Opus Genetics Wins FDA Clearance for Childhood Blindness Gene Therapy

07:56 AM EDT, 10/21/2026 (MT Newswires) -- Opus Genetics (IRD) said Wednesday that the US Food and Drug Administration cleared its investigational new drug application for OPGx-RDH12, a gene therapy candidate for a rare inherited disease that causes childhood vision loss. The clearance enables clinical development of the gene therapy, with a phase 1/2 trial planned for Q4 2026 to target the disease's underlying genetic cause, the company said. Opus Genetics is developing the therapy with the Global RDH12 Alliance, which committed up to $1.6 million under a July 2025 agreement. Eligible costs will be reimbursed as work is completed, subject to specified milestones and obligations, the company said. The alliance includes RDH12 Fund for Sight and Eyes on the Future, the company added.