FDA approves Viatris and Opus Genetics' Ryzumvi eye drop for presbyopia

The U.S. Food and Drug Administration on Oct. 16 approved Ryzumvi, a phentolamine ophthalmic solution 0.75%, for the treatment of presbyopia in adults, giving the age-related loss of near focus a fourth prescription eye drop option and the first that does not rely on the cholinergic pathway used by earlier drops. The drug was developed by Opus Genetics of Research Triangle Park, North Carolina, and is licensed in the United States to Pittsburgh-based Viatris, which said it is now exploring a U.S. partner to commercialize the product for the new indication.

How the drug works

Presbyopia is the gradual loss of the eye's ability to focus on nearby objects, typically noticeable in a person's early to mid-40s, as Viatris described it in its release. It affects nearly everyone with age, and reading glasses, bifocals and multifocal contact lenses remain the standard corrections. Prescription drops aim to give patients a period of improved near vision without lenses.

The drops approved before Ryzumvi work through the cholinergic system. AbbVie's Vuity and Orasis Pharmaceuticals' Qlosi use pilocarpine, and LENZ Therapeutics' Vizz, approved in July 2025, uses aceclidine. These agents constrict the pupil to create a pinhole effect that extends depth of focus. Pilocarpine also acts on the ciliary muscle, which is linked to side effects such as brow ache and shifts in distance vision.

Phentolamine takes a different route. It is an alpha-adrenergic antagonist that relaxes the iris dilator muscle, reducing pupil size without stimulating the focusing muscle. Ryzumvi was first approved in 2023 to reverse pharmacologically induced mydriasis, the pupil dilation produced during eye exams, in adults and children 3 years and older. Viatris says it is the only commercially available FDA-approved product for that use. Opus, formerly known as Ocuphire Pharma, called the presbyopia decision its second U.S. drug approval.

Industry implications

The approval widens a category that has moved from one product to four in five years. Each new entrant has tried to differentiate on mechanism, onset, duration or tolerability, and Ryzumvi's non-cholinergic profile gives prescribers an option for patients who did not tolerate or respond to miotic drops. Its label carries few precautions: it is not recommended for patients with active ocular inflammation such as iritis, and contact lens wearers should remove lenses before dosing and wait 10 minutes before reinserting them.

The clinical result also sets expectations. A 27.2% responder rate on the strict 15-letter endpoint, against 11.5% on placebo, shows a clear drug effect, yet most treated patients did not reach that threshold. That pattern is common across the category and points to positioning as a convenience option for early presbyopes rather than a replacement for corrective lenses.

For eye care practices, the commercial question is whether patients will pay for an ongoing prescription drop. Uptake of earlier products has depended on consumer awareness, insurance coverage and the time clinicians spend counseling patients, all of which require sustained investment from the marketer.

Competitive and supply chain implications

The most notable commercial detail is that Viatris, which holds exclusive U.S. rights under a global licensing agreement with Opus, said it is exploring a U.S. partner to commercialize Ryzumvi for presbyopia. That suggests the company may prefer to share the cost of a consumer-facing launch rather than build it alone, and it opens a door for a specialty ophthalmology company or a consumer eye care player to add a differentiated asset.

The rival products are each backed by a different kind of company. AbbVie brings a large eye care sales force to Vuity, while LENZ is a focused developer building its own launch for Vizz. A partner for Ryzumvi would enter a field where awareness campaigns, payer access and sampling programs have already shaped prescriber habits.

On the supply side, Ryzumvi is already a marketed product for mydriasis, so manufacturing and distribution are established. Neither company disclosed changes to production capacity or suppliers tied to the new indication.

Regional implications

The decision applies to the United States only. Viatris holds the U.S. commercialization rights, and neither release described regulatory filings for presbyopia in Europe, Japan or other markets. Any expansion outside the United States would depend on the terms of the global license and on separate regulatory submissions.

For North Carolina's Research Triangle, the approval adds a second U.S. approval to a local ophthalmology developer's record and brings milestone revenue that Opus can direct toward its retinal gene therapy pipeline. For Viatris, a global generics and branded drug company, the decision adds a second approved indication to an eye care product it already sells in the United States.

What comes next

• Viatris' selection of a U.S. commercialization partner for the presbyopia indication, and the deal terms.
• Announcement of launch timing, pricing and packaging for presbyopia, none of which were disclosed with the approval.
• Disclosure of the milestone amount, likely in Opus' next quarterly report.
• Progress in the LYNX Phase 3 program evaluating phentolamine 0.75% for dim-light vision disturbances after keratorefractive surgery.
• Opus' continued development of its gene therapy programs, led by OPGx-LCA5 and OPGx-BEST1.

Sources

• Opus Genetics: FDA approval of phentolamine ophthalmic solution 0.75% for presbyopia (Oct. 16, 2026)
• Viatris: U.S. FDA approval for Ryzumvi for the treatment of presbyopia (Oct. 16, 2026)
• Opus Genetics SEC filing with VEGA-3 topline results (Aug. 13, 2025)
• LENZ Therapeutics SEC filing on FDA approval of Vizz (July 31, 2025)

Image: Reading glasses, by James Sutton via Wikimedia Commons, CC0. Cropped and edited by Credence Research.