The FDA has expanded approval of Ryzumvi (phentolamine ophthalmic solution 0.75%) to include presbyopia, adding a new topical option for age-related near vision loss. The eye drops, developed by Opus Genetics and Viatris, work by reducing pupillary dilation through a sympatholytic mechanism that does not involve the ciliary muscle. The product was previously approved for mydriasis induced by adrenergic agonists or parasympatholytic agents in adults and children 3 years and older.
The expanded approval is supported by the phase III VEGA-2 and VEGA-3 trials. In VEGA-3, 569 adults aged 40–64 with binocular photopic distance-corrected near visual acuity of 20/50 or worse were randomized to nightly phentolamine or placebo. On day 8, 27% of the phentolamine group met the primary endpoint of at least 3 lines of improvement in near vision with less than 5 letters of distance vision loss, compared with 12% of the placebo group (P<0.0001). The difference reached statistical significance within the first hour after dosing (21% vs 6%, P<0.001).
Adverse events were mostly mild and transient, with conjunctival hyperemia (26%), instillation-site irritation (15%), dysgeusia (5.9%), eye irritation (5.6%), and headache (2.6%) reported. The companies advise against use in patients with active ocular inflammation, and contact lens wearers should wait 10 minutes after instillation before reinserting lenses. Ryzumvi joins a growing field of FDA-approved presbyopia eye drops, including pilocarpine-based products and aceclidine, though the source notes no direct comparisons among them.