Tenpoint Therapeutics Ltd. Announces FDA Approval of YUVEZZI™, the First and Only Combination Eye Drop Approved to Treat Presbyopia

发布时间： 2026-02-05 阅读：3次

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On February 01, 2026--Tenpoint Therapeutics announced that the U.S. Food and Drug Administration (FDA) approved YUVEZZI™ (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1%, previously known as BRIMOCHOL™ PF, the first and only dual-agent eye drop for the treatment of presbyopia in adults. YUVEZZI achieves miosis from 30-minutes up to 10 hours with one drop daily

The FDA approval of YUVEZZI is based on positive data from two Phase 3 studies. The Phase 3 BRIO I study demonstrated a superior benefit of the combination therapy over the individual actives – a requirement for FDA approval of a fixed-dose combination. In the second Phase 3 study, BRIO II, which was vehicle-controlled, YUVEZZI achieved all primary near vision improvement endpoints with statistically significant three-lines or greater improvement in binocular uncorrected near visual acuity (BUNVA) over 8 hours, without the loss of one line or more in binocular uncorrected distance visual acuity (BUDVA).

In addition, YUVEZZI was well-tolerated with no treatment-related serious adverse events observed in the more than 72,000 treatment days monitored in BRIO II, the longest safety study (12 months) conducted in presbyopia to-date. The most common side effects of YUVEZZI are headache, impaired vision and temporary eye pain or eye irritation.

Eye redness was not a commonly reported side effect in clinical trials of YUVEZZI. In BRIO I and BRIO II the reports of adverse events of ocular hyperemia (eye redness) were low. In BRIO II, the rate of reported adverse events of ocular hyperemia (eye redness) was lower in subjects receiving YUVEZZI (2.8%) than carbochol alone (10.7%).