FDA Approves Ryzumvi Eye Drops for Presbyopia. In the Pivotal Trial, About 1 in 4 Patients Reached the Near-Vision Goal.
The Oct. 16 approval adds adults with presbyopia to the label of phentolamine ophthalmic solution 0.75%. In the VEGA-3 trial, 27.2% of treated patients reached the primary near-vision endpoint, against 11.5% on placebo.
On Oct. 16, Viatris announced that the Food and Drug Administration (FDA) approved Ryzumvi (phentolamine ophthalmic solution 0.75%) for presbyopia in adults. In the Viatris release, the company said the approval expands the label of a drop already approved for reversing pharmacologically induced mydriasis.
Presbyopia, the age-related loss of near focus, typically becomes noticeable in the early to mid-40s. Ryzumvi adds a prescription drop to the options for patients who would otherwise reach for readers.
How it works
Phentolamine is a nonselective alpha-1 and alpha-2 adrenergic antagonist. According to developer Opus Genetics, it blocks alpha-1 receptors on the iris dilator muscle to make the pupil smaller. Because it does not act on the ciliary muscle as the parasympathomimetic drops do, the company says it is designed to avoid risks such as retinal tears or detachment linked to that class. Opus has said the effect on pupil size lasts up to 20 hours, in the February release announcing that the FDA had accepted the application.
The trial evidence
The application rested on two phase 3 trials, VEGA-2 and VEGA-3, which Opus says both met their primary and key secondary endpoints. In VEGA-3, the primary endpoint was a gain of at least 15 letters in binocular distance-corrected near visual acuity without losing 5 or more letters of distance acuity, measured 12 hours after dosing on day 8. Opus reported that 27.2 percent of treated participants met it, compared with 11.5 percent on placebo (P<0.0001). The trial registry lists 569 enrolled participants, and the protocol called for one drop in each eye once daily in the evening near bedtime.
Those are company-reported topline results; VEGA-2 figures were not given in the sources we reviewed. The updated prescribing information was not yet posted on DailyMed or Drugs@FDA on Oct. 17, so the approved presbyopia dosing should be confirmed against the label once it appears.
Roughly one in four treated patients reached the primary endpoint, against about one in nine on placebo. That is a real effect, and a reason to set expectations before the first prescription.
Safety
In the presbyopia trials, the most common ocular adverse reactions, reported in more than 5 percent of subjects, were conjunctival hyperemia (21 percent) and instillation site irritation (16 percent), per Viatris, which describes most reactions as mild, transient and self-resolving. The drop is not recommended in patients with active ocular inflammation such as iritis. Contact lens wearers should remove lenses before instillation and wait 10 minutes before reinserting them. Redness in about one in five users is worth mentioning up front; our report on Brytly covers a separate nonprescription drop for eye redness.
Availability
Viatris holds exclusive U.S. commercialization rights under a global licensing agreement with Opus Genetics and says it is exploring a U.S. partner to commercialize Ryzumvi for presbyopia. No partner, price or launch date has been announced.
What it means in clinic
Nothing changes for patients today, because the drop is not yet marketed for presbyopia. When it is, expect questions. A short, accurate answer covers the size of the trial effect, nightly dosing in the trial, redness as the most common side effect, and the contact lens and inflammation precautions. Ask the ophthalmologists and optometrists you refer to which presbyopia drops they plan to use and how they will screen for active inflammation, so your advice matches theirs.
Reported, fact-checked and edited by The Script Pad's editorial staff.
This article is for professional education and does not replace clinical judgment. Treatment decisions should be based on the individual patient and current guidelines.
