FDA approves Ryzumvi eye drops for presbyopia

On October 19, 2026, the FDA approved Ryzumvi (phentolamine ophthalmic solution 0.75%) for adult presbyopia, expanding its 2023 approval for mydriasis. Marketed by Viatris under license from Opus Genetics, the sympatholytic drop improves near vision without engaging the ciliary muscle. Approval follows the Phase III VEGA-3 trial, where 27% of treated adults achieved significant vision gains versus 12% on placebo. Main side effects include mild conjunctival hyperemia.

Ryzumvi approval and commercialization

• ▪The FDA approved Ryzumvi (phentolamine ophthalmic solution 0.75%) to treat presbyopia in adults on October 19, 2026
• ▪Viatris markets Ryzumvi and holds exclusive U.S. commercialization rights through a licensing agreement with Opus Genetics
• ▪Ryzumvi was previously approved by the FDA in 2023 to treat pharmacologically induced mydriasis in adults and children ages 3 years or older

Phase III clinical trial results

• ▪The most common adverse events of Ryzumvi in presbyopia trials were mild and transient, including conjunctival hyperemia in 26% of patients and instillation-site irritation in 15%
• ▪Support for Ryzumvi's expanded FDA approval in presbyopia came from the Phase III VEGA-2 and VEGA-3 clinical trials
• ▪In the VEGA-3 trial (569 adults ages 40–64), 0.75% phentolamine eye drops achieved significant primary endpoint response vs placebo within the first hour (21% vs 6%) and day 8 (27% vs 12% gaining at least 3 near visual acuity lines)
• ▪The Phase III VEGA-2 clinical trial evaluated phentolamine eye drops in combination with topical pilocarpine against placebo

Usage instructions and precautions

• ▪Patients who wear contact lenses must remove them before applying Ryzumvi eye drops and wait at least 10 minutes before reinserting the lenses
• ▪Ryzumvi is not recommended for patients with active ocular inflammation, such as iritis
• ▪To reduce the risk of eye injury or contamination, patients applying Ryzumvi must avoid touching the vial tip to the eye or any surface

Presbyopia treatment options

• ▪Presbyopia is commonly managed with optical correction like reading glasses, bifocals, multifocals, contact lenses, and miotic eye drops that increase depth of focus via pupillary constriction
• ▪Prior to Ryzumvi's October 19, 2026 expansion to presbyopia, the FDA approved multiple presbyopia eye drops, including Vuity in 2021, Qlosi in 2023, Vizz in 2025, and Yuvezzi in 2026