FDA approves Ryzumvi for the treatment of presbyopia

The US Food and Drug Administration has approved Ryzumvi (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia in adults, expanding the product’s label beyond its established use in reversing pharmacologically induced mydriasis.

Announced by Viatris on 16 October 2026, the approval introduces another prescription, non-surgical option for adults experiencing age-related loss of near focusing ability. Presbyopia generally becomes noticeable in the early to mid-40s and can cause blurred near vision, eyestrain and difficulty with tasks such as reading, using a smartphone or working at a computer.

For opticians, the development broadens the conversation around presbyopia management. Spectacles and contact lenses will remain central to correction, but eligible patients may increasingly ask about pharmaceutical alternatives, their likely benefits and how they compare with familiar optical approaches.

A distinct mechanism

Ryzumvi is a preservative-free topical alpha-adrenergic antagonist. It reduces pupil diameter by blocking alpha receptors on the iris dilator muscle, producing a pinhole effect that increases depth of focus. Unlike cholinergic agonists, the sympatholytic mechanism does not directly engage the ciliary muscle.

The recommended regimen for presbyopia is one drop in each eye once daily at night. According to published clinical coverage, the intention is to improve near vision while preserving distance vision, with effects assessed after evening dosing and into the following day.

The expanded indication was supported by the pivotal phase 3 VEGA-2 and VEGA-3 studies. Together, the trials enrolled 902 adults aged 40 to 64 with binocular distance-corrected near visual acuity between 20/50 and 20/100 and binocular best-corrected distance visual acuity of 20/25 or better.

Participants received phentolamine ophthalmic solution 0.75% or placebo in both eyes once daily in the evening. The key efficacy measure was the proportion gaining at least three lines in near visual acuity while losing fewer than five letters of best-corrected distance vision.

In VEGA-2, 22.6% of treated participants met that endpoint on day eight, 12 hours after the seventh dose, compared with 11.0% receiving placebo. In VEGA-3, the corresponding figures were 27.2% and 11.5%. Improvements were also recorded one hour after the first dose in both studies.

Safety and counselling

The most commonly reported ocular adverse reactions in the presbyopia trials were conjunctival hyperaemia, affecting 21% of participants, and instillation-site irritation, affecting 16%. Company information states that most adverse reactions were mild, transient and self-resolving, while the pivotal programme reported no treatment-related serious adverse events.

Ryzumvi is not recommended for patients with active ocular inflammation, such as iritis. The single-dose vial tip should not touch the eye or any other surface, reducing the risk of injury or contamination. Contact lens wearers should remove their lenses before instillation and wait 10 minutes after dosing before reinserting them.

These points will matter when patients seek advice in optical practice. Practitioners should avoid presenting the drop as a universal replacement for reading glasses or multifocal correction. Trial response rates indicate that meaningful improvement was achieved by a subset of treated participants, not everyone, and individual expectations should be realistic.

What the approval means for practice

Ryzumvi was previously approved in the US to reverse pharmacologically induced mydriasis caused by adrenergic agonists, such as phenylephrine, or parasympatholytic agents, such as tropicamide, in adults and children aged three years and older. The new adult presbyopia indication is therefore an expansion of an existing approval rather than the product’s first entry into clinical use.

Patients interested in Ryzumvi should be referred through an appropriate prescribing pathway. Advice must remain within professional competence and local regulations. Once treatment begins, continued optical review can document the patient’s functional experience, reinforce correct contact lens handling and identify symptoms that warrant assessment by the prescriber or another eye-care professional.

The approval does not diminish the advantages of spectacles: they are familiar, adjustable, reversible and capable of correcting additional refractive needs. Nor does it eliminate the role of multifocal or monovision contact lenses. Instead, Ryzumvi adds a different mechanism and dosing approach to a growing category of presbyopia treatments.

For practice teams, informed discussion will be key. Patients should know that the FDA decision applies to adults in the US, that the medicine requires a prescription, and that regulatory status and availability may differ in other countries. Benefits should be balanced against adverse effects, precautions, cost, access and the continued need for regular eye examinations.

As patient awareness grows, opticians are well placed to provide balanced information, identify unsuitable presentations and direct interested adults towards appropriate clinical assessment. The most useful message is not that one option has replaced another, but that presbyopia care is becoming more varied and increasingly tailored to individual priorities.

Reference: Viatris. Viatris Receives U.S. FDA Approval for Ryzumvi for the Treatment of Presbyopia. 16 October 2026.