OCUP - Enrollment underway in Ocuphire's second Phase 3 Nyxol trial in reversal of mydriasis

Ocuphire Pharma (NASDAQ:OCUP) announces that the first subjects have been enrolled in the MIRA-3 Phase 3 pivotal trial evaluating Nyxol Eye Drops in the reversal of pharmacologically-induced mydriasis (dilation of the pupil). Shares down 5.3% premarket at $3.22. Top-line results are expected in early 2022, around the end of Q1. The MIRA-3 trial is designed to enroll approx. 330 subjects aged 12 and older. The primary efficacy endpoint is the percentage of subjects’ study eyes returning to ? 0.2 mm from baseline photopic pupil diameter at 90 minutes. Secondary endpoints include pupil diameter (at multiple time points from 30 minutes to 24 hours), accommodation, and a patient questionnaire, as well as new assessments of glare disability, glare tolerability, and pupillary response to light. Ocuphire is currently evaluating partnering options for an efficient and effective commercial launch of Nyxol targeted for H2 2023.

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Enrollment underway in Ocuphire's second Phase 3 Nyxol trial in reversal of mydriasis