FDA Approves Carbachol and Brimonidine Tartrate Ophthalmic Solution for Presbyopia

The US Food and Drug Administration (FDA) has approved carbachol and brimonidine tartrate ophthalmic solution (Yuvezzi, previously known as Brimochol PF) eye drops for the treatment of presbyopia in adult patients.1

Announced by parent company Tenpoint Therapeutics on January 28, 2026, the approval is based on positive data from the phase 3 BRIO I and BRIO II studies, which demonstrated the efficacy of carbachol and brimonidine tartrate ophthalmic solution in improving binocular uncorrected near visual acuity (BUNVA), as well as its superiority to combination therapy.1

With this decision, Yuvezzi is the first and only dual-agent eye drop approved for presbyopia. The mechanism of action central to this treatment is pupillary constriction and the creation of a pinhole effect, which improves near visual acuity and depth of focus. Carbachol, a cholinergic agent, produces constriction of the iris sphincter and ciliary body, while alpha-adrenergic agonist brimonidine tartrate prevents contraction of the iris dilator muscle and relaxes tonic contraction of the ciliary muscle.1

“The impact of presbyopia is often underestimated, and current solutions like glasses, contacts, or surgery have fallen short in meeting the real-world needs of people who struggle with close-up tasks,” John Hovanesian, MD, of Harvard Eye Associates, said in a statement. “Yuvezzi introduces a novel approach by combining carbachol and brimonidine tartrate in a single daily eye drop that sharpens near vision and maintains tolerability throughout the day.”1

BRIO I was a 3-arm, multicenter, randomized, double-masked, crossover safety and efficacy study, comparing Yuvezzi to carbachol monotherapy topical ophthalmic solution and brimonidine tartrate monotherapy topical ophthalmic solution in patients with emmetropic phakic or pseudophakic presbyopia. A total of 182 patients were enrolled across 15 sites in the US.2

Yuvezzi met all primary and secondary endpoints in BRIO I, achieving a greater population with >15 ETDRS letter gain in binocular near visual acuity (BUCNVA) without a loss of ≥5 letters at distance across all investigated time points through hour 6. These effects were maintained out to 10 hours when compared with carbachol and brimonidine monotherapy. Additionally, Yuvezzi demonstrated statistical significance in the proportion of patients achieving ≥20/40 vision at near visual acuity. A statistically significant gain in distance vision of 2 letters at 8 hours versus active control was also documented.2

BRIO II was a 3-arm, multicenter, randomized, double-masked safety and efficacy study of Yuvezzi versus carbachol monotherapy and a vehicle topical ophthalmic solution. It was the company’s second phase 3 pivotal trial, investigating prespecified endpoints agreed upon with the FDA and the European Medicines Agency. A total of 629 patients were enrolled with emmetropic phakic or pseudophakic presbyopia.3

This trial included a 12-month daily dosing period, during which Yuvezzi was well-tolerated and exhibited no serious treatment-related adverse events – no tachyphylaxis was observed in either vision or pupil effect over the duration. The primary endpoint of clinically and statistically significant reductions in pupil size at all timepoints was achieved, and additional analysis showed Yuvezzi’s improvement to reading speed and patient-reported quality of life outcomes.3

“Presbyopia remains a universal and progressive condition that requires individualized management strategies,” Mile Brujic, OD, of Premier Vision Group, said in a statement. “I’m excited that I will be able to offer my patients Yuvezzi, the first-of-its-kind eye drop well-suited for long-term use. For people seeking a reliable, lifestyle-friendly solution to manage their near vision challenges in aging eyes, Yuvezzi is a valuable and practical advancement.”1

Tenpoint Therapeutics expects Yuvezzi to be broadly commercially available in the US at some point in Q2 2026.1

References

1. Tenpoint Therapeutics. Tenpoint Therapeutics Ltd. Announces FDA Approval of YUVEZZI, the First and Only Combination Eye Drop Approved to Treat Presbyopia. BusinessWire. January 28, 2026. Accessed January 29, 2026. https://www.businesswire.com/news/home/20260128284402/en/Tenpoint-Therapeutics-Ltd.-Announces-FDA-Approval-of-YUVEZZI-the-First-and-Only-Combination-Eye-Drop-Approved-to-Treat-Presbyopia

2. Tenpoint Therapeutics. Visus Therapeutics Presents Topline Clinical Data from Phase 3 Pivotal BRIO-I Trial of BRIMOCHOL PF for the Treatment of Presbyopia at Eyecelerator @ ASCRS 2023. BioSpace. May 4, 2023. Accessed January 29, 2026. https://www.biospace.com/visus-therapeutics-presents-topline-clinical-data-from-phase-3-pivotal-brio-i-trial-of-brimochol-pf-for-the-treatment-of-presbyopia-at-eyecelerator-ascrs-2023

3. Tenpoint Therapeutics. Tenpoint Therapeutics Announces Positive Topline Data from Phase 3 Pivotal Study, BRIO-II, of BRIMOCHOL PF for the Treatment of Presbyopia. BusinessWire. January 9, 2025. Accessed January 29, 2026. https://www.businesswire.com/news/home/20250109824922/en/Tenpoint-Therapeutics-Announces-Positive-Topline-Data-from-Phase-3-Pivotal-Study-BRIO-II-of-BRIMOCHOL-PF-for-the-Treatment-of-Presbyopia