Ocuphire's Nyxol MIRA-3 Phase 3 Trial Meets Primary Endpoint In Reversal Of Mydriasis

(RTTNews) - Ocuphire Pharma, Inc. (OCUP), a clinical-stage ophthalmic biopharmaceutical company, announced Tuesday positive topline results in the MIRA-3 FDA Registration trial for Nyxol for the reversal of pharmacologically-induced mydriasis, i.e., dilation of pupil.

The company plans to file an NDA that includes the results of MIRA-1, MIRA-2, MIRA-3, and MIRA-4 with the U.S. FDA in late 2022.

Ocuphire expects commercial launch of Nyxol in RM to be in the second half of 2023.

Nyxol is a proprietary, preservative-free, stable, investigational eye drop formulation of phentolamine mesylate designed to reduce pupil size by inhibiting contraction of the iris dilator muscle.

The company said its second Phase 3 registration trial investigating its product candidate Nyxol met its primary endpoint. In the trial, 58% of subjects treated with Nyxol returning to = 0.2 mm of their baseline pupil diameter at 90 minutes compared to only 6% of subjects treated with placebo.

MIRA-3 enrolled 368 subjects from November 2021 to February 2022 at 16 sites in the U.S.

Ocuphire announced positive results from its first Phase 3 trial, MIRA-2, in March 2021.

Ocuphire recently completed enrollment of 23 pediatric subjects in the MIRA-4 trial evaluating the safety and efficacy of Nyxol eye drops to reverse pharmacologically-induced mydriasis.

Top line results are expected in the second quarter of 2022.

Mina Sooch, President and CEO of Ocuphire Pharma, said, "We now have over 900 subjects studied across 10 clinical trials of which over 550 have been exposed to Nyxol. Importantly, today's announcement means that that we have two FDA registration trials to support potential approval for the RM indication. We intend to file an NDA with the U.S. FDA in late 2022, which, if approved, would position Ocuphire for commercial launch of Nyxol in RM in the second half of 2023."