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Ocuphire Pharma Results

ZETA-1 Phase 2b Design for DR/DME Ongoing, Randomized, Double-Masked, Placebo-Controlled 24-Week Trial (Similar To Eylea P3 DR Trial) 25 US sites 90-100 participants with moderately severe to severe NPDR or mild PDR Noncentral DME is permitted Eligibility Screening Ocuphire 1:1 PHARMA Randomization Week 0 APX3330 600 mg/day (BID) Primary Endpoint Week 4 Week 12 Enrollment of 103 DR Patients Completed (Apr 2021 to Mar 2022) Top Line Data Expected in Q4 2022 Placebo BID NPDR = non-proliferative diabetic retinopathy (which includes non centrally involved diabetic macular edema) PDR = proliferative diabetic retinopathy (which includes non centrally involved diabetic macular edema) ZETA-1 Clinical Trial is Sponsored by Ocuphire Pharma https://clinicaltrials.gov/ct2/show/NCT04692688?term=ZETA-1&draw=2&rank=1 Week 24 Endpoints Primary: % of subjects with a ≥2 step improvement on the DRSS (Diabetic Retinopathy Severity Scale) score at week 24 Secondary: Central subfield thickness (CST) BCDVA (ETDRS) ● ● ● ● ● DRSS change at week 12 Rescue subjects Safety and tolerability Exploratory: Labs / PK 41
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