Opus Genetics Confirms FDA Alignment On Phase 3 Study Design To Evaluate OPGx-LCA5

Opus Genetics (OPGx-LCA5) said it reached alignment with the FDA in a Type B Rare Disease Evidence Principles meeting regarding the design of its registrational Phase 3 trial for LCA5-associated inherited retinal disease. The FDA feedback supports the planned clinical trial structure, which modestly reduces regulatory uncertainty heading into enrollment.

Analysis

Opus Genetics (OPGx-LCA5) said it reached alignment with the FDA in a Type B Rare Disease Evidence Principles meeting regarding the design of its registrational Phase 3 trial for LCA5-associated inherited retinal disease. The FDA feedback supports the planned clinical trial structure, which modestly reduces regulatory uncertainty heading into enrollment.