FDA approves Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1% for presbyopia

The FDA approval of Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1%, previously known as Brimochol PF, rings in the first and only dual-agent eye drop for the treatment of presbyopia in adults.¹ In the US, Yuvezzi is expected to be broadly commercially available in Q2 2026, with Tenpoint Therapeutics also securing $235 million through the close of its Series B stock financing and a credit facility to be utilized to accelerate commercialization of the drop, according to news releases.^1,2

“The FDA approval of YUVEZZI represents a significant milestone for the millions of people in the U.S. living with presbyopia and its daily frustrations and challenges,” said Henric Bjarke, CEO of Tenpoint Therapeutics, in the release. “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. 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 aging eye.”

Yuvezzi’s approval is based on positive data from 2 phase 3 studies (BRIO-I and BRIO-II). In the BRIO-I study, the drop “demonstrated a superior benefit of the combination therapy over the individual actives – a requirement for FDA approval of a fixed-dose combination,” according to the release. The vehicle-controlled BRIO-II, Yuvezzi achieved all primary near vision improvement end points, sporting a statistically significant improvement in binocular uncorrected near visual acuity of 3 lines or greater over 8 hours without the loss of 1 line of more in binocular uncorrected distance visual acuity. Notably, the BRIO-II study spanned over more 72,000 treatment days and was the longest safety study (12 months) conducted in presbyopia to date.¹

“We’ve been working diligently to bring Yuvezzi to the eye care community and to the millions of adults looking for the optimal solution to address their frustration with presbyopia,” said Carol Kearney, Chief Commercial Officer of Tenpoint Therapeutics. “It was important to us that we provide an option that fits seamlessly into active, social and professional lifestyles, and we intentionally designed Yuvezzi to offer the right balance of efficacy, tolerability and ease of use.”

The drop was well-tolerated with no treatment-related serious adverse events observed in both studies. Common side effects of Yuvezzi are reported to be headache, impaired vision, and temporary eye pain or eye irritation. Additionally, both studies’ reports of adverse events in ocular hyperemia were low, with the rate of ocular hyperemia in BRIO-II was lower in subjects receiving Yuvezzi (2.8%) than carbochol alone (10.7%), according to the release.¹

“What differentiates Brimochol PF from earlier presbyopia drops is the intentional use of complementary pharmacology rather than relying on a single mechanism,” Mile Brujic, OD, FAAO, told The Eye Care Network. “By pairing agents that work on both sides of pupil control, the goal is improved depth of focus with a more balanced visual experience."

“The proposed mechanism of action of the fixed-dose combination of carbachol and brimonidine in presbyopia in pupillary constriction and the creation of a pinhole effect that improves near visual acuity and depth of focus,” the release stated.¹ “Carbachol is a cholinergic agent which produces constriction of the iris sphincter and ciliary body. Brimonidine tartrate, an alpha-adrenergic agonist, blocks contraction of the iris dilator muscle and relaxes tonic contraction of the ciliary muscle, enhancing selectivity for the pupil and increasing bioavailability of carbachol in the aqueous humor.”

References

1. Tenpoint Therapeutics Ltd. Announces FDA Approval of YUVEZZI, the First and Only Combination Eye Drop Approved to Treat Presbyopia. News release. Tenpoint Therapeutics. January 29, 2026. Accessed January 29, 2026. https://tenpointtherapeutics.com/wp-content/uploads/2026/01/Tenpoint-Therapeutics-Receives-US-FDA-Approval-YUVEZZI_Final_1_28_26.pdf
2. Tenpoint Therapeutics Secures $235 Million through Series B Stock Financing and Credit Facility to Accelerate Commercialization of YUVEZZI. News release. Tenpoint Therapeutics. January 29, 2026. Accessed January 29, 2026. https://tenpointtherapeutics.com/wp-content/uploads/2026/01/Tenpoint-Therapeutics-Secures-Series-B-Funding_Final_1_28_26_945PMET.pdf