Tenpoint Therapeutics has received FDA approval for YUVEZZI, the first dual-agent prescription eye drops for presbyopia in adults, supported by Phase 3 BRIO I and BRIO II trial results showing significant near vision improvement with favourable tolerability.
Written By: Pharmacally Medical News Desk
Tenpoint Therapeutics, Ltd., a biotechnology company focused on improving vision in the aging eye, announced that the U.S. Food and Drug Administration (FDA) has approved YUVEZZI™ (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1% for the treatment of presbyopia in adults. The approval introduces the first and only FDA-approved dual-agent prescription eye drop designed specifically to address age-related blurry near vision.
Tenpoint Therapeutics noted that YUVEZZI is expected to become broadly commercially available across the United States in Q2 2026, positioning it as an important upcoming entrant into the expanding presbyopia treatment landscape.
Henric Bjarke, Chief Executive Officer of Tenpoint Therapeutics, described the approval as a milestone for people managing the daily frustrations of presbyopia. He emphasized that YUVEZZI combines the complementary mechanisms of carbachol and brimonidine tartrate to deliver sharper near vision with favourable tolerability.
Phase 3 Data
The FDA decision was supported by positive results from two Phase 3 clinical trials, BRIO I and BRIO II, which evaluated the safety and efficacy of the fixed-dose combination in adults with presbyopia.
In the Phase 3 BRIO I study (NCT05270863) the combination therapy demonstrated superior benefit compared with either active ingredient alone, meeting an essential FDA requirement for approval of fixed-dose combination products.
The second trial, BRIO II (NCT05135286), was vehicle-controlled and confirmed that YUVEZZI achieved all primary near vision improvement endpoints. Patients treated with YUVEZZI experienced statistically significant gains of three lines or greater in binocular uncorrected near visual acuity (BUNVA), with benefits sustained for up to eight hours, while maintaining distance vision stability.
Long-Term Safety Profile
BRIO II also represented the longest safety study conducted in presbyopia eye drops to date, covering more than 72,000 treatment days over 12 months. No treatment-related serious adverse events were reported.
YUVEZZI was generally well tolerated, with the most commonly observed side effects including headache, temporary impaired vision, and mild eye irritation or discomfort. Eye redness, a frequent concern with ophthalmic drops, was uncommon. In BRIO II, ocular hyperemia occurred in only 2.8% of subjects receiving YUVEZZI, compared with 10.7% in those receiving carbachol alone.
John Hovanesian, M.D., of Harvard Eye Associates, also highlighted that existing presbyopia solutions often fail to meet real-world needs. He noted that YUVEZZI offers a once-daily, non-invasive approach that was intentionally designed to balance efficacy with long-term comfort throughout the day.
Dual-Mechanism Eye Drop
YUVEZZI works through pupillary constriction, creating a pinhole-like optical effect that enhances depth of focus and improves near visual acuity.
Carbachol, a cholinergic agent, induces constriction of the iris sphincter and ciliary body. Brimonidine tartrate, an alpha-adrenergic agonist, blocks iris dilator activity and improves selectivity for the pupil. Together, the combination supports sustained near vision improvement while maintaining tolerability.
Presbyopia is a common and progressive condition that typically begins after the age of 45, making it harder for people to focus on close-up tasks such as reading, using smartphones, or working on computers. The condition is considered a natural part of aging and affects nearly 128 million people in the United States and about 2 billion people worldwide. While glasses, contact lenses, and surgical approaches remain widely used, many adults continue to seek a convenient, non-invasive daily treatment option.
References
Tenpoint Therapeutics Ltd. Announces FDA Approval of YUVEZZITM, the First and Only Combination Eye Drop Approved to Treat Presbyopia, 28 January 2026, https://tenpointtherapeutics.com/wp-content/uploads/2026/01/Tenpoint-Therapeutics-Receives-US-FDA-Approval-YUVEZZI_Final_1_28_26.pdf
Safety and Efficacy Study BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic or Pseudophakic Presbyopia, ClinicalTrials.gov ID NCT05270863, https://clinicaltrials.gov/study/NCT05270863
Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects with Emmetropic Phakic and Pseudophakic Presbyopia, ClinicalTrials.gov ID NCT05135286, https://clinicaltrials.gov/study/NCT05135286