FDA grants Fast Track designation to AAVantgarde's Stargardt gene therapy
Status benefits clinical study of AAVB-039, an AAV8 intended to address the disease’s root cause by delivering the full-length ABCA4 gene via a single subretinal injection.
Products