The US Food and Drug Administration has approved Ryzumvi, an eye drop containing phentolamine 0.75%, for the treatment of presbyopia in adults, Viatris announced on October 16, 2026, one day ahead of the agency’s target decision date. Presbyopia is the gradual loss of the eye’s ability to focus on close objects.
It is why many people in their early to mid 40s start holding a phone or a menu farther away.
The decision adds a new indication to a medicine already sold in the United States. Ryzumvi was first approved in September 2023 to reverse pharmacologically induced mydriasis, the wide pupils left by the dilating drops used during eye examinations. Viatris describes it as the only commercially available, FDA approved product for that use.
Phentolamine works by blocking alpha 1 and alpha 2 adrenergic receptors in the eye, which shrinks the pupil. It does not act on the ciliary muscle, the muscle that changes the lens’s shape, and a smaller pupil gives a greater depth of focus for near work.
The approval rests on two phase 3 trials, VEGA-2 and VEGA-3. Opus Genetics, the developer, says both met their primary goal and all key secondary goals, with no treatment related serious adverse events. VEGA-3 enrolled 545 people at 40 US sites. Near vision was measured 12 hours after the evening dose on day 8: 27.2% of those using the drop had gained at least 15 letters on a reading chart without losing distance sharpness, against 11.5% of those on placebo.
In the presbyopia studies, the most common side effects were eye redness, reported by 21% of patients, and irritation where the drop was applied, reported by 16%. The label advises against use in people with active eye inflammation such as iritis. Contact lens wearers are told to take their lenses out before using the drop and to wait 10 minutes before putting them back in.
Opus Genetics licensed the solution to Viatris, which holds the exclusive rights to sell it in the United States. Viatris is exploring a US partner to market Ryzumvi for presbyopia. The company has not announced a launch date or a price.
