FDA Accepts Viatris Presbyopia Treatment Application, Approves Rival Eye Drop Therapy
The FDA accepted Viatris' application for phentolamine ophthalmic solution 0.75% to treat presbyopia, with a decision expected October 2026. Separately, the agency approved Yuvezzi, a once-daily combination eye drop for age-related near vision loss.
The U.S. Food and Drug Administration has accepted Viatris Inc.'s supplemental New Drug Application for phentolamine ophthalmic solution 0.75% for the treatment of presbyopia, with a PDUFA goal date of October 17, 2026. Presbyopia is an age-related decline in the eye's ability to focus on nearby objects.
The submission is supported by data from the pivotal Phase 3 VEGA-2 and VEGA-3 trials, which met primary and all key secondary endpoints with no treatment-related serious adverse events reported. Phentolamine ophthalmic solution 0.75% is currently approved in the U.S. for treating pharmacologically-induced mydriasis and is marketed as Ryzumvi.
Separately, the FDA approved Yuvezzi as the only FDA-approved combination eye drop for treating presbyopia. Yuvezzi's ingredients—carbachol and brimonidine tartrate—work with the natural vision system to allow patients to see up close more easily.
Carbachol constricts the pupil to increase depth of focus, creating a "pinhole effect" that makes close objects appear sharper without additional correction. Brimonidine tartrate blocks dilation, helping keep pupils constricted for a longer period of time, further improving visual clarity.
An initial study found that combining carbachol and brimonidine was more effective than treatment with just one of the respective ingredients alone. A follow-up study conducted over 12 months found significant improvement in near vision. Patients who were treated with Yuvezzi read at least three more lines on an eye chart, without experiencing limits to their distance sight, than those using a placebo or drops with just one of the ingredients.
A single drop in each eye was effective in assisting with vision correction for eight hours at a time without a need for glasses or contacts, meaning a once-daily dose can help correct vision for nearly an entire workday. The main side effects of the drops included eye pain, blurry vision, eye irritation, and headache.
Approximately 128 million Americans suffer from presbyopia. The condition is extremely common, with most people noticing vision changes in their 40s. By age 50 or 60, nearly everyone will need correction to see up close. Current treatments on the market include reading glasses, progressive glasses, multifocal contact lenses, and, in some cases, surgical interventions, like lens implants.
Viatris shares were up more than 1% in pre-market trading after closing at $16.07 on Tuesday.