Viatris has received approval from the U.S. Food and Drug Administration (FDA) for RYZUMVI (phentolamine ophthalmic solution 0.75%) to treat presbyopia in adults. The approval expands the use of the eye drop, which was previously approved in the United States to treat pharmacologically induced mydriasis, a condition involving pupil dilation caused by certain medicines.
Announced on October 16, 2026, the FDA decision gives RYZUMVI a new indication for presbyopia, an age-related condition that makes it harder for people to focus on nearby objects. The condition commonly becomes noticeable in the early to mid-40s and can cause blurred near vision and eye strain, affecting everyday activities such as reading and using digital devices.
RYZUMVI contains phentolamine, a medicine that acts on alpha-adrenergic receptors. The eye drop works by reducing pupil size, helping improve near vision without directly changing the eye’s ability to focus through the lens.
The approval was supported by results from the Phase 3 VEGA-2 and VEGA-3 clinical trials, which evaluated RYZUMVI in adults with presbyopia. Both studies met their primary endpoints and all key secondary endpoints, according to the company.
RYZUMVI was already approved in the United States for treating pharmacologically induced mydriasis in adults and children aged three years and older. With the latest decision, its approved uses now include the treatment of presbyopia in adults.
Viatris is exploring the possibility of partnering with another company to commercialize RYZUMVI for presbyopia in the United States. The product was developed under a global licensing agreement between Opus Genetics and Viatris, which grants Viatris exclusive U.S. commercialization rights.
Presbyopia is a common age-related vision condition that develops as the eye gradually loses its ability to focus on nearby objects. Although reading glasses and other corrective options are widely used, pharmaceutical treatments offer another approach to managing the condition.
RYZUMVI may cause side effects, including conjunctival hyperemia, or eye redness, and irritation at the site where the drops are applied. The company advises that the treatment is not recommended for people with active eye inflammation, such as iritis. Contact lens users should remove their lenses before applying the drops and wait 10 minutes before putting them back in.
The FDA approval marks a new step in Viatris’ ophthalmology portfolio and expands the potential use of RYZUMVI beyond its existing indication. The company’s next priority will be determining the right U.S. commercialization strategy for its newly approved presbyopia treatment.