Ocuphire Pharma Investor Update slide image

Ocuphire Pharma Investor Update

RM 14 MIRA-3 Phase 3 Registration Trial Design Randomized, Double-Masked, Placebo-Controlled, Parallel, Multi-Center, One-Day Trial 16 US sites 368 subjects Screening 0.75% Nyxol 2 21 Placebo Randomization Mydriatic Agent A, B, or C Mydriasis -1 Hour Treatment (Max Dilation) 0 min Mydriatic Agent A, B, or C 1 Hr 30min Nyxol drop(s) (2 drops study eye, 1 drop fellow eye) Primary Endpoint 2 Hr 90min 3 Hr Placebo drop(s) (2 drops study eye, 1 drop fellow eye) 4 Hr Follow Up Visit MIRA-3 Started in Nov 2021 Enrolled 368 in Feb 2022 Phase 3 Results Reported March 2022 6 Hr 24 Hr Key Eligibility Criteria Inclusion: Healthy ≥ 12 years of age Exclusion: Clinically significant ocular trauma, surgery, or non-refractive laser treatment within the 6 months prior to screening; and recent or current evidence of ocular disease, infection or inflammation in either eye Mydriatic Agents 3:1:1-A: 2.5% phenylephrine (alpha-1 agonist), B: 1% tropicamide (cholinergic blocker), C: Paremyd® (combination) Endpoints Primary: % of subjects (study eye) returning to baseline (within 0.2 mm) pupil diameter (PD) at 90 min Key Secondary: % of subjects returning to baseline at Omin, 30min, 1h, 90 min 2h, 3h, 4h, 6h, 24h (overall, by mydriatic agent, by iris color) Mean time to return to baseline PD ● ● ● ● ● Mean change in pupil diameter at all timepoints Distance-Corrected Near Vision Accommodation (Tropicamide/Paremyd) Safety and tolerability Ocuphire PHARMA
View entire presentation