Opus Genetics (IRD) announced that the U.S. Food and Drug Administration, FDA, has granted Regenerative Medicine Advanced Therapy, RMAT, designation to OPGx-LCA5, its investigational gene therapy for the treatment of Leber Congenital Amaurosis, LCA, due to genetic variations in the LCA5 gene. “The FDA’s decision to grant RMAT designation to OPGx-LCA5 is a major milestone for the LCA5 patient community and a strong validation of our early clinical data,” said George Magrath, M.D., Chief Executive Officer, Opus Genetics. “We’re encouraged by the potential of OPGx-LCA5 to meaningfully impact patients living with this ultra-rare and debilitating form of inherited blindness, and we look forward to continued collaboration with the FDA to accelerate its development.”
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