IRD PDUFA Date: Phentolamine ophthalmic Updated August 19, 2026 ยท next FDA decision on the calendar FDA decision (PDUFA) target Oct 17, 2026 · Opus Genetics, Inc. · Presbyopia (sNDA)
Key facts FDA PDUFA target date 2026-10-17
Drug / candidate Phentolamine ophthalmic
Indication Presbyopia (sNDA)
Company Opus Genetics, Inc.
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See the full 2026 PDUFA calendar → All October 2026 PDUFA dates → FAQ When is the IRD PDUFA date? The FDA PDUFA target date for IRD (Opus Genetics, Inc.) is 2026-10-17 for Phentolamine ophthalmic. Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is IRD's drug Phentolamine ophthalmic? Phentolamine ophthalmic is Opus Genetics, Inc.'s candidate under FDA review for Presbyopia (sNDA).
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