Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
Phentolamine ophthalmic is an Opus Genetics, Inc. program in presbyopia (sNDA). Its PDUFA date is Oct 17, 2026, the FDA's goal date to complete review of the application. Every date links its source.
Indication under review: Presbyopia (sNDA). Sponsor: Opus Genetics, Inc. (IRD). Review status: sNDA accepted; PDUFA goal date Oct 17, 2026 Market-cap tier at the time we tracked it: Small. We track 1 catalyst event for this program: 1 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
When is Phentolamine ophthalmic's next FDA decision or readout?
Phentolamine ophthalmic's PDUFA date is Oct 17, 2026. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
What happened at Phentolamine ophthalmic's most recent FDA decision?
No FDA decision for Phentolamine ophthalmic is in our archive yet.
What is Phentolamine ophthalmic used for?
In our records Phentolamine ophthalmic is under review or in development for Presbyopia (sNDA).
Who makes Phentolamine ophthalmic?
Opus Genetics, Inc. (IRD).
Where does this data come from?
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
and company filings. pdufa.bio is not affiliated with the FDA.
Not affiliated with or endorsed by the FDA. pdufa.bio is an independent publication with no affiliation with, endorsement by, sponsorship by, or connection to the U.S. Food and Drug Administration or any other government agency. “FDA”, “PDUFA” and all company, drug and ticker names are used descriptively and remain the property of their respective owners.
Informational and educational purposes only. Not investment advice. Nothing on this page is investment, legal, tax or medical advice, or an offer or solicitation to buy or sell any security. pdufa.bio is not a registered investment adviser or broker-dealer and does not recommend trades or publish individual-drug approval probabilities. Verify every date and outcome against primary FDA, SEC or company filings. Data is provided as is, without warranty of any kind, and past behaviour does not predict future outcomes.