newsfilter
← Latest News
GlobeNewswire·

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

Successful Type B RDEP Meeting confirms FDA alignment on pivotal Phase 3 study designFDA indicates Opus Genetics may submit a BLA based on 6-month efficacy data, with 12-month durability data provided during