Opus Genetics Announces FDA Acceptance of OPGx-LCA5 into Rare Disease Evidence Principles (RDEP) Program
Opus Genetics announced that its investigational gene therapy OPGx-LCA5 for Leber congenital amaurosis type 5 (LCA5), a rare inherited retinal disease, has been accepted into the FDA's Rare Disease Evidence Principles (RDEP) program. This acceptance supports collaboration with the FDA on regulatory strategy and clinical trial design, potentially ac…