OCUP - Ocuphire rises as eye therapy goes under FDA review
- Ocuphire Pharma ( NASDAQ: OCUP ) gained ~9% pre-market Monday after announcing that the FDA accepted its marketing application for Nyxol, a treatment targeted at reversing pharmacologically induced eye dilations.
- The FDA has assigned September 28, 2023, as the action date to review the New Drug Application (NDA).
- The treatment is an investigational eye drop formulation of phentolamine ophthalmic solution 0.75% targeted at pharmacologically induced mydriasis as well as night vision disturbances.
- According to the company, pharmacologically induced pupil dilation is a routine procedure in eye check-ups, even though there are no FDA-approved therapies to reverse the condition.
- Ocuphire ( OCUP ) supports the NDA with data from MIRA-2 and MIRA-3 Phase 3 pivotal trials and MIRA-4 Phase 3 pediatric trial, which it expects would lead to a broader label.
- Viatris ( VTRS ) has a partnership with drug development company FamyGen Life Sciences to commercialize Nyxol once approved.
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Ocuphire rises as eye therapy goes under FDA review