Opus Genetics reached FDA alignment on an eight-patient phase III trial of its inherited childhood blindness gene therapy candidate, OPGx-LCA5. The company said the regulatory alignment supports the next development stage for the ultra-rare program and clarifies trial design expectations for U.S. review. The trial focuses on LCA5, where small patient populations can make trial conduct especially sensitive to endpoint definitions and operational feasibility. Opus’ update adds scheduling clarity for sponsors working in ultra-rare gene therapy settings. If enrollment and follow-through proceed on plan, the phase III study becomes a key gate for potential registration and a possible expansion of the gene therapy treatment ecosystem for inherited retinal disease.