Nyxol filed with FDA for mydriasis
Ocuphire Pharma announced that the FDA has accepted the New Drug Application (NDA) for Nyxol (phentolamine ophthalmic solution 0.75%) for the treatment of pharmacologically-induced mydriasis (RM)
The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of September 28, 2023.
The NDA filing is supported by positive results from the comprehensive MIRA clinical program collectively involving over 600 subjects, including the MIRA-1 Phase IIb trial, MIRA-2 and MIRA-3 Phase III pivotal trials, and MIRA-4 Phase III pediatric trial. The MIRA-2 and MIRA-3 trials successfully met their primary and key secondary endpoints, demonstrating statistically significant superiority of Nyxol compared to placebo to rapidly return dilated eyes to their baseline pupil diameter as early as 60 and 90 minutes. Nyxol consistently showed a favorable safety and tolerability profile across all trials. In addition, the positive MIRA-4 pediatric trial results support a potential broader label for Nyxol in RM to include subjects aged 3 and older.
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