Benzinga | Mar 15, 2021 06:38AM EDT

Ocuphire Pharma Stock Is Trading Higher After Nyxol Aces Late-Stage Study

Ocuphire Pharma Inc (NASDAQ: OCUP) stock is soaring in the premarket in reaction to positive data from MIRA-2 Phase 3 trial evaluating Nyxol. Nyxol is an eye drop formulation of phentolamine mesylate designed to reverse pharmacologically induced mydriasis (dilation of pupil for eye exams).

* The study met its primary endpoint, with 49% of subjects treated with Nyxol returning to less than 0.2 mm of their baseline pupil diameter at 90 minutes compared to 7% of subjects treated with placebo.

* A higher number of Nyxol treated subjects returned to baseline pupil diameter at 60 minutes compared to placebo.

* Nyxol treated subjects had mean pupil diameters that were 1 to 2.5 mm smaller than placebo-treated subjects at all time points from 1 to 6 hours post-dosing.

* Nyxol treated subjects returned to baseline pupil diameter more quickly than placebo-treated subjects.

* The treatment was well-tolerated and demonstrated a favorable safety profile.

* The company plans to start a second Phase 3 trial in the second half of this year. FDA marketing application is expected to be submitted in early 2023.

* Full results from the MIRA-2 Phase 3 trial will be presented at an upcoming industry conference - 2021 ASCRS Annual Meeting July 23--27 in Las Vegas, Nevada.

* Price Action: OCUP gained 88.7% at $14.99 in premarket trading on the last check Monday.