Tenpoint Therapeutics announced the FDA approval of Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1% for the treatment of presbyopia in adults. The company says Yuvezzi is the first and only FDA-approved dual-agent eyedrop for presbyopia. Tenpoint expects it to become broadly commercially available in the United States in the second quarter of 2026.
Trial Data Supporting Approval
FDA approval was based on results from two Phase 3 clinical trials, BRIO I and BRIO II, which enrolled more than 800 patients. BRIO I demonstrated a superior benefit of the fixed-dose combination compared with the individual active ingredients, meeting FDA requirements for combination therapies.
In the vehicle-controlled BRIO II study, Yuvezzi met all primary near vision endpoints, achieving statistically significant three-lines or greater improvements in binocular uncorrected near visual acuity over 8 hours, without a loss of one line or more in binocular uncorrected distance visual acuity. The company reported that Yuvezzi achieved miosis beginning at 30 minutes and lasting up to 10 hours with once-daily dosing.
Safety and Tolerability
Tenpoint says Yuvezzi was well tolerated, with no treatment-related serious adverse events observed across more than 72,000 treatment days in BRIO II, which the company says is the longest safety study conducted in presbyopia to date. The most common side effects reported were headache, impaired vision, and temporary eye pain or irritation.
Eye redness was not commonly reported in the clinical trials. In BRIO II, ocular hyperemia occurred in 2.8% of subjects receiving Yuvezzi compared to 10.7% of subjects receiving carbachol alone.
Company Perspective
Presbyopia affects approximately 2 billion people globally and an estimated 128 million people in the United States, according to the company.
“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,” said Henric Bjarke, Tenpoint Therapeutics CEO. “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.”