FDA Expands Ryzumvi Approval to Include Presbyopia

People with aging-associated farsightedness gained a new topical treatment option as the FDA expanded the approval of phentolamine ophthalmic solution 0.75% (Ryzumvi) to include presbyopia, according to Opus Genetics and Viatris.

The eye drops, designed to improve near vision while preserving distance vision, reduce pupillary dilation by means of a sympatholytic mechanism that does not involve the ciliary muscle.

Phentolamine ophthalmic solution initially received FDA approval for mydriasis (abnormal or persistent pupil dilation) induced by adrenergic agonists or parasympatholytic agents in adults and children 3 years or older.

Support for the expanded approval in presbyopia came from the phase III VEGA-2 and VEGA-3 clinical trials. VEGA-2 compared phentolamine eye drops in combination with topical pilocarpine against placebo. VEGA-3, also a placebo-controlled trial, evaluated single-agent phentolamine eye drops. Both trials met the primary endpoint.

Reported this summer, VEGA-3 involved 569 adults ages 40-64 years with binocular photopic distance-corrected near visual acuity (DCNVA) of 20/50 or worse. They were randomized to the 0.75% phentolamine eye drops or placebo, administered nightly. The primary endpoint was the portion of patients who achieved ≥3 lines of DCNVA with <5-letter loss in best-corrected distance visual acuity (BCDVA) on day 8, measured 12 hours after dosing.

The results showed that 27% of patients randomized to the phentolamine eye drops met the primary endpoint as compared with 12% of the placebo group (P<0.0001). The difference in the primary endpoint achieved statistical significance within the first hour after dosing (21% vs 6%, P<0.001).

Adverse events were mostly mild and transient, the most common being conjunctival hyperemia (26%), instillation-site irritation (15%), eye irritation (5.6%), dysgeusia (5.9%), and headache (2.6%).

According to the company statements, phentolamine ophthalmic solution 0.75% is not recommended for use in patients with active ocular inflammation. To avoid potential eye injury or contamination, the vial tip should not come in contact with the eye. Contact lens wearers should remove the lenses prior to application of the eye drops, and then wait 10 minutes before reinserting the lenses.

FDA has approved multiple eye drop products for presbyopia in recent years, including pilocarpine hydrochloride 1.25% (Vuity) in 2021, pilocarpine hydrochloride 0.4% (Qlosi) in 2023, aceclidine 1.44% (Vizz) in 2025, and carbachol/brimonidine tartrate (Yuvezzi) earlier this year.