The US Food and Drug Administration has approved Ryzumvi (phentolamine ophthalmic solution 0.75 percent) for the treatment of presbyopia in adults, Viatris announced on October 16. The decision came one day ahead of the October 17 target action date and gives the preservative free drop a second indication: it has been sold since 2024 to reverse pharmacologically induced pupil dilation after eye exams, and remains the only commercially available FDA approved product for that use.
The approval rests on the Phase 3 VEGA-2 and VEGA-3 trials, which met their primary and all key secondary endpoints with no treatment related serious adverse events reported. In VEGA-3, 27.2 percent of treated participants gained at least 15 letters of near visual acuity, three lines on an eye chart, without losing five or more letters of distance acuity, against 11.5 percent on placebo, measured 12 hours after dosing on day eight.
Phentolamine is a non selective alpha 1 and alpha 2 adrenergic antagonist. It shrinks the pupil by blocking the iris dilator muscle rather than engaging the ciliary muscle, a pinhole mechanism designed to sharpen near focus while preserving distance vision. That distinguishes it from pilocarpine based rivals, whose ciliary action is linked to headache and brow ache complaints.
The commercial structure is split. Opus Genetics developed the drug and called the decision its second US approval; Viatris, through an affiliated entity, holds exclusive US commercialization rights under a global licensing agreement, and the approval triggers milestone economics for Opus under that deal. Notably, Viatris said it is exploring a partner to commercialize Ryzumvi for presbyopia in the United States, so the launch path is not yet settled.
Presbyopia, the age related loss of near focusing ability that typically appears in the early to mid 40s, affects roughly 90 percent of US adults over 45. A daily drop will not replace reading glasses for most people, but the category has already shown consumer demand, and a second mechanism with a full day duration claim widens the choice for the large minority who dislike spectacles.