OCUP - Ocuphire says main goal met for Nyxol late-stage trial for night vision disturbances

Ocuphire Pharma (NASDAQ:OCUP), a clinical-stage biotech focused on eye diseases, announced on Thursday that its Phase 3 pivotal clinical trial for Nyxol met the FDA-agreed primary endpoint in patients with the night (or dim light) vision disturbances (NVD). According to the topline data, the 145-patient trial named LYNX-1 met the main goal as more patients treated with Nyxol gained 3 lines of low contrast distance vision under dim light conditions compared to placebo. After 14 days of self-administered therapy, 13% of Nyxol-treated subjects gained 15 or more letters of mesopic low contrast distance visual acuity (mLCVA) at Day 8 with statistical significance compared to 3% in the placebo group. The trial also reached key secondary efficacy endpoints with statistical significance, including 21% of Nyxol-treated patients achieving 15 or more letters of mLCVA compared to 3% of placebo at Day 15. Nyxol was found to have a favorable safety and tolerability

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Ocuphire says main goal met for Nyxol late-stage trial for night vision disturbances