Ocuphire Pharma's Shares Fall Despite Positive Data From Registrational Phase 3 Trial Of Nyxol

  • Ocuphire Pharma Inc OCUP announced topline results from the second Phase 3 MIRA-3 trial of Nyxol to reverse pharmacologically-induced mydriasis (dilation of the pupil). 
  • The trial met its primary endpoint, with 58% of subjects (study eye) treated with Nyxol returning to ≤ 0.2 mm of their baseline pupil diameter (PD) at 90 minutes compared to only 6% of subjects (study eye) treated with placebo. 
  • The effect was also significant at 60 minutes (Nyxol 42% vs. placebo 2%. 
  • Only 36% of placebo-treated subjects returned to baseline PD at 6 hours.
  • Ocuphire Pharma intends to file a marketing application with the FDA in late 2022, which, if approved, would position Ocuphire for a commercial launch of Nyxol in RM in 2H of 2023. 
  • Nyxol demonstrated a favorable safety and tolerability profile. The only AE occurring in greater than 5% of subjects was mild, transient conjunctival hyperemia (11%)
  • Ocuphire recently completed enrollment of 23 pediatric subjects in the MIRA-4 trial evaluating Nyxol eye drops to reverse pharmacologically-induced mydriasis. 
  • Topline results are expected in Q2 of 2022. If MIRA-4 meets its endpoints, the results would potentially support a broader label for Nyxol in RM to include children as young as age 3. 
  • Price Action: OCUP shares are down 16.60% at $3.55 during the market session on the last check Tuesday.
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