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# Ocuphire Pharma NDA for Eye Dilation Reversal
- URL: https://www.fdaweb.com/ocuphire-pharma-nda-for-eye-dilation-reversal/
- Published: 2023-02-13T12:00:00.000Z
- Updated: 2026-09-14T18:15:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153761

FDA has accepted for review an Ocuphire Pharma NDA for Nyxol (phentolamine ophthalmic solution 0.75%) for treating pharmacologically-induced mydriasis. The company says patients often are troubled by the effects of prolonged eye dilation, and a reversal drop would significantly improve patient experiences and productivity. The agency has set a user fee review action target date of 9/28.

The submission is based on data from the MIRA clinical program that included over 600 subjects. “The MIRA-2 and MIRA-3 trials successfully met their primary and key secondary endpoints, demonstrating statistically significant superiority of Nyxol compared to placebo to rapidly return dilated eyes to their baseline pupil diameter as early as 60 and 90 minutes,” Ocuphire says. “Nyxol consistently showed a favorable safety and tolerability profile across all trials.”

Nyxol is designed to modulate the pupil size by blocking the α1 receptors found only on the iris dilator muscle without affecting the ciliary muscle, the company says.