Opus Genetics' OPGx-LCA5 Program Accepted Into FDA's Rare Disease Evidence Principles Program

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 its investigational LCA5 gene therapy program, OPGx-LCA5, has been accepted into the U.S. Food and Drug Administration's (FDA) Rare Disease Evidence Principles (RDEP) program.

OPGx-LCA5 is a potential gene therapy for Leber congenital amaurosis type 5 (LCA5), a rare inherited retinal disease caused by mutations in the LCA5 gene. The condition leads to early-onset, progressive vision loss and often results in severe visual impairment or blindness in childhood. There are currently no approved therapies specifically targeting LCA5.