Opus Genetics announced that the U.S. Food and Drug Administration (FDA) cleared its Investigational New Drug (IND) application for OPGx-RDH12, an investigational gene therapy for RDH12-associated Leber congenital amaurosis (LCA). The rare inherited retinal disease causes progressive vision loss in young children.
The clearance allows Opus to begin a Phase 1/2 clinical trial, which the company plans to launch within the quarter. OPGx-RDH12 is the third program in Opus’s gene therapy pipeline to advance to clinical development.
The company cited the urgency of developing treatments, noting that patients can experience rapid vision loss from a very young age.