FDA Approves Ryzumvi for Presbyopia, Expanding its Label

The FDA approved phentolamine ophthalmic solution 0.75% (Ryzumvi; Viatris) for the treatment of presbyopia in adults, giving the eye drop a second approved use after its 2023 clearance for pharmacologically induced mydriasis.¹

Expanding Options for an Age-Related Vision Problem

Presbyopia, the gradual, age-related loss of the eye's ability to focus on near objects, ranks among the leading contributors to vision impairment worldwide. Uncorrected presbyopia contributed to visual impairment in roughly 510 million people in 2020, a figure investigators project could approach 866 million by 2050 as the global population ages.² In the US alone, the condition affects an estimated 90% of adults older than 45 years, with symptoms most often surfacing in the early to mid-40s as the eye's lens stiffens and loses the flexibility needed to shift focus between distance and near vision.³

Reading glasses, multifocal contact lenses, and pharmacologic drops such as pilocarpine and aceclidine are already used to manage the condition. Phentolamine works differently: it is a non-selective alpha-1 and alpha-2 adrenergic antagonist that narrows the pupil by blocking receptors on the iris dilator muscle, a sympatholytic mechanism that Opus Genetics, the drug's originator, says avoids engaging the eye's ciliary muscle.

Phentolamine Demonstrates Efficacy in the VEGA Program

The approval rests on findings from 2 pivotal phase 3 trials that Opus Genetics said met their primary and all key secondary efficacy end points, with no treatment-related serious adverse events reported. VEGA-2 (NCT05646719) tested phentolamine both alone and in combination with low-dose pilocarpine across a 2-stage protocol in 333 participants.⁴ VEGA-3 (NCT06542497), a randomized, double-masked, placebo-controlled trial conducted at 39 US sites, enrolled 569 adults aged 45 to 64 years with presbyopia and evaluated once-daily phentolamine monotherapy against placebo, the design that mirrors how Ryzumvi is now labeled for the condition.⁵

In VEGA-3, the primary end point, assessed 12 hours after the eighth daily dose, was the proportion of participants who gained at least 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (roughly 3 lines) in binocular distance-corrected near visual acuity while losing fewer than 5 letters of binocular best-corrected distance visual acuity. Just over 1 in 4 phentolamine-treated participants met that bar (27.2%; n = 92 of 338), compared with 11.5% (n = 26 of 226) on placebo (P < .0001). The effect also appeared quickly: 1 hour after the first dose, 20.6% of phentolamine-treated participants reached the same benchmark, compared with 6.1% on placebo (P = .0002), with no apparent loss of effect through 6 weeks of dosing.

Patient-reported outcomes also favored the drug, with more phentolamine-treated participants reporting satisfaction with their near vision upon waking and improvement in near vision at days 3 and 8 and at week 6 (each P < .0001). The most common ocular adverse reactions across the presbyopia program, each occurring in more than 5% of participants, were conjunctival hyperemia (21%) and instillation site irritation (16%); the majority of reactions were mild, transient, and self-resolving.¹

“This approval marks an important milestone for Opus Genetics, representing our second US drug approval and underscoring our clinical and regulatory capabilities,” George Magrath, MD, chief executive officer of Opus Genetics, said in a news release.³ “It reinforces our commitment to advancing innovative ophthalmic therapies that address unmet patient needs. We are grateful to the patients, investigators, and clinical sites who contributed to this achievement, and we look forward to working closely with our commercial partner to bring Ryzumvi to patients.”

The pivotal data released to date come from company-reported topline results and conference presentations rather than a peer-reviewed publication, and the 2 trials differ in design: VEGA-2 layered phentolamine onto low-dose pilocarpine in a 2-stage protocol, whereas VEGA-3 evaluated the once-daily drop by itself against placebo. For the roughly 9 in 10 US adults older than 45 years living with some degree of presbyopia, the expanded indication gives clinicians another prescription drop to weigh against pilocarpine, aceclidine, and nonpharmacologic corrections such as reading glasses and multifocal contact lenses, alongside Ryzumvi's original role in reversing pharmacologically induced pupil dilation after eye examinations.

References

1. Viatris receives US FDA approval for Ryzumvi (phentolamine ophthalmic solution) 0.75% for the treatment of presbyopia. News release. Viatris Inc. October 16, 2026. Accessed October 19, 2026. https://newsroom.viatris.com/2026-10-16-Viatris-Receives-U-S-FDA-Approval-for-RYZUMVI-R-for-the-Treatment-of-Presbyopia
2. Bourne R, Steinmetz JD, Flaxman S, et al. Trends in prevalence of blindness and distance and near vision impairment over 30 years: an analysis for the Global Burden of Disease Study. Lancet Glob Health. 2021;9(2):e130-e143. doi:10.1016/S2214-109X(20)30425-3
3. Opus Genetics announces FDA approval of phentolamine ophthalmic solution 0.75% for the treatment of presbyopia. News release. Opus Genetics, Inc. October 16, 2026. Accessed October 19, 2026. https://ir.opusgtx.com/press-releases/detail/546/opus-genetics-announces-fda-approval-of-phentolamine-ophthalmic-solution-0-75-for-the-treatment-of-presbyopia
4. Safety and efficacy of Nyxol eye drops as a single agent and with adjunctive low-dose pilocarpine eye drops in subjects with presbyopia (VEGA-2). ClinicalTrials.gov identifier: NCT05646719. Updated July 13, 2026. Accessed October 19, 2026. https://clinicaltrials.gov/study/NCT05646719
5. Evaluate efficacy and safety of POS to improve distance-corrected near visual in participants with presbyopia (VEGA-3). ClinicalTrials.gov identifier: NCT06542497. Updated August 17, 2026. Accessed October 19, 2026. https://clinicaltrials.gov/study/NCT06542497