The FDA assigned a PDUFA date of September 28, 2023 for the phentolamine ophthalmic solution 0.75%.
The New Drug Application (NDA) for phentolamine ophthalmic solution 0.75% (Nyxol®) has been accepted by the US Food and Drug Administration (FDA) for the treatment of pharmacologically induced mydriasis.1
As announced in a release by Ocuphire Pharma, the FDA has assigned the ophthalmic solution a Prescription Drug User Fee Act (PDUFA) date of September 28, 2023.
“Over 100 million eye dilations are performed each year in the US in pediatric and adult patients, and we expect dilations, which are the standard of care for comprehensive eye exams, to increase due to an aging population,” said Paul Karpecki, Clinical Director of Cornea at Kentucky Eye Institute in the release. “Patients often express frustration and discomfort with the effects of prolonged dilation and eye care professionals underestimate the time it takes for patients to return to normal pupil size. A reversal drop would significantly improve patient experience and productivity.”
The therapy is a proprietary, preservative-free, stable, investigational eye drop formulation of phentolamine ophthalmic solution 0.75% designed to modulate pupil size by blocking the α1 receptors found only on the iris dilator muscle without affecting the ciliary muscle. It was developed for the reversal of pharmacologically induced mydriasis as well as presbyopia and dim light vision disturbances under the 505(b)(2) pathway.
The NDA filing for the ophthalmic solution was supported by positive results from the MIRA clinical program encompassing over 600 subjects, including the MIRA-1 Phase 2b trial, MIRA-2 and MIRA-3 Phase 3 pivotal trials, and MIRA-4 Phase 3 pediatric trial. The findings from the MIRA-2 and MIRA-3 trials reported they successfully met their primary and key secondary endpoints.
Each trial demonstrated statistically significant superiority of phentolamine ophthalmic solution 0.75% compared to placebo to rapidly return dilated eyes to their baseline pupil diabetes as early as 60 and 90 minutes. The solution showed consistent favorable safety and tolerability across all trials. The release noted the positive MIRA-4 trial results supported a potential broader label pharmacologically-induced mydriasis to include subjects aged 3 years and older.
“The FDA’s acceptance of the NDA submission and PDUFA date in late September for Nyxol sets the stage for an exciting 2023,” said Mina Sooch, MBA, founder and CEO of Ocuphire Pharma in the 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.”