■ Ocuphire Pharma has submitted its NDA for phentolamine ophthalmic solution 0.75%, brand name Nyxol, to be used for the reversal of pharmacologically induced mydriasis. The company stated that the NDA is supported by positive results from the comprehensive MIRA clinical program involving more than 600 subjects.

“If approved, Nyxol is expected to be the only commercially available treatment,” Mina Sooch, MBA, founder, and CEO of Ocuphire Pharma, said in a company news release.

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. The positive MIRA-4 pediatric trial results support a potential broader label for Nyxol in the reversal of mydriasis for pediatric patients aged 3 and older, the news release stated.