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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…

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,…

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…

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…

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…

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 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…

Phenocell SAS and Amarna Therapeutics have been awarded the prestigious Eurostars grant to advance their collaborative gene therapy platform targeting dry age-related macular degeneration (AMD). This partnership combines Phenocell’s innovative in vitro AMD disease model with Amarna’s proprietary gene delivery…

ACELYRIN has announced that the Phase 2b/3 clinical trial evaluating izokibep for non-infectious, non-anterior uveitis did not achieve its primary endpoint. The trial results did not demonstrate a statistically significant improvement in time to treatment failure versus placebo. Consequently, the…

2024 Recap is here! Click to review:Top 8 FDA Approvals in Opthalmology In a series of groundbreaking developments, the FDA has approved a range of innovative drugs in 2023, heralding a new era in ophthalmic treatments. Here’s an in-depth look…