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
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Mean change in pupil diameter at
all timepoints
Distance-Corrected Near Vision
Accommodation
(Tropicamide/Paremyd)
Safety and tolerability
Ocuphire
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