Ocuphire Announces MIRA-2 Phase 3 Registration Trial for the Reversal of Mydriasis Meets Primary Endpoint - Seite 2

Highlights of MIRA-2 Topline Efficacy and Safety Results

MIRA-2 (NCT04620213) is a Phase 3 registration trial evaluating the product candidate Nyxol to expedite the reversal of pharmacologically induced mydriasis. In the trial 185 study participants (171 adults and 14 adolescents at or over age 12) were randomized 1:1 to receive Nyxol (0.75% phentolamine ophthalmic solution) or vehicle control (placebo) 1 hour after receiving one of 3 mydriatic agents.

• The primary endpoint was met with 49% percent of subjects (study eye) treated with Nyxol returning to ≤ 0.2 mm of their baseline pupil diameter at 90 minutes compared to 7% of placebo treated subjects (p <0.0001) across three mydriatic agents (phenylephrine, tropicamide, and Paremyd).
  • Multiple secondary efficacy endpoints also met statistical significance.
  • A clinically meaningful higher number of Nyxol treated subjects (study eye and non-study eye) returned to baseline pupil diameter at 60 minutes compared to placebo, and every subsequent timepoint through 6 hours post-dosing.
  • Nyxol treated subjects had mean pupil diameters that were 1 to 2.5 mm smaller than placebo treated subjects at all timepoints from 1 to 6 hours post-dosing.
  • Nyxol treated subjects returned to baseline pupil diameter more quickly than placebo treated subjects with:
  (i) all three dilating agents;
  (ii) both light and dark irides; and
  (iii) with one and two drops of Nyxol.

• Nyxol demonstrated a favorable safety profile.
  • Nyxol was well-tolerated in the study population with no serious adverse events or withdrawals due to adverse events.
  • A mild transient increase in conjunctival hyperemia was observed in Nyxol treated subjects which peaked at one hour post-dose and decreased steadily thereafter.
  

Jay S. Pepose, MD, PhD, Director of the Pepose Vision Institute, Professor of Clinical Ophthalmology at the Washington University School of Medicine, and Ocuphire Medical Advisory Board member commented, “I am excited to see robust effects of Nyxol in reversing pharmacologically induced mydriasis with a favorable safety profile. The Phase 3 trial results exceeded my expectations with statistical and clinical significance on the primary endpoint at 90 minutes, as well as at the earlier 60 minute timepoint. In addition, Nyxol demonstrated significant benefit through 6 hours across the range of commonly used mydriatic agents, light and dark iris colors, and age cohorts. Nyxol is unique as the only alpha-1/2 antagonist in clinical trials. Nyxol has the potential to address an unmet medical need as there are no commercial treatments currently available for reversal of mydriasis. If approved for marketing by the FDA, Nyxol may provide substantial benefit to patients after dilation, and may even increase the compliance with standard of care guidance for dilated examinations during visits to eye care specialists and thereby improve overall eye health.”