OCUP - Ocuphire gets FDA fee waiver over marketing application for eye therapy
- Ocuphire Pharma ( NASDAQ: OCUP ), a clinical-stage biopharma company focused on eye diseases, announced Monday that the FDA granted a waiver in connection with the Prescription Drug User Fee Act (PDUFA) fee of $3.1M for its New Drug Application (NDA) for ophthalmic solution Nyxol.
- Nyxol, OCUP’s lead candidate, has undergone multiple clinical studies, including registrational trials for the reversal of pharmacologically-induced mydriasis (RM).
- OCUP expects to file an NDA in late 2022 for Nyxol in RM while continuing to discuss with partners as the company prepares for its commercial activities in anticipation of the FDA approval and market launch in 2023.
- “We are pleased to receive this meaningful NDA fee waiver for Nyxol and look forward to continuing to work with the FDA throughout the submission and review process,” Chief Executive Mina Sooch remarked.
- Read about data from a second Phase 3 trial for Nyxol in RM, which met its main goal.
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Ocuphire gets FDA fee waiver over marketing application for eye therapy