Viatris Inc. announced that the U.S. Food and Drug Administration (FDA) approved RYZUMVI® (phentolamine ophthalmic solution 0.75%) to treat presbyopia in adults. The common, age-related condition causes a gradual loss of near-focusing ability.
The approval expands RYZUMVI’s approved uses. The drug is already available in the U.S. to reverse pharmacologically induced pupil dilation.
The new indication was supported by positive results from two pivotal Phase 3 clinical trials. Viatris holds commercialization rights through an agreement with Opus Genetics and said it is exploring a potential U.S. launch partnership for the presbyopia indication.