Ocuphire Pharma, Inc. announced that the FDA has accepted its new drug application (NDA) for phentolamine ophthalmic solution 0.75% for the treatment of pharmacologically-induced mydriasis.
This acceptance follows the company’s NDA submission to the FDA in December 2022.
Tell me more about Nyxol.
Nyxol is a preservative-free eye drop designed to be administered once a day to reduce pupil dilation in patients with three indications: dim light vision disturbances, presbyopia, and reversal of pharmacologically-induced mydriasis (RM).
The FDA previously granted a small business waiver of the Prescription Drug User Fee Act (PDUFA) for the NDA submission of Nyxol in September 2022.
How did it perform in clinical trials?
Nyxol has been assessed in 12 completed clinical trials. It showed a favorable safety and tolerability profile for RM across all studies.
See here for additional data.
Now what?
The FDA has designated September 28, 2023, as the PDUFA date. If approved, Nyxol for RM would become the first and only prescription reversal drop for patients in the U.S.