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®).
• 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.
