Yuvezzi FDA-Approved as the First Dual-Agent Eye Drop for Presbyopia

The FDA has approved Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1% for the treatment of presbyopia in adults, making it the first and only dual-agent eye drop approved for this age-related vision condition, according to Tenpoint Therapeutics.

Presbyopia is a gradual, age-related loss of near vision that occurs when the eye’s natural lens becomes less flexible and can no longer change shape easily to focus on close objects. This can make everyday tasks such as reading, using a smartphone or working at a computer more difficult.

While glasses, contact lenses and surgical approaches are commonly used, they may not be suitable or convenient for all patients.

Yuvezzi is a fixed-dose combination eye drop administered once daily. It combines carbachol, a cholinergic agent, with brimonidine tartrate, an alpha-adrenergic agonist. Together, the two agents are designed to constrict the pupil and create a “pinhole effect,” which increases depth of focus and improves the clarity of near objects.

Carbachol stimulates the iris sphincter muscle, causing the pupil to become smaller. Brimonidine inhibits the iris dilator muscle and relaxes tonic contraction of the ciliary muscle, which enhances pupil selectivity and supports sustained pupil constriction. The combined action is intended to improve near visual acuity while maintaining tolerability over several hours.

Yuvezzi is the first FDA-approved dual-agent eye drop for presbyopia, following last year’s approval of Vizz by LENZ Therapeutics, the first aceclidine-based therapy cleared for the same indication.

Yuvezzi’s FDA approval was based on results from two pivotal Phase III clinical trials, BRIO I and BRIO II, which together enrolled more than 800 adults with presbyopia.

BRIO I evaluated whether the fixed-dose combination provided greater benefit than either active ingredient alone, a regulatory requirement for approval of combination products. The study showed that the combination achieved superior near-vision improvement compared with the individual components.

BRIO II was a vehicle-controlled Phase III study designed to assess efficacy and safety over a longer period. The primary endpoint was improvement in binocular uncorrected near visual acuity, meaning the ability to read at close distances using both eyes without corrective lenses.

In this study, Yuvezzi met all primary endpoints, with a statistically significant three-line or greater improvement in near vision maintained for up to eight hours after dosing. Participants did not experience a loss of one line or more in binocular uncorrected distance visual acuity, indicating that distance vision was preserved.

Safety was assessed over more than 72,000 treatment days in BRIO II, which followed patients for up to 12 months and was described by the sponsor as the largest and longest safety study conducted to date for a presbyopia eye drop. No treatment-related serious adverse events were reported.

According to the company, Yuvezzi was designed to provide sustained pupil constriction beginning within 30 minutes and lasting up to 10 hours with a single daily dose.

In tandem with the regulatory milestone, Tenpoint announced it had secured $235 million in financing to support the commercial launch of Yuvezzi. The company said the capital will be used to advance manufacturing, distribution and commercialization, with broad US availability expected in the second quarter of 2026.

Beyond this approval, pharmacologic approaches to presbyopia continue to be evaluated. In June 2025, Viatris reported positive top-line results from a pivotal Phase III trial of phentolamine ophthalmic solution, a once-daily topical therapy being studied for improving near vision in adults with presbyopia. The study showed a meaningful improvement in near-vision while maintaining distance vision.

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