Opus Genetics announces FDA acceptance of supplemental new drug application for phentolamine ophthalmic solution 0.75% for the treatment of presbyopia

Opus Genetics

25 February 2026 - Opus Genetics  today announced that the US FDA has accepted for review the supplemental new drug application for phentolamine ophthalmic solution 0.75% for the treatment of presbyopia. 

The FDA has assigned a PDUFA goal date of 17 October 2026.

Read Opus Genetics press release

Michael Wonder

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Michael Wonder

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Medicine , US , Regulation , Dossier