January 28, 2026 – Ten Point Therapeutics Co., Ltd., a global commercial biotechnology enterprise dedicated to the field of improving age-related visual function and focused on developing breakthrough therapeutic solutions, announced that the U.S. Food and Drug Administration (FDA) has approved the marketing of Yuvezzi (Carbachol and Brimonidine Tartrate Ophthalmic Solution) at a concentration of 2.75%/0.1%. Formerly known as Brimonocholine™ Sterile Ophthalmic Solution, this medication is the first and currently the only dual-action ophthalmic solution approved for the treatment of presbyopia in adults. Presbyopia, a progressive decline in near visual acuity that typically onset around the age of 45, affects approximately 2 billion people worldwide, including 128 million in the United States. Yuvezzi is expected to be fully commercially launched in the U.S. in the second quarter of 2026.

Key Product Features of Yuvezzi

Yuvezzi (Carbachol and Brimonidine Tartrate Ophthalmic Solution) at 2.75%/0.1% is the only dual-action ophthalmic solution specifically developed for presbyopia correction, balancing long-lasting efficacy, tolerability and medication safety.

Yuvezzi’s clinical development program included two pivotal Phase 3 studies, enrolling more than 800 patients. One of these is the world’s largest and longest-running safety study of an ophthalmic solution for presbyopia.

Administered once daily, Yuvezzi induces pupillary miosis within 30 minutes, with therapeutic effects persisting for up to 10 hours.

Basis for Yuvezzi’s Approval

The FDA’s approval of Yuvezzi is based on positive data from two Phase 3 clinical trials. Phase 3 BRIO I demonstrated that this fixed-dose combination product had significantly superior efficacy compared to its individual monocomponents—a core requirement for the FDA’s approval of fixed-dose combination pharmaceuticals. BRIO II, a vehicle-controlled Phase 3 study, showed that Yuvezzi met all primary efficacy endpoints for near visual acuity improvement. In addition, Yuvezzi was well-tolerated: BRIO II, the longest-running clinical trial for presbyopia to date with a 12-month follow-up period, recorded no treatment-related serious adverse events over more than 72,000 treatment days monitored. The most common adverse reactions to Yuvezzi include headache, visual disturbances, and transient ocular pain or irritation.

Ocular redness is not a common adverse reaction associated with Yuvezzi in clinical trials. The incidence of ocular hyperemia-related adverse events was low in both BRIO I and BRIO II. Specifically, BRIO II data showed that the reported rate of ocular hyperemia in the Yuvezzi treatment group was only 2.8%, significantly lower than the 10.7% rate observed with carbachol monotherapy.

About Presbyopia

Presbyopia refers to the progressive loss of near visual acuity, typically starting at around 45 years of age, and it significantly impacts the visual function and quality of life of older adults. A natural and inevitable physiological change associated with human aging, presbyopia affects approximately 128 million people in the United States and 2 billion individuals globally. The pathogenesis of presbyopia involves a decline in the accommodative capacity of the crystalline lens, which loses its ability to flex and focus on near objects. Additionally, patients experience reduced adaptability to varying ambient light conditions, with particularly pronounced visual difficulties in dim light or low-contrast environments.

About Yuvezzi (2.75%/0.1% Carbachol and Brimonidine Tartrate Ophthalmic Solution)

Yuvezzi (2.75%/0.1% Carbachol and Brimonidine Tartrate Ophthalmic Solution) is an FDA-approved dual-action ophthalmic solution for the treatment of presbyopia, indicated for age-related decline in near visual acuity in adults aged 45 and above.

The fixed-dose combination exerts its therapeutic effect for presbyopia by constricting the pupil to create a pinhole effect, thereby enhancing near visual acuity and depth of field. Carbachol, a cholinergic agent, contracts the iris sphincter muscle and ciliary body. Brimonidine tartrate, an alpha-adrenergic agonist, inhibits the contraction of the iris dilator muscle and relieves tonic contraction of the ciliary muscle—this synergistically enhances the selective pupillary constrictor effect and increases the bioavailability of carbachol in the aqueous humor.

Indications and Important Safety Information for Yuvezzi

Indications

Yuvezzi (2.75%/0.1% Carbachol and Brimonidine Tartrate Ophthalmic Solution) is a prescription medication indicated for the treatment of age-related blurred near vision (presbyopia) in adults.

Important Safety Information

Yuvezzi is contraindicated in patients with a known hypersensitivity to any component of the formulation and in patients with active iritis.

Patients should inform their healthcare provider if they have a history of depression, hypotension, or cardiovascular disease prior to using Yuvezzi.

Yuvezzi may cause transient blurred vision, dimming of vision, or darkening of vision. Patients experiencing these symptoms should avoid driving, operating machinery, and engaging in hazardous activities; extra caution is advised when driving at night or performing activities in low-light conditions.

Patients should seek immediate medical attention if they experience sudden flashes of light, floaters, or loss of vision.

When administering the drops, do not allow the tip of the medication bottle to contact the eye, eyelid, or any other surface.

The most common adverse reactions to Yuvezzi include headache, visual disturbances, and transient ocular pain or irritation. This is not a complete list of all potential adverse reactions associated with Yuvezzi.