Ocuphire Pharma Results Presentation Deck
RM
20
Next Steps For Nyxol RM Indication for NDA
NDA Submission Expected Early 2023
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Perform a second Phase 3 RM registration trial (MIRA-3)
Planned 330 subjects randomized 2:1 to Nyxol or Placebo
In addition to confirming efficacy, this trial will satisfy the regulatory requirement for number of subjects
(300 or more) exposed for approval for acute use (24 hours)
Limited pharmacokinetic sampling will be obtained in a small subset of subjects
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Results anticipated 1Q2022
Perform a small (20-30 subjects) pediatric RM trial (age 3 - 17 years) to satisfy pediatric
research plan regulatory requirement
• Manufacture and complete one-year stability on three registration batches for Nyxol
single unit dose Blow-Fill-Seal vials
Proposed Indication
The treatment of pharmacologically induced mydriasis produced by adrenergic (e.g.
phenylephrine) or parasympatholytic (e.g. tropicamide) agents, or a combination thereof.
Nyxol End of Phase 2 FDA Meeting minutes
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