<a href="https://laohu8.com/S/IRD">Opus Genetics</a> Secures FDA IND Clearance for OPGx-BEST1 Gene Therapy, Paving the Way for Phase 1/2 Trial Launch in 2025
Opus Genetics Inc., a clinical-stage biopharmaceutical company specializing in gene therapies for inherited retinal diseases (IRDs), announced that the U.S. Food and Drug Administration (FDA) has granted clearance for its Investigational New Drug $(IND.AU)$ application for OPGx-BEST1. This gene therapy candidate is designed to treat bestrophin-1 (BEST1)-related IRD, a rare inherited retinal condition leading to progressive vision loss. With this IND clearance, Opus Genetics plans to commence a Phase 1/2 clinical trial in the latter half of 2025. The trial will evaluate the safety, tolerability, and preliminary efficacy of a single subretinal injection of OPGx-BEST1, marking a significant advancement for patients with no currently approved treatments.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Opus Genetics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9513657-en) on August 18, 2025, and is solely responsible for the information contained therein.
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