Eye Drops for Presbyopia Approved in the United States

The US Food and Drug Administration (FDA) has given its approval for the marketing of Yuvezzi (Tenpoint Therapeutics).

Initially known as Brimochol PF, Yuvezzi (containing 2.75% carbachol and 0.1% brimonidine tartrate) thus became the first two-component eye drop approved for the management of presbyopia in adults in the United States.

Unlike first-generation solutions based on a single agent, Yuvezzi leverages the complementary action of two molecules to influence pupillary control. This dual action increases depth of field and improves near visual acuity without compromising distance vision.

Its launch on the American market is planned for the second quarter of 2026.

Proven long-term clinical results

The approval is based on data from two phase 3 studies, BRIO-I and BRIO-II.

In the BRIO-II study, the eye drops met all of its primary endpoints. Patients showed a statistically significant improvement in uncorrected binocular near visual acuity (gain of 3 or more lines) over an 8-hour period, with no loss of lines in distance vision.

The BRIO-II study is the longest-running safety study conducted to date on presbyopia (12 months). No serious adverse events related to treatment were observed.

Tolerance and comfort

One of the differentiating factors highlighted by Tenpoint Therapeutics concerns ocular tolerance. The most frequent side effects remain typical for this class of products (headache, temporary blurred vision, mild eye pain).

However, reports of ocular hyperemia (red eye) remained low. In the BRIO-II study, the rate of hyperemia was only 2.8% for subjects receiving Yuvezzi, compared to 10.7% for those receiving carbachol alone.

“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, Chief Executive Officer of Tenpoint Therapeutics. “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.”

“The impact of presbyopia is often underestimated, and current solutions like glasses, contacts or surgery have fallen short in meeting the real-world needs of people who struggle with close-up tasks,” said John Hovanesian, M.D., FACS, of Harvard Eye Associates in Laguna Hills, California. “YUVEZZI introduces a novel approach by combining carbachol and brimonidine tartrate in a single daily eye drop that sharpens near vision and maintains tolerability throughout the day. YUVEZZI was intentionally designed to deliver both efficacy and tolerability, which represents an important step forward in delivering a complete, noninvasive option for people with presbyopia."

“Presbyopia remains a universal and progressive condition that requires individualized management strategies,” said Mile Brujic, OD, FAAO, of Premier Vision Group in Bowling Green, Ohio. “I’m excited that I will be able to offer my patients YUVEZZITM, the first-of-its-kind eye drop well-suited for long-term use. For people seeking a reliable, lifestyle-friendly solution to manage their near vision challenges in aging eyes, YUVEZZI is a valuable and practical advancement.”

“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.”

Availability

Although the US approval of Yuvezzi is now confirmed, there are no reports of plans to launch the eye drops in Australia.