Ocuphire Announces MIRA-2 Phase 3 Registration Trial for the Reversal of Mydriasis Meets Primary Endpoint

Nyxol Meets Its Primary and Multiple Secondary Endpoints Including Statistically Significant Efficacy Returning Subjects More Rapidly to Normal Pupil Size Across a Breadth of Dilating Agents and Iris Colors

Nyxol has Potential to be a New Treatment Option for Reversal of Pharmacologically-Induced Pupil Dilation

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FARMINGTON HILLS, Mich., March 15, 2021 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders, today announced positive top line results in the MIRA-2 Phase 3 registration trial investigating its product candidate Nyxol for reversal of pharmacologically induced mydriasis (dilation of pupil for eye exams). 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. MIRA-2 was designed as a multi-center, randomized, double-masked, placebo-controlled, parallel, 24-hour Phase 3 trial that planned 168 healthy study participants, and ultimately enrolled 185 study participants.

These topline results indicate that the MIRA-2 trial met its primary endpoint with 49% percent of subjects (study eye) treated with Nyxol returning to ≤ 0.2 mm of their baseline pupil diameter at 90 minutes compared to 7% of subjects (study eye) treated with placebo (p <0.0001). The study population was comprised of subjects who had received one of three mydriatic (dilating) agents in the modified Intent to Treat population (mITT). The three mydriatic agents used in this trial were phenylephrine 2.5% (alpha 1 agonist works on the iris dilator muscle), tropicamide 1% (cholinergic blocker works on the iris sphincter muscle), and Paremyd (a combination of hydroxyamphetamine hydrobromide 1% and tropicamide 0.25%), which are all commonly used in optometry and ophthalmology offices to dilate patients’ pupils for annual or special exams.

“The successful outcome of this Phase 3 MIRA-2 FDA registration trial is a major milestone for Ocuphire and we are thrilled to announce these positive and clinically meaningful results. Nyxol showed a statistically significant improvement on the primary as well as multiple secondary endpoints, demonstrating its ability to more rapidly return pupil diameter back to normal baselines over multiple timepoints, breadth of iris colors, and dilating agents that work on one or both iris muscles that control pupil size,” said Mina Sooch, MBA, President and CEO of Ocuphire Pharma. “These Phase 3 results build on a growing body of evidence to establish Nyxol’s therapeutic product profile including the positive results seen in our recently published MIRA-1 Phase 2b trial. This further validates the mechanism of action, therapeutic effect, and safety profile of the Nyxol platform for potential additional refractive indications - presbyopia and night vision disturbance. We are very grateful to the study participants and investigators who participated in this U.S. study.”