Tenpoint Therapeutics, Ltd announced in a press release that the US Food and Drug Administration (FDA) approved Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1%, previously known as Brimochol PF, the first dual-agent eye drop for the treatment of presbyopia in adults. Yuvezzi said the eye drop is expected to be broadly commercially available in the US in the second quarter of 2026.

According to Tenpoint Therapeutics, the FDA approval of Yuvezzi is based on positive data from 2 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, the company said in the press release.

In the second phase 3 study, BRIO II, which was vehicle-controlled, Yuvezzi achieved all primary near vision improvement endpoints with statistically significant 3-lines or greater improvement in binocular uncorrected near visual acuity (BUNVA) over 8 hours, without the loss of 1 line or more in binocular uncorrected distance visual acuity (BUDVA). 

In addition, the company said 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 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%), the company said.

“The FDA approval of Yuvezzi represents a significant milestone for the millions of people in the US living with presbyopia and its daily frustrations and challenges,” said Henric Bjarke, chief executive officer of Tenpoint Therapeutics, in the press release. “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. People deserve treatments that not only work but also can fit conveniently into their daily lives, and Yuvezzi brings an innovative new option to the presbyopia category. This approval marks the first groundbreaking therapy for Tenpoint Therapeutics aimed at advancing our mission to bring innovation to the aging eye.”