FDA accepts NDA, sets PDUFA date for Ocuphire Pharma’s mydriasis treatment

The NDA filing is supported by positive results from the comprehensive MIRA clinical program collectively involving 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.

Ocuphire Pharma Inc. today announced the FDA has accepted the New Drug Application (NDA) for phentolamine ophthalmic solution 0.75% (Nyxol) for the treatment of pharmacologically-induced mydriasis (RM).

The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of September 28, 2023.

In a news release, Mina Sooch, MBA, founder and CEO of Ocuphire Pharma, the FDA’s acceptance of the NDA submission and PDUFA date in late September for ophthalmic solution 0.75% sets the stage for an exciting 2023 for the company.

“We look forward to working closely with the FDA during the review process,” Sooch said in a statement. “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.”

Phentolamine ophthalmic solution 0.75% designed to uniquely modulate the pupil size by blocking the α1 receptors found only on the iris dilator muscle without affecting the ciliary muscle. It is being developed for reversal of pharmacologically-induced mydriasis (RM), presbyopia, and dim light (night) vision disturbances (DLD) under the 505(b)(2) pathway.

Paul Karpecki, OD, clinical director of cornea at the Kentucky Eye Institute, noted that phentolamine ophthalmic solution 0.75% could prove to enhance the patient experience.

“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,” Karpecki said. “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.”

According to the news release, the NDA filing is supported by positive results from the comprehensive MIRA clinical program collectively involving 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 MIRA-2 and MIRA-3 trials successfully met their primary and key secondary endpoints, demonstrating statistically significant superiority of phentolamine ophthalmic solution 0.75% compared to placebo to rapidly return dilated eyes to their baseline pupil diameter as early as 60 and 90 minutes. Phentolamine ophthalmic solution 0.75% consistently showed a favorable safety and tolerability profile across all trials. In addition, the positive MIRA-4 pediatric trial results support a potential broader label for the solution in RM to include subjects aged 3 and older.