The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Nyxol® (phentolamine ophthalmic solution 0.75%) for the reversal of pharmacologically-induced mydriasis.
Nyxol is a preservative-free eye drop formulation of phentolamine mesylate, a nonselective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size. The NDA is supported by data from the MIRA clinical program, which included the phase 3 MIRA-2 (ClinicalTrials.gov Identifier: NCT04620213) and MIRA-3 (ClinicalTrials.gov Identifier: NCT05134974) trials.
The randomized, placebo-controlled MIRA-2 (n=185) and MIRA-3 (n=368) trials evaluated the efficacy and safety of Nyxol in patients 12 years of age and older with pharmacologically-induced mydriasis. Patients were randomly assigned to receive either 2 drops of Nyxol or placebo in the study eye and 1 drop in the non-study eye, 1 hour post pharmacologically-induced mydriasis.
The primary endpoint was the percentage of patients’ study eyes with pupil diameter returning to less than or equal to 0.2mm from baseline. In both trials, Nyxol met the primary and key secondary endpoints demonstrating statistically significant superiority over placebo, with pupil diameter rapidly returning to baseline diameter as early as 60 and 90 minutes.
The submission also includes data from the phase 3 MIRA-4 trial (ClinicalTrials.gov Identifier: NCT05223478), which evaluated Nyxol in pediatric patients 3 to 11 years of age with pharmacologically-induced mydriasis. Findings showed Nyxol rapidly reversed mydriasis and demonstrated a favorable safety profile in pediatric patients.
A Prescription Drug User Fee Act target date of September 28, 2023 has been set for the application. “If approved later this year, Nyxol eye drops will be the first prescription reversal drop available for patients in the US,” said Mina Sooch, MBA, founder and CEO of Ocuphire Pharma.
Nyxol is also being evaluated as a treatment for presbyopia and dim light (night) vision disturbances.
- Ocuphire announces FDA acceptance of New Drug Application and PDUFA date of September 28, 2023 for Nyxol® Eye Drops for reversal of mydriasis. News release. Ocuphire Pharma, Inc. Accessed February 13, 2023. https://www.globenewswire.com/news-release/2023/02/13/2606587/0/en/Ocuphire-Announces-FDA-Acceptance-of-New-Drug-Application-and-PDUFA-Date-of-September-28-2023-for-Nyxol-Eye-Drops-for-Reversal-of-Mydriasis.html.
- Ocuphire completes last clinical trial supporting the planned 2022 NDA submission with the announcement of positive results from MIRA-4 pediatric safety trial evaluating Nyxol® for reversal of mydriasis. News release. Ocuphire Pharma, Inc. April 28, 2022. Accessed February 13, 2023. https://www.ocuphire.com/news-media/press-releases/detail/371/ocuphire-completes-last-clinical-trial-supporting-the.