The US Food and Drug Administration has approved YUVEZZI™ (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1%, marking the first authorization of a dual-agent eye drop for the treatment of presbyopia in adults. Developed by Tenpoint Therapeutics, the therapy is expected to be commercially available in the US in the second quarter of 2026.
Presbyopia, an age-related decline in near vision that typically emerges in the mid-40s, affects an estimated two billion people worldwide and approximately 128 million in the United States. Current management options — including spectacles, contact lenses, and surgical approaches — can be effective but do not always meet patient expectations for convenience or flexibility. Pharmacologic options have therefore become an area of growing clinical interest.
YUVEZZI combines carbachol, a cholinergic agent, with brimonidine tartrate, an alpha-adrenergic agonist, in a once-daily formulation designed to induce pupil constriction and a pinhole effect, improving near visual acuity while maintaining distance vision. According to Tenpoint, the product was intentionally designed to balance durability, tolerability, and safety.
FDA approval was supported by data from two Phase 3 clinical trials, BRIO I and BRIO II, enrolling more than 800 patients. In BRIO I, the fixed-dose combination demonstrated superiority over its individual active components, a regulatory requirement for combination therapies. In the vehicle-controlled BRIO II trial, YUVEZZI met all primary endpoints, achieving statistically significant improvements of three lines or more in binocular uncorrected near visual acuity for up to eight hours, without clinically meaningful loss of distance vision.
Safety findings were notable for their scale and duration. BRIO II included more than 72,000 treatment days, making it the longest safety study conducted to date for a presbyopia eye drop. No treatment-related serious adverse events were reported, and rates of ocular hyperemia were low, occurring less frequently with YUVEZZI than with carbachol alone. The most commonly reported adverse events included headache, temporary ocular irritation, and impaired vision.
Clinicians have welcomed the approval as a meaningful expansion of non-invasive presbyopia management. With its dual-mechanism approach and once-daily dosing, YUVEZZI may offer eye care professionals a new option for patients seeking pharmacologic correction of near vision without reliance on corrective lenses or surgery.
Source: Business Wire
Presbyopia, an age-related decline in near vision that typically emerges in the mid-40s, affects an estimated two billion people worldwide and approximately 128 million in the United States. Current management options — including spectacles, contact lenses, and surgical approaches — can be effective but do not always meet patient expectations for convenience or flexibility. Pharmacologic options have therefore become an area of growing clinical interest.
YUVEZZI combines carbachol, a cholinergic agent, with brimonidine tartrate, an alpha-adrenergic agonist, in a once-daily formulation designed to induce pupil constriction and a pinhole effect, improving near visual acuity while maintaining distance vision. According to Tenpoint, the product was intentionally designed to balance durability, tolerability, and safety.
FDA approval was supported by data from two Phase 3 clinical trials, BRIO I and BRIO II, enrolling more than 800 patients. In BRIO I, the fixed-dose combination demonstrated superiority over its individual active components, a regulatory requirement for combination therapies. In the vehicle-controlled BRIO II trial, YUVEZZI met all primary endpoints, achieving statistically significant improvements of three lines or more in binocular uncorrected near visual acuity for up to eight hours, without clinically meaningful loss of distance vision.
Safety findings were notable for their scale and duration. BRIO II included more than 72,000 treatment days, making it the longest safety study conducted to date for a presbyopia eye drop. No treatment-related serious adverse events were reported, and rates of ocular hyperemia were low, occurring less frequently with YUVEZZI than with carbachol alone. The most commonly reported adverse events included headache, temporary ocular irritation, and impaired vision.
Clinicians have welcomed the approval as a meaningful expansion of non-invasive presbyopia management. With its dual-mechanism approach and once-daily dosing, YUVEZZI may offer eye care professionals a new option for patients seeking pharmacologic correction of near vision without reliance on corrective lenses or surgery.
Source: Business Wire
