Opus Genetics banks FDA nod for presbyopia drop as Viatris payment falls due

Opus Genetics has secured a payment trigger from Viatris after the US Food and Drug Administration approved RYZUMVI (phentolamine ophthalmic solution 0.75%) for presbyopia in adults. The company disclosed the decision alongside its third-quarter 2026 results on 10 November. The approval came through a supplemental application, meaning it adds a new use to an already authorised product.

The size and timing of the Viatris milestone were not given in the material available to CompePharma, so its effect on Opus's near-term revenue cannot yet be gauged. Nor does the update say anything about pricing or launch plans for the new indication.

Opus ended the period with $89.0 million in cash, which it says is enough to finance operations into 2029. The company did not set out in the update how much of that figure, if any, depends on the Viatris payment.

The development pipeline moved on several fronts. The FDA allowed the investigational application for OPGx-RDH12, a candidate for Leber congenital amaurosis linked to RDH12 mutations, to proceed. Opus has also finished recruiting for its Phase 3 study of OPGx-LCA5, and has dosed all patients in the second cohort of its OPGx-BEST1 programme. Data from that cohort are expected in the first quarter of 2027.