Abeona Therapeutics announces ABO-503 gene therapy for XLRS selected by FDA

Abeona Therapeutics (ABEO) announced that its ABO-503 gene therapy for X-linked retinoschisis, XLRS, has been selected to participate in the U.S. Food and Drug Administration, FDA, Rare Disease Endpoint Advancement, RDEA, Pilot Program. As part of the RDEA program, Abeona will have opportunities for enhanced communication and collaboration with the FDA, including frequent advice and regular ad-hoc conversations to accelerate the development and validation of product-specific novel efficacy endpoints for Abeona’s XLRS program. “XLRS is an underserved area with a large unmet need,” said Vish Seshadri, Chief Executive Officer of Abeona. “We are honored that ABO-503 gene therapy for XLRS has been chosen for the FDA’s highly competitive RDEA pilot program. We believe our participation will meaningfully improve the success rate of our XLRS clinical development efforts, and more broadly, could help facilitate pipeline innovation by using novel efficacy endpoints in new therapy development across other inherited retinal diseases.”