FDA Clears Opus Genetics’ IND Application For Opgx-RDH12, Investigational Gene Therapy For Treatment Of RDH12-Associated Leber Congenital Amaurosis

Opus Genetics, Inc. (NASDAQ: IRD) has received FDA clearance for its Investigational New Drug (IND) application for OPGx-RDH12, a gene therapy aimed at treating RDH12-associated Leber congenital amaurosis, a rare inherited retinal disease. This clearance allows the company to proceed with clinical development of the therapy, which is part of a strategic collaboration with the Global RDH12 Alliance established in July 2025 to expedite treatment development for patients with this condition.