Ocuphire Pharma (NASDAQ:OCUP) filed an application to the U.S. Food and Drug Administration (FDA) seeking approval of eye drop Nyxol to reverse pharmacologically-induced mydriasis (dilation of pupil).
The company's new drug application (NDA) for Nyxol (Phentolamine Ophthalmic Solution 0.75%) is for the reversal of pharmacologically-induced mydriasis produced by adrenergic agonist (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents, or a combination.
"If approved, Nyxol is expected to be the only commercially available treatment option indicated for the reversal of dilated eyes," said Ocuphire Founder and CEO Mina Sooch.
The NDA was backed by data from the MIRA-1 phase 2b trial, MIRA-2 and MIRA-3 phase 3 studies, and MIRA-4 phase 3 pediatric trial.
Ocuphire has a license agreement for Nyxol with FamyGen Life Sciences, which is being acquired by Viatris (NASDAQ:VTRS).
