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

FDA clearance enables clinical development of OPGx-RDH12 for RDH12-associated Leber congenital amaurosis, a rare inherited retinal disease that causes progressive vision loss beginning in early childhood

Strategic collaboration with the Global RDH12 Alliance supports the development of a potential treatment for this disease with high unmet need

RESEARCH TRIANGLE PARK, N.C., Oct. 21, 2026 (GLOBE NEWSWIRE) — Opus Genetics, Inc. (NASDAQ:IRD) (“Opus Genetics” or the “Company”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for OPGx-RDH12, an investigational gene therapy for the treatment of RDH12-associated Leber congenital amaurosis (RDH12-LCA), a rare inherited retinal disease that causes progressive vision loss and blindness beginning in early childhood.

The IND clearance enables Opus Genetics to advance OPGx-RDH12 into clinical development, marking an important achievement in the Company’s collaboration with the Global RDH12 Alliance, which brings together patient advocacy organizations RDH12 Fund for Sight in the United States and Eyes on the Future in the United Kingdom. The partnership was established in July 2025 with the goals of accelerating development of OPGx-RDH12 and bringing a potential treatment to patients living with this devastating condition.