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.