Ocuphire Pharma Investor Update slide image

Ocuphire Pharma Investor Update

RM NDA Submission Targeted in Late 2022 Potential Regulatory Approval in 2023 29 Target Label Indication The treatment of pharmacologically induced mydriasis produced by adrenergic (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents, or a combination thereof. Preservative-Free Single Unit Vial (5-pack) AAAAA 3000 NyxolⓇ P3 Clinical Trial Completed 2nd Phase 3 trial in RM (enrolled 368 subjects), which also meets 24-hour safety population exposure requirement Ongoing 4141 Pediatric Safety Enrolled 23 subjects ages 3 to 11 per agreed FDA initial pediatric study plan Ongoing Manufacturing Completed 3 registration batches; 1-year CMC stability will be available for NDA Regulatory Approval Submit NDA by late 2022, with expected approval review of 10 months Ocuphire PHARMA
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