Opus Genetics announced U.S. FDA alignment on an eight-patient Phase III trial for OPGx-LCA5, its lead gene therapy targeting an ultra-rare inherited childhood blindness condition. The company positioned the agreement as clearing a key regulatory path for a small, high-impact study design. The Phase III plan is built around feasibility in rare disease settings, where limited patient populations require streamlined development. FDA alignment reduces uncertainty on trial structure, endpoints, and operational planning. For investors and competitors, the announcement reinforces how rare disease gene therapy programs increasingly rely on early agency alignment to accelerate execution toward potential submissions.