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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…

Phenocell & Amarna Win Eurostars Grant

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 Halts Izokibep Development | OBN

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…

Top 12 Ophthalmic Drugs That Received FDA Approval

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…

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