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

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On Oct. 16, 2026, Viatris announced that the U.S. Food and Drug Administration (FDA) has approved RYZUMVI® (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia in adults. RYZUMVI is currently approved in the United States for the treatment of pharmacologically-induced mydriasis and is the only commercially available FDA-approved product for that use. This approval expands the product’s indications to include presbyopia.

Viatris is exploring the potential for a partner in the United States to commercialize RYZUMVI for the treatment of presbyopia. Opus Genetics and Viatris (through an affiliated entity) are parties to a global licensing agreement which provides for the development of phentolamine ophthalmic solution 0.75% and grants exclusive rights to Viatris to commercialize the product in the United States.

Presbyopia is the gradual loss of near focusing ability due to aging, that typically becomes noticeable in the early to mid-40s. It is a nearly universal condition that, when uncorrected, contributes significantly to vision-related disability. Presbyopia leads to symptoms like eye strain and blurred near vision, impacting daily tasks and productivity.

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Source: PR Newswire
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