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Opus Gets FDA SPA for APX3330 Phase 3 Trial
Opus Genetics has announced a key regulatory milestone, securing a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for its Phase 3 clinical trial of APX3330. The oral treatment is being evaluated for moderate to…
EYLEA HD Succeeds in Phase 3 RVO Trial
Regeneron Pharmaceuticals has announced that its Phase 3 QUASAR trial evaluating EYLEA HD (aflibercept 8 mg) has met its primary endpoint, marking a significant advancement in the treatment of retinal vein occlusion (RVO). About the QUASAR Trial The QUASAR trial…
Aurion’s AURN001 Shows Positive Phase 1/2 Results
Aurion Biotech has released topline data from its Phase 1/2 clinical trial (CLARA), evaluating AURN001, an allogeneic cell therapy product candidate for treating corneal edema secondary to corneal endothelial dysfunction. These results highlight the therapy’s potential as a groundbreaking treatment…
FDA Clears ViGeneron’s VG801 for Stargardt Disease
The U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for VG801, ViGeneron’s novel gene therapy candidate designed to treat Stargardt disease and other retinal dystrophies caused by mutations in the ABCA4 gene. This marks…
Veligrotug Delivers Positive Results in Phase 3 TED Trial
Viridian Therapeutics has announced positive topline results from the Phase 3 THRIVE-2 clinical trial evaluating veligrotug, an anti-insulin-like growth factor-1 receptor (IGF-1R) antibody, for the treatment of chronic thyroid eye disease (TED). The trial met its primary and secondary endpoints,…
EMA Backs Celltrion’s Aflibercept Biosimilar
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion and marketing authorization recommendation for Eydenzelt, Celltrion’s biosimilar to aflibercept (Eylea). This marks a significant milestone for Celltrion, a South Korea-based biopharmaceutical…
2023 Recap: Top 15 Research in Ophthalmology
2024 Recap is here! Click to review:Top 10 Breakthroughs in Ophthalmology Research In the fast-evolving landscape of ophthalmology research, 2023 has proven to be a pivotal year marked by groundbreaking discoveries and innovation. From revolutionary cell replacement therapies to novel…
HORA-PDE6b Gets FDA Rare Pediatric Disease Status
eyeDNA Therapeutics, a newly created subsidiary of Coave Therapeutics, has announced that the U.S. Food and Drug Administration (FDA) has granted a Rare Pediatric Disease Designation (RPDD) for HORA-PDE6b, the company’s novel gene therapy designed to treat inherited retinal dystrophy…
Vabysmo Prefilled Syringe Approved in EU
The European Medicines Agency (EMA) has approved Roche’s Vabysmo (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for the treatment of wet age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). A Convenient Treatment…
Atsena Completes XLRS Gene Therapy Trial Dosing
Atsena Therapeutics has successfully completed dosing in Part A of the LIGHTHOUSE study, a Phase I/II clinical trial evaluating the subretinal delivery of ATSN-201 for the treatment of X-linked retinoschisis (XLRS). The study represents an important step forward in developing…