Phentolamine ophthalmic solution 0.75%, or Nyxol, receives a PDUFA date of September 28, 2023, for the indication of reversal of pharmacologically induced mydrasis.
On February 13, Ocuphire Pharma announced that their New Drug Application (NDA) for phentolamine ophthalmic solution 0.75% (Nyxol) for the reversal of pharmacolologically induced mydriasis (RM) has been accepted by the U.S. Food and Drug Administration (FDA). The company also shared that the FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of September 28, 2023.1
“The FDA’s acceptance of the NDA submission and PDUFA date in late September for Nyxol sets the stage for an exciting 2023,” Mina Sooch, MBA, founder and CEO of Ocuphire Pharma, said in a press release. “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 for RM was filed in December of 2022 based on the results from the MIRA clinical program. MIRA-2 and MIRA-3 phase 3 pivotal trials met both primary and key secondary endpoints, and the data were included in the NDA submission due to the statistically significant superiority of phentolamine compared to placebo. Across the clinical program, phentolamine showed favorable safety and tolerability profiles.
The reversal is produced by an adrenergic agonist (phenylephrine), parasympatholytic agents (tropicamide), or a combination of the two. Phentolamine ophthalmic solution 0.75% rapidly returns dilated eyes to baseline pupil diameter as soon as 60 and 90 minutes from dilation.
Additionally, the MIRA-4 phase 3 pediatric trial supports a broader label for phentolamine ophthalmic solution 0.75% in RM to include patients aged 3 and older.
Phentolamine ophthalmic solution 0.75% for RM is one of 3 indications for which Nyxol is being investigated. In November 2022, Ocuphire Pharma announced plans to enter an exclusive license agreement with FamyGen Life Sciences for the development and commercialization of Nyxol for RM, presbyopia, and night vision disturbances.