Biotechnology company Tenpoint Therapeutics Ltd announced on Thursday that the US Food and Drug Administration (FDA) has approved YUVEZZI (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1%, claimed to be the first and only dual-agent eye drop indicated for the treatment of presbyopia in adults.

The company expects broad commercial availability in the United States in the second quarter of 2026.

Presbyopia affects approximately two billion people globally and 128 million individuals in the United States, typically beginning around age 45.

Approval was supported by two pivotal Phase 3 trials enrolling more than 800 patients, including a 12-month safety study representing more than 72,000 monitored treatment days. In the BRIO I study, the combination therapy demonstrated superior benefit versus its individual active components, while the vehicle-controlled BRIO II trial met all primary near-vision improvement endpoints with statistically significant gains maintained over eight hours without loss of distance visual acuity. YUVEZZI achieved pupil constriction from 30 minutes up to 10 hours with one daily drop and was generally well tolerated, with the most common side effects reported as headache, impaired vision, and temporary eye pain or irritation. Reports of ocular hyperemia were low in clinical trials, with a 2.8% incidence in BRIO II compared with 10.7% for carbachol alone.