Opus Genetics said it secured U.S. FDA alignment on an eight-patient Phase III trial of its gene therapy OPGx-LCA5 for an ultra-rare inherited childhood blindness indication. The regulatory alignment clarifies the Phase III study design pathway, giving the company a defined development route as it moves toward pivotal data. For gene therapy sponsors, FDA alignment on trial configuration can reduce late-stage uncertainty about endpoints, dosing, and eligibility criteria, which in turn supports planning for manufacturing scale-up and long-lead clinical logistics. Opus will now proceed with execution of the Phase III plan, with attention on recruitment pace and the durability of visual function outcomes given the small cohort size.