Tenpoint Therapeutics Announces FDA Approval of YUVEZZI™, the First Combination Eye Drop for Presbyopia

Tenpoint Therapeutics recently announced that the U.S. FDA has approved Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution, 2.75%/0.1%) for the treatment of presbyopia in adults. According to the press release,Yuvezzi is the first dual-drug compound eye drop approved for the treatment of presbyopia.Yuvezzi adopts a once-daily dosing regimen, producing miosis within 30 minutes of administration and lasting for 10 hours, thereby improving near vision.

Presbyopia is a phenomenon of gradual decline in near vision, typically beginning around the age of 45, and significantly impacting the quality of life and visual function of elderly individuals. Presbyopia is a natural and inevitable part of the aging process, affecting approximately 2 billion people worldwide. It weakens the ability of the lens to change shape and focus on nearby objects, and also makes it difficult to adapt to different levels of ambient light, especially under dim or low-contrast conditions.

Yuvezzi's FDA approval was primarily based on positive data from two pivotal Phase 3 studies, which together enrolled over 800 patients. The Phase 3 BRIO I study demonstrated that this combination therapy offered superior benefits compared to single active ingredients, a key requirement for FDA approval of fixed-dose combination drugs. In the second vehicle-controlled Phase 3 study, BRIO II,Yuvezzi Achieves All Primary Near Vision Improvement Endpoints Within 8 Hours, with a Statistically Significant Three-Line or Greater Improvement in Binocular Uncorrected Near Visual Acuity (BUNVA), While No Loss of One Line or More in Binocular Uncorrected Distance Visual Acuity (BUDVA).

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Moreover, no treatment-related serious adverse events were observed over more than 72,000 treatment days monitored in the BRIO II study, and Yuvezzi was generally well-tolerated. According to the press release, this study is also the longest safety study conducted in the field of presbyopia to date (12 months).YuvezziThe most common adverse reactions include headache, impaired vision, and transient eye pain or eye irritation.

In the clinical trial of Yuvezzi,Eye congestion (Eye redness is not a common adverse reaction. In the BRIO I and BRIO II studies, the incidence of adverse events related to eye congestion was low. In BRIO II, the reported rate of eye congestion in subjects treated with Yuvezzi was 2.8%, lower than the 10.7% in the carbachol-only group.

Yuvezzi (formerly known as Brimochol PF) is a dual-drug compound eye drop.The mechanism of action of this fixed-dose combination eye drop in presbyopia is to improve near vision and depth of field by inducing miosis to create a "pinhole effect."Carbachol is a cholinergic drug that can induce the contraction of the iris sphincter and ciliary body. Brimonidine tartrate is an α-adrenergic agonist that can block the contraction of the iris dilator muscle and relax the tonic contraction of the ciliary muscle, thereby enhancing the selectivity for the pupil and increasing the bioavailability of carbachol in the aqueous humor.

References:

[1] Tenpoint Therapeutics Ltd. Announces FDA Approval of YUVEZZI™, the First and Only Combination Eye Drop Approved to Treat Presbyopia. Retrieved January 29, 2026 from 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

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