Ocuphire Pharma Investor Update
RM
26
Summary of Positive MIRA-3 Phase 3 Results for Nyxol Eye Drops
Confirms Prior Phase 3 Study Showing Substantial Benefit in Accelerating Reversal of Mydriasis
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Met primary endpoint at 90 minutes with 58% of subjects returning to pre-dilation
pupil diameter vs. 6% of placebo treated subjects (p < 0.0001)
Saving of ~4 hours in time to return to normal pupil diameter
Met key secondary endpoints with high statistical significance
Efficacy seen at all timepoints from 60 minutes to 24 hours
Similar efficacy for one drop and two drops
Efficacy across all 3 mydriatic agents - phenylephrine, tropicamide, and ParemydⓇ
Efficacy in both light and dark iris colors
Accelerated return to normal distance-corrected near visual acuity
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Favorable safety and tolerability profile
No serious AEs, no drop-outs from AEs
No systemic or ocular AEs were observed in ≥ 5% of subjects, except for 11% mild, transient conjunctival
hyperemia
NDA planned for late 2022
MIRA-3 Topline Reports
Ocuphire
PHARMAView entire presentation