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Ocuphire files for FDA approval of eye drop Nyxol

  • 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).
  • OCUP -6.83% to $3 premarket Dec. 6