FDA Expands Ryzumvi Approval To Include Presbyopia

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The FDA expanded approval of phentolamine ophthalmic solution 0.75% (Ryzumvi) to include presbyopia, according to Opus Genetics and Viatris. In the VEGA-3 trial, 27% of treated participants met the near-vision primary endpoint, compared with 12% receiving placebo; the companies also said a second phase III trial supported the decision.

The FDA has expanded approval of phentolamine ophthalmic solution 0.75%, sold as Ryzumvi, to include treatment of presbyopia, an age-associated difficulty focusing on nearby objects. Opus Genetics and Viatris announced the decision, adding a new use for the eye drops, which were previously approved for certain cases of abnormal or persistent pupil dilation.

The expanded indication was supported by two phase III studies, VEGA-2 and VEGA-3, both of which the companies said met their primary endpoints. VEGA-2 compared phentolamine drops used with topical pilocarpine against placebo. VEGA-3 tested phentolamine alone against placebo. The supplied report does not provide detailed results from VEGA-2.

VEGA-3 enrolled 569 adults ages 40 to 64 with binocular photopic distance-corrected near visual acuity of 20/50 or worse. Participants received nightly phentolamine 0.75% or placebo. The primary endpoint measured whether patients gained at least three lines in near visual acuity while losing fewer than five letters in best-corrected distance vision on day eight, 12 hours after dosing.

Twenty-seven percent of the phentolamine group met that endpoint, compared with 12% of the placebo group (P<0.0001), according to the trial results reported this summer. The difference was statistically significant within the first hour after dosing as well: 21% versus 6% (P<0.001). These figures describe the trial’s specified outcomes; they do not establish how every patient will respond in routine use.

A New Option for Near Vision

The decision gives adults with presbyopia another prescription eye-drop option in a market that has added several products in recent years. The reported VEGA-3 result suggests that some participants improved near-vision test scores while meeting the trial’s limit on loss of distance vision. The placebo comparison offers a measure of the treatment’s performance under study conditions, but the reported results do not show that all users will experience the same benefit.

Ryzumvi’s expanded use also gives clinicians and patients another product to discuss alongside other approved drops. The supplied material does not compare Ryzumvi directly with those medicines, so the results cannot establish which option is more effective or appropriate for a particular person. Treatment choice may depend on individual circumstances and the product’s prescribing information.

Ryzumvi’s Earlier FDA Use

Before this decision, phentolamine ophthalmic solution 0.75% was approved to treat mydriasis induced by adrenergic agonists or parasympatholytic agents in adults and children age three and older. The newly announced indication concerns presbyopia, a separate condition involving difficulty with near focus. The report describes phentolamine’s action as reducing pupil dilation through a sympatholytic mechanism that does not involve the ciliary muscle.

The FDA has approved other prescription drops for presbyopia in recent years, according to the source report: pilocarpine hydrochloride 1.25% (Vuity) in 2021, pilocarpine hydrochloride 0.4% (Qlosi) in 2023, aceclidine 1.44% (Vizz) in 2025, and carbachol/brimonidine tartrate (Yuvezzi) earlier in 2026. Ryzumvi’s expanded approval adds phentolamine to that group.

“The companies announced that the FDA expanded Ryzumvi’s approval to include presbyopia.”

— Opus Genetics and Viatris

Safety and Use Questions

The supplied report does not include the FDA’s full prescribing information, the complete VEGA-2 results, or additional details about the approved dosing instructions for the presbyopia indication. It also does not provide evidence comparing Ryzumvi directly with other approved drops or information on longer-term outcomes. The reported VEGA-3 endpoint was measured on day eight, so these results alone do not answer how benefits may vary over extended use.

In VEGA-3, reported adverse events were mostly mild and transient. The most common were conjunctival hyperemia (26%), instillation-site irritation (15%), eye irritation (5.6%), dysgeusia (5.9%), and headache (2.6%). The companies said the drops are not recommended for people with active ocular inflammation. They also advised avoiding contact between the vial tip and the eye and removing contact lenses before application, then waiting 10 minutes before reinserting them. Patients should consult an eye-care professional about product-specific risks and use.

Prescribing Details and Availability

The next practical step for patients and clinicians is to review the updated FDA-approved labeling for the presbyopia indication, including dosing, warnings, and use instructions. The source report does not specify when the product will be available for this use, whether commercial packaging or pricing will change, or what additional post-approval data may be collected.

Further information from the companies or regulators could clarify those points. For now, the confirmed development is the expanded FDA indication, supported by two phase III studies, with the detailed outcome figures provided here coming from VEGA-3.

Key Questions

What did the FDA approve for Ryzumvi?

The FDA expanded approval of phentolamine ophthalmic solution 0.75% (Ryzumvi) to include presbyopia. It was previously approved for certain forms of medication-induced pupil dilation.

What did the VEGA-3 trial find?

In VEGA-3, 27% of participants using phentolamine met the primary near-vision endpoint, compared with 12% using placebo. The endpoint required at least a three-line near-vision gain with fewer than five letters lost in best-corrected distance vision, measured on day eight 12 hours after dosing.

What side effects were reported?

The most common reported events included conjunctival hyperemia, instillation-site irritation, eye irritation, dysgeusia, and headache. The report says adverse events were mostly mild and transient; patients should consult an eye-care professional for individual guidance.

Can Ryzumvi be compared with other presbyopia drops?

The supplied results do not include a head-to-head comparison with other approved products. They show Ryzumvi’s results against placebo in VEGA-3, not how it performs relative to other treatments.

Source: rss