Ocuphire Pharma announces FDA acceptance of NDA for Nyxol

Ocuphire Pharma announced that the U.S. Food and Drug Administration, FDA, has accepted the New Drug Application, NDA, for Nyxol for the treatment of pharmacologically-induced mydriasis, RM. The FDA assigned a Prescription Drug User Fee Act, PDUFA, date of September 28, 2023. "The FDA’s acceptance of the NDA submission and PDUFA date in late September for Nyxol sets the stage for an exciting 2023", said Mina Sooch, MBA, founder and CEO of Ocuphire Pharma. "We look forward to working closely with the FDA during the review process. If approved later this year, Nyxol eye drops will be the first prescription reversal drop available for patients in the US. In addition, we look forward to leveraging the synergies of this first NDA for Nyxol in potential supplementary NDAs for presbyopia and dim light vision disturbances indications in the future." The NDA filing is supported by positive results from the comprehensive MIRA clinical program collectively involving over 600 subjects, including the MIRA-1 Phase 2b trial, MIRA-2 and MIRA-3 Phase 3 pivotal trials, and MIRA-4 Phase 3 pediatric trial.