FDA Approves Tenpoint's Yuvezzi, a Two-Drug Eye Drop for Presbyopia

The US Food and Drug Administration has approved Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1%, a once-daily eye drop for presbyopia in adults, Tenpoint Therapeutics said on January 28, according to the company's announcement, read via the website of its investor Sofinnova Partners. Tenpoint described it as the first and only dual-agent eye drop for presbyopia.

Presbyopia is the gradual loss of near vision that typically begins around age 45. Tenpoint, which is based in London and Seattle, said the condition affects about 128 million people in the US. The product was previously known as Brimochol PF, and the company expects it to be broadly available in the US in the second quarter of 2026.

Two Phase 3 trials

The approval is based on two Phase 3 studies, which Tenpoint said enrolled more than 800 patients in total. In BRIO I, the combination showed a superior benefit over each of its two active ingredients used alone, which the company noted is a requirement for FDA approval of a fixed-dose combination.

In BRIO II, a vehicle-controlled study, Yuvezzi met all primary near-vision endpoints, with statistically significant improvement of three lines or more in binocular uncorrected near visual acuity over eight hours, without the loss of one line or more in distance visual acuity, Tenpoint said. The company said no treatment-related serious adverse events were seen in more than 72,000 treatment days monitored in BRIO II, a 12-month study.

The trial results were reported by the company; Tenpoint cited data on file for the BRIO findings. In BRIO II, reported adverse events of eye redness occurred in 2.8% of subjects receiving Yuvezzi, compared with 10.7% of those receiving carbachol alone, according to the release. The most common side effects listed are headache, impaired vision and temporary eye pain or irritation.

How the drop works

Tenpoint said the proposed mechanism is pupil constriction, which creates a pinhole effect that improves near visual acuity and depth of focus. Carbachol constricts the iris sphincter and ciliary body, while brimonidine tartrate blocks contraction of the iris dilator muscle, which the company said increases carbachol's selectivity for the pupil. The effect starts about 30 minutes after one drop and lasts up to 10 hours, according to the company.

"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," said Henric Bjarke, Tenpoint's chief executive, in the release.

As reported by Healio, Yuvezzi is the fourth topical treatment approved for presbyopia, following AbbVie's Vuity, Orasis Pharmaceuticals' Qlosi and Lenz Therapeutics' Vizz.