Opus Genetics Announces FDA Alignment on Phase 3 Registrational Trial Design for OPGx-LCA5 in LCA5-Associated Inherited Retinal Disease

Opus Genetics announced successful FDA alignment on its Phase 3 clinical trial design for OPGx-LCA5, a gene therapy for LCA5-associated inherited retinal disease. The FDA indicated the company may submit a Biologics License Application based on 6-month efficacy data, with 12-month durability data provided during review. Phase 3 dosing is expected to begin in Q4 2026, with seven of eight planned participants already enrolled.