Ocuphire's Nightblindness Candidate Meets Primary Endpoint In Phase 3 Study

Ocuphire Pharma Inc OCUP has announced topline results from the LYNX-1 Phase 3 trial investigating Nyxol for night (or dim light) vision disturbances (NVD).

• The FDA-agreed primary endpoint was met, with a statistically significant greater percentage of Nyxol-treated subjects having gained 15 or more letters of mesopic low contrast distance visual acuity (mLCVA) at Day 8, compared to placebo (13% vs. 3%).
• Related: Ocuphire Pharma's Shares Fall Despite Positive Data From Registrational Phase 3 Trial Of Nyxol.
• The effect of Nyxol increased at Day 15, with 21% of subjects gaining 15 or more letters of mLCVA compared to 3% placebo.
• Nyxol significantly increased the percentage of subjects gaining 10 or more letters of mLCVA at both Day 8 with 41% vs. 22% placebo and at Day 15 with 44% vs. 23%.
• Nyxol showed a favorable safety and tolerability profile. There were no serious adverse events, and adverse events in Nyxol-treated subjects were predominantly mild.
• Price Action: OCUP shares are down 8.25% at $1.95 during the market session on the last check Thursday.