FDA Approves Youweize Combination Ophthalmic Solution for the Treatment of Presbyopia in Adults

February 5, 2026 (Thursday) – The U.S. Food and Drug Administration (FDA) has approved the marketing of Youweize (Carbachol/Brimonidine Tartrate) Ophthalmic Solution at a concentration of 2.75%/0.1%, formerly known as Brimonidine-Carbachol Sterile Ophthalmic Solution. This drug is the first and currently the only dual-component combination ophthalmic solution approved for the treatment of presbyopia in adults.

Basis for This Approval

The approval is based on positive clinical data from two phase 3 trials, which enrolled a total of over 800 subjects. As a fixed-dose combination formulation, Youweize demonstrated superior therapeutic efficacy compared to single active ingredients in the phase 3 BRIO I trial. Results from another phase 3 trial, BRIO II, showed that compared with the vehicle control group, Youweize met all primary endpoints for near visual acuity improvement within 8 hours – specifically, the uncorrected near visual acuity of subjects’ both eyes improved by 3 or more lines, with no decrease of 1 or more lines in their uncorrected distance visual acuity.

A 12-month safety follow-up conducted in the BRIO II trial indicated that Youweize was well-tolerated, with no treatment-related serious adverse events reported. The most common adverse reactions to the drug include headache, visual disturbances, as well as transient ocular pain or irritation.

Remarks from Relevant Stakeholders

Henrik Biak, Chief Executive Officer of Tyenbo Therapeutics, said in a statement: "The FDA’s approval of Youweize marks a milestone achievement for millions of American patients affected by presbyopia who experience significant daily life inconveniences as a result. As the first FDA-approved dual-component combination ophthalmic solution for the treatment of presbyopia, Youweize leverages the synergistic effect of carbachol and brimonidine tartrate to deliver clear near vision for patients while ensuring favorable treatment tolerability."

The marketing approval for Youweize has been granted to Tyenbo Therapeutics.