OCUP - Ocuphire Pharma launches late-stage study of Nyxol in night vision disturbances

Ocuphire Pharma (OCUP) has initiated patient recruitment and screening in late December for its LYNX-1 Phase 3 registration study evaluating the safety and efficacy of Nyxol in night vision disturbances ((NVD)) in U.S. Patients with NVD experience glare, halos, starbursts and decreased contrast sensitivity. The Phase 3 trial is expected to enroll 160 patients in U.S. Patients will be randomized to receive either Nyxol or placebo administered in each eye daily over 14 days.The primary endpoint is the percentage of subjects with at least 3 lines of improvement in mesopic, low-contrast, best-corrected distance visual acuity after 7 days.Secondary endpoints include pupil diameter reductions, other visual acuity measures (distance and near), and safety and tolerability.LYNX-1 is the first of two registration trials planned for Nyxol in this chronic indication prior to a NDA submission.

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Ocuphire Pharma launches late-stage study of Nyxol in night vision disturbances