Tenpoint Therapeutics Achieves Historic FDA Approval for YUVEZZI: First Dual-Agent Eye Drop Transforms Presbyopia Treatment

In a landmark regulatory achievement that could transform treatment for millions of Americans struggling with age-related vision loss, Tenpoint Therapeutics announced on January 28, 2026, that the FDA has approved YUVEZZI™ (carbachol and brimonidine tartrate ophthalmic solution) as the first and only dual-agent prescription eye drop for treating presbyopia in adults. This groundbreaking approval addresses a critical unmet medical need affecting approximately 128 million Americans and 2 billion people worldwide.

Revolutionary Approach to Age-Related Vision Loss

Presbyopia, the gradual loss of near vision that typically begins around age 45, has long been managed through symptomatic approaches like reading glasses, contact lenses, or surgical interventions. YUVEZZI represents a paradigm shift by offering the first pharmacological solution specifically designed to address the underlying optical challenges of presbyopia through a sophisticated dual-mechanism approach.

The therapy combines carbachol, a cholinergic agent that produces constriction of the iris sphincter and ciliary body, with brimonidine tartrate, an alpha-adrenergic agonist that blocks contraction of the iris dilator muscle. Together, these agents create a controlled pupillary constriction that generates a pinhole effect, improving near visual acuity and depth of focus while maintaining distance vision stability.

"The FDA approval of YUVEZZI represents a significant milestone for the millions of people in the U.S. living with presbyopia and its daily frustrations and challenges," said Henric Bjarke, Chief Executive Officer of Tenpoint Therapeutics. "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."

Compelling Clinical Evidence Drives Regulatory Success

The FDA's approval decision was supported by robust data from two pivotal Phase 3 clinical trials, BRIO I and BRIO II, which enrolled more than 800 patients and included what the company describes as the world's largest and longest safety study for presbyopia eye drops. The clinical program demonstrated both the efficacy and safety profile necessary for regulatory approval of a fixed-dose combination product.

In the Phase 3 BRIO I study, the combination therapy demonstrated superior benefit compared to either active ingredient alone, meeting the FDA's essential requirement for approval of fixed-dose combination products. The vehicle-controlled BRIO II study confirmed that YUVEZZI achieved all primary near vision improvement endpoints, with patients experiencing statistically significant three-line or greater improvement in binocular uncorrected near visual acuity sustained for up to eight hours.

Perhaps most importantly for long-term patient acceptance, the therapy maintained distance vision stability without the loss of one line or more in binocular uncorrected distance visual acuity. This preservation of distance vision addresses a key concern that has limited adoption of previous presbyopia treatments.

Safety Profile Addresses Historical Concerns

The BRIO II study represented the longest safety evaluation conducted in presbyopia eye drops to date, monitoring more than 72,000 treatment days over 12 months with no treatment-related serious adverse events observed. This extensive safety database provides crucial confidence for both physicians and patients considering long-term treatment.

Notably, eye redness, a common concern with ophthalmic drops that has limited patient acceptance of previous treatments, was uncommon with YUVEZZI. In BRIO II, ocular hyperemia occurred in only 2.8% of subjects receiving YUVEZZI, compared with 10.7% in those receiving carbachol alone. The most common side effects were headache, impaired vision, and temporary eye pain or irritation, all generally mild and manageable.

Market Impact and Commercial Implications

The approval positions Tenpoint Therapeutics to compete in a substantial and growing market opportunity. With presbyopia affecting nearly all adults over 45 to some degree, and current solutions often failing to meet real-world needs, YUVEZZI addresses a market estimated to include 128 million Americans alone. The therapy is expected to become broadly commercially available in the United States in Q2 2026.

The company's successful regulatory strategy was supported by significant financial backing, including a recently announced $235 million Series B financing and credit facility specifically designed to accelerate YUVEZZI's commercialization. This funding, led by Janus Henderson, EQT Nexus, Hillhouse, and British Business Bank, demonstrates investor confidence in the therapy's commercial potential.

Broader Implications for Vision Care

YUVEZZI's approval validates the potential for pharmacological approaches to address age-related vision changes, potentially inspiring similar strategies for other vision conditions. The success of this dual-agent approach may encourage development of combination therapies for other ophthalmic conditions where single-agent treatments have shown limitations.

For eye care professionals, YUVEZZI provides a new tool that fits seamlessly into existing practice patterns while offering patients a convenient, non-invasive daily treatment option. As Dr. John Hovanesian of Harvard Eye Associates noted, "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."

The approval represents more than just a new treatment option; it signals the maturation of presbyopia as a therapeutic area worthy of dedicated drug development. For the millions of adults worldwide who have struggled with the daily frustrations of age-related near vision loss, YUVEZZI offers hope for a treatment that can restore functional vision while fitting conveniently into active lifestyles.

As Tenpoint Therapeutics prepares for commercial launch, the success of YUVEZZI could establish a new standard of care for presbyopia treatment, potentially reducing dependence on corrective lenses and improving quality of life for aging populations worldwide.