FDA approves Viatris’ Ryzumvi for adult presbyopia

The U.S. Food and Drug Administration has granted approval to Viatris’ Ryzumvi, a 0.75% phentolamine ophthalmic solution, for treating presbyopia in adults. The approval follows clinical studies that investigated its safety and effectiveness. Ryzumvi is already authorized in the U.S. to treat drug‑induced mydriasis, a condition where eye pupils widen after certain medications.

What presbyopia is

Presbyopia is the gradual loss of the eye’s ability to focus on nearby objects, a common effect of ageing that typically appears in people in their early to mid‑40s. It can cause blurred near vision and eye strain, affecting everyday tasks and productivity. Nearly all adults eventually develop some degree of presbyopia, making it a widespread visual impairment if left untreated.

Patients using Ryzumvi are advised to remove contact lenses before applying the drops and to wait 10 minutes before reinserting them. In clinical trials, more than 5% of participants experienced mild eye redness (conjunctival hyperaemia) and irritation at the site of instillation. These reactions were generally self‑resolving and transient, with the most common adverse events reported in 21% and 16% of patients, respectively.

Viatris holds exclusive U.S. rights to market the 0.75% phentolamine solution under a licensing agreement with Opus Genetics. Following the new indication, the company is seeking a national distributor to expand Ryzumvi’s availability across the United States. The expanded clearance could position the drug as a key option for patients seeking non‑surgical presbyopia treatment.

Beyond presbyopia, Viatris remains active in other therapeutic areas and completed a divestiture of its over‑the‑counter business in July 2024. The company’s global operations include headquarters in the U.S. and offices in India, Pittsburgh, and Shanghai, supporting its strategy to deliver eye care products worldwide.