Pittsburgh – October 16, 2026 -- The U.S. Food and Drug Administration (FDA) has approved Viatris Inc.'s RYZUMVI (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia in adults, adding a second indication to a product already on the U.S. market.
RYZUMVI is currently approved in the United States for pharmacologically-induced mydriasis and is the only commercially available FDA-approved product for that use. The presbyopia approval expands its label beyond that use.
Viatris Is Exploring a U.S. Commercialization Partner for the Presbyopia Indication
Viatris said it is exploring the potential for a partner in the United States to commercialize RYZUMVI for presbyopia. The company disclosed no partner, timeline or financial terms.
Viatris holds exclusive U.S. commercialization rights through a global licensing agreement with Opus Genetics. The agreement, signed through a Viatris affiliate, covers the development of phentolamine ophthalmic solution 0.75%.
Label Lists Conjunctival Hyperemia in 21% of Presbyopia Subjects
In presbyopia studies, the most common ocular adverse reactions, reported in more than 5% of subjects, were conjunctival hyperemia (21%) and instillation site irritation (16%).
In the mydriasis indication, instillation site discomfort, including pain, stinging and burning, was reported in 16% of subjects. Conjunctival hyperemia was reported in 12%. Dysgeusia (6%) was the only non-ocular adverse reaction above the 5% threshold. Most reactions were mild, transient and self-resolving.
Label Restricts Use in Active Ocular Inflammation and Requires Contact Lens Removal
RYZUMVI is not recommended for patients with active ocular inflammation, such as iritis. Contact lens wearers must remove their lenses before instillation and wait 10 minutes after dosing before reinserting them. Users must also avoid touching the vial tip to the eye or any other surface to prevent injury or contamination.
The mydriasis indication covers adults and pediatric patients aged 3 years and older. The presbyopia indication covers adults only.
Presbyopia Typically Becomes Noticeable in the Early to Mid-40s
Presbyopia is the gradual age-related loss of near focusing ability. The company describes it as nearly universal and says it contributes significantly to vision-related disability when uncorrected. Symptoms include eye strain and blurred near vision.