Tenpoint Therapeutics said its “first and only combination eye drop approved to treat presbyopia” has been approved for use in the United States.1
Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1% is the only dual agent presbyopia-correcting eye drop intentionally designed to deliver durability, tolerability, and safety, the company said.
… the solution achieves miosis from 30-minutes up to 10 hours with one drop daily
Yuvezzi was studied in two pivotal Phase 3 trials enrolling more than 800 patients, including the world’s largest and longest safety study for presbyopia eye drops.
The company said the solution achieves miosis from 30-minutes up to 10 hours with one drop daily.
The US Food and Drug Administration approval of Yuvezzi, previously known as Brimochol PF, was based on the BRIO-I and BRIO-II studies.
BRIO I study demonstrated a superior benefit of the combination therapy over the individual actives – a requirement for FDA approval of a fixed-dose combination.2
In BRIO II, which was vehicle-controlled, Yuvezzi achieved all primary near vision improvement endpoints with statistically significant three-lines or greater improvement in binocular uncorrected near visual acuity (BUNVA) over eight hours, without the loss of one line or more in binocular uncorrected distance visual acuity (BUDVA).3
Yuvezzi was well-tolerated with no treatment-related serious adverse events observed in the more than 72,000 treatment days monitored in BRIO II. The most common side effects of Yuvezzi are headache, impaired vision, and temporary eye pain or eye irritation.4
“As the first FDA-approved dual-agent eye drop for presbyopia, Yuvezzi leverages the mechanisms of carbachol and brimonidine tartrate to deliver sharp near vision with favorable tolerability,” said Henric Bjarke, Chief Executive Officer of Tenpoint Therapeutics.
“People deserve treatments that not only work but also can fit conveniently into their daily lives, and Yuvezzi brings an innovative new option to the presbyopia category.
“This approval marks the first groundbreaking therapy for Tenpoint Therapeutics aimed at advancing our mission to bring innovation to the ageing eye.”
References
- Tenpoint Therapeutics, Tenpoint Therapeutics Ltd. announces FDA approval of Yuvezzi, the first and only combination eye drop approved to treat presbyopia. News release. 28 Jan 2026. Available at: tenpointtherapeutics.com/wp-content/uploads/2026/01/Tenpoint-Therapeutics-Receives-US-FDA-Approval-YUVEZZI_Final_1_28_26.pdf [accessed Feb 2026].
- Tenpoint Therapeutics Ltd. BRIO-I study data on file.
- Tenpoint Therapeutics Ltd. BRIO-II study data on file.
- Yuvezzi US Prescribing Information.
