Viatris Receives U.S. FDA Approval for RYZUMVI® for the Treatment of Presbyopia

A South African court ordered the Department of Health to reconsider a R15.5-billion ARV tender after finding irregularities. Cipla Medpro and Hetero Drugs challenged the awards, with Cipla successful in part. Judge Girdwood set aside awards for one-month and three-month drug packs, citing unlawful and unconstitutional practices. Innovata and Viatris were excluded from reconsideration. Current suppliers will continue deliveries to avoid shortages. The department has 120 days to redo the awards.

The FDA approved Viatris' Ryzumvi (phentolamine ophthalmic solution) for treating presbyopia, expanding its use. The approval follows successful phase 3 trials showing efficacy and safety. Opus Genetics, the drug's originator, reported positive results, with 27.2% of participants meeting primary endpoints. The drug offers a new option for presbyopia, a condition affecting 90% of adults over 45 in the US.

The FDA approved Viatris' Ryzumvi (phentolamine ophthalmic solution 0.75%) to treat presbyopia in adults. Viatris holds exclusive US rights under a global licensing agreement with Opus Genetics. The company is exploring commercial partnerships for nationwide distribution. Presbyopia affects nearly all adults over 40, causing vision-related disability. Clinical studies reported common side effects like conjunctival hyperaemia and instillation site irritation.

Viatris received FDA approval for RYZUMVI to treat presbyopia, but lacks a U.S. commercialization plan. The company is seeking a partner. Data from Phase 3 trials showed side effects like conjunctival hyperemia and irritation. Viatris holds U.S. rights via a licensing agreement with Opus Genetics.

Viatris Inc. (VTRS) received FDA approval for RYZUMVI to treat presbyopia in adults, expanding its use. The company is seeking a U.S. commercialization partner. VTRS shares closed at $18.66, up 2.39%.

FDA approved Opus Genetics' Ryzumvi (phentolamine ophthalmic solution 0.75%) for treating presbyopia in adults. The approval follows successful phase 3 trials. Viatris holds US commercialization rights. Common side effects include conjunctival hyperemia and instillation site irritation.