FDA

FDA greenlights Yuvezzi drops for presbyopia

February 2, 2026

Brand name: Yuvezzi

Generic name: carbachol and brimonidine tartrate ophthalmic solution

Manufacturer: Tenpoint Therapeutics

Approval date: January 28, 2026

FDA has approved Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1%, previously known as Brimochol PF, for the treatment of presbyopia in adults.

Yuvezzi is a combination of carbachol, a cholinergic agonist, and brimonidine, an alpha-adrenergic receptor agonist.

Efficacy

FDA approval was based on results from two phase 3 trials. In the BRIO I study (NCT05270863), the combination therapy demonstrated superiority over each individual component, meeting FDA’s requirement for fixed-dose combinations. In the second phase 3 trial, BRIO II (NCT05135286)— a vehicle‑controlled study—Yuvezzi met all primary near‑vision endpoints, delivering statistically significant three‑line or greater improvements in binocular uncorrected near visual acuity (BUNVA) for up to 8 hours, while maintaining binocular uncorrected distance visual acuity (BUDVA) without any one‑line loss.

Safety

Yuvezzi demonstrated a favorable safety profile. Across more than 72,000 treatment days in BRIO II no treatment‑related serious adverse events were reported. The most commonly observed adverse effects included headache, impaired vision, and temporary eye discomfort or irritation.

Sources:

Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220142s000lbl.pdf Revised January 2026. Accessed January 30, 2026.

Tenpoint Therapeutics Ltd. announces FDA approval of Yuvezzi™, the first and only combination eye drop approved to treat presbyopia. [News release]. https://tenpointtherapeutics.com/wp-content/uploads/2026/01/Tenpoint-Therapeutics-Receives-US-FDA-Approval-YUVEZZI_Final_1_28_26.pdf