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IRD PDUFA Date: Phentolamine ophthalmic

Updated ยทnext FDA decision on the calendar
FDA decision (PDUFA) target Oct 17, 2026 · Opus Genetics, Inc. · Presbyopia (sNDA)
Primary source: sponsor announcement

Key facts

FDA PDUFA target date2026-10-17
Drug / candidatePhentolamine ophthalmic
IndicationPresbyopia (sNDA)
CompanyOpus Genetics, Inc.

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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).