Carbachol and Brimonidine Tartrate Combination Eye Drop Receives FDA Approval for Presbyopia

The FDA has approved carbachol and brimonidine tartrate (Yuvezzi; Tenpoint Therapeutics, Ltd), a fixed-dose ophthalmic combination for the treatment of presbyopia—an age-related, near vision loss condition. The combination eye drop comes in 2.75%/0.1% dosing and is the first and only dual-agent eye drop for the treatment of presbyopia in adults.^1,2

“As the first FDA-approved dual-agent eye drop for presbyopia, [carbachol and brimonidine tartrate] leverages the mechanisms of carbachol and brimonidine tartrate to deliver sharp near vision with favorable tolerability,” Henric Bjarke, CEO of Tenpoint Therapeutics, said in a news release. “[Individuals] deserve treatments that not only work but also can fit conveniently into their daily lives, and [carbachol and brimonidine tartrate] 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.”¹

What are the Indications for the Carbachol and Brimonidine Tartrate Combination?

Yuvezzi combines carbachol and brimonidine tartrate, 2 FDA-approved glaucoma therapies, to treat presbyopia. Brimonidine prevents pupil dilation, while carbachol constricts the pupil.^1,2

Specifically, carbachol is a cholinergic agent that constricts the iris sphincter and ciliary body. Brimonidine tartrate, an alpha-adrenergic agonist, inhibits iris dilator muscle contraction and relaxes tonic ciliary muscle activity, improving pupil selectivity and increasing carbachol bioavailability in the aqueous humor.¹

Together, they create a “pinhole effect” that limits incoming light to centrally focused rays, improving depth of focus and sharpening both near and distant vision, particularly for near tasks.^1,2

“[Carbachol and brimonidine tartrate] 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. [Carbachol and brimonidine tartrate] was intentionally designed to deliver both efficacy and tolerability, which represents an important step forward in delivering a complete, non-invasive option for people with presbyopia,” John Hovanesian, MD, FACS, of Harvard Eye Associates in Laguna Hills, California, said in the news release.¹

Clinical Trials Supporting Carbachol and Brimonidine Tartrate Approval

Previously, a new drug application (NDA) was submitted to the FDA prior to the approval for carbachol and brimonidine tartrate for the treatment of presbyopia. The NDA was supported by positive results from the multicenter, double-masked, randomized phase 3 BRIO-I study (NCT05270863), which assessed the safety and efficacy of brimonidine tartrate and carbachol and carbachol PF topical ophthalmic solution with emmetropic phakic, an eye that possesses a natural, clear lens and has no refractive error and presbyopia.^3,4

Results from the BRIO-I study found that combination therapy was more effective than its individual components.³

In the 12-month vehicle-controlled phase 3 BRIO-II study (NCT05135286), the longest presbyopia safety study to date, carbachol and brimonidine tartrate met all primary and secondary end points, demonstrating statistically significant improvements in binocular uncorrected near visual acuity lasting up to 8 hours. The combination also improved vision without a loss of 1 or more lines of binocular uncorrected distance visual acuity.^3,5

Carbachol and brimonidine tartrate were well tolerated, with no treatment-related serious adverse events reported across more than 72,000 treatment days. The most common adverse effects were headache, impaired vision, and temporary eye pain or irritation.¹

Eye redness was not commonly reported in clinical trials of brimonidine tartrate and carbachol, with low rates of ocular hyperemia observed in both the BRIO I and BRIO II studies. In BRIO II, ocular hyperemia occurred less frequently with brimonidine tartrate and carbachol treatment at 2.8% compared with carbachol alone at 10.7%.¹

Understanding Presbyopia

Presbyopia is a natural age-related condition in which the eyes gradually lose the ability to focus on near objects. It typically becomes noticeable in the early to mid-40s and continues to progress until about age 65. Common signs include holding reading materials farther away, blurred vision at normal reading distance, and eyestrain or headaches after close-up tasks.⁶

“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,” Hovanesian said.¹

Presbyopia affects nearly 128 million US individuals and about 2 billion individuals globally. The condition also reduced the ability to adapt to varying light levels, especially in dim or low-contrast environments.¹

“Presbyopia remains a universal and progressive condition that requires individualized management strategies,” Mile Brujic, OD, FAAO, of Premier Vision Group in Bowling Green, Ohio, said in the news release. “I’m excited that I will be able to offer my patients [brimonidine tartrate and carbachol], 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, [carbachol and brimonidine tartrate] is a valuable and practical advancement.”¹

REFERENCES

1. Tenpoint Therapeutics Ltd. announces FDA approval of Yuvezzi, the first and only combination eye drop approved to treat presbyopia. News release. Tenpoint Therapeutics. 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. Brimochol PF FDA Approval Status. Drugs.com. Updated June 11, 2025. Accessed January 29, 2026. https://www.drugs.com/history/brimochol-pf.html

3. Tenpoint Therapeutics Ltd. announces submission of a new drug application for Brimochol PF for the treatment of presbyopia to the MFDS in South Korea. Tenpoint Therapeutics. November 5, 2025. Accessed January 29, 2026. https://www.businesswire.com/news/home/20251105608942/en/Tenpoint-Therapeutics-Ltd.-Announces-Submission-of-a-New-Drug-Application-for-BRIMOCHOL-PF-for-the-Treatment-of-Presbyopia-to-the-MFDS-in-South-Korea

4. Safety and Efficacy Study BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic or Pseudophakic Presbyopia. Updated October 15, 2025. Accessed January 29, 2026. https://clinicaltrials.gov/study/NCT05270863

5. Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia. Updated August 6, 2025. Accessed January 29, 2026. https://clinicaltrials.gov/study/NCT05135286

6. Mayo Clinic Staff. Presbyopia. News release. Mayo Clinic. November 20, 2021. Accessed January 29, 2026. https://www.mayoclinic.org/diseases-conditions/presbyopia/symptoms-causes/syc-20363328