FDA Approves Combination Yuvezzi Eye Drop for Presbyopia in Adults

THURSDAY, Feb. 5, 2026 (HealthDay News) -- The U.S. Food and Drug Administration has approved Yuvezzi (carbachol and brimonidine tartrate) ophthalmic solution 2.75 percent/0.1 percent, previously known as Brimochol PF, as the first and only dual-agent eye drop for the treatment of presbyopia in adults.The approval is based on positive data from two phase 3 studies of more than 800 patients. As a fixed-dose, combination treatment, Yuvezzi showed a superior benefit to the individual actives in the phase 3 BRIO I study. In the second phase 3 study, BRIO II, Yuvezzi achieved all primary near-vision improvement end points for three lines or greater improvement in binocular uncorrected near visual acuity over eight hours when compared with a vehicle comparator, without the loss of one line or more in binocular uncorrected distance visual acuity.YuvezzI was well tolerated, with no treatment-related serious adverse events seen as part of a 12-month safety study in BRIO II. The most common side effects were headache, impaired vision, and temporary eye pain or eye irritation. "The FDA approval of Yuvezzi represents a significant milestone for the millions of people in the U.S. living with presbyopia and its daily frustrations and challenges," Henric Bjarke, CEO of Tenpoint Therapeutics, said in a statement. "As the first FDA-approved dual-agent eye drop for presbyopia, Yuvezzi leverages the mechanisms of carbachol and brimonidine tartrate to deliver sharp near vision with favorable tolerability."Approval of Yuvezzi was granted to Tenpoint Therapeutics.More Information.Sign up for our weekly HealthDay newsletter

FDA Approves Combination Yuvezzi Eye Drop for Presbyopia in Adults

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