Tenpoint Therapeutics announced FDA’s approval of Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1% for the treatment of presbyopia in adults, marking the first FDA-approved dual-agent eye drop for the condition.

Yuvezzi, previously known as BRIMOCHOL PF, is expected to become broadly available in the U.S. in the second quarter of 2026.¹

Presbyopia, a progressive condition typically beginning around age 45, affects an estimated 2 billion people worldwide, including an estimated 128 million in the United States.¹ The condition is caused by age-related changes in the eye’s ability to focus on near objects and can interfere with everyday tasks, particularly in low-light or low-contrast settings.

“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.”

What is Yuvezzi’s approval based on?

The agency’s approval of Yuvezzi is based on data collected from two Phase III clinical trials, BRIO I and BRIO II, which evaluated the efficacy and safety of the fixed-dose combination.¹ In BRIO I, Yuvezzi demonstrated superiority over each individual active component, meeting the FDA’s requirement for approval of combination therapies. In the vehicle-controlled BRIO II study, Yuvezzi met all primary endpoints, delivering statistically significant three-line or greater improvements in binocular uncorrected near visual acuity over an eight-hour period without a loss of one line or more in binocular uncorrected distance visual acuity.¹

Yuvezzi was generally well tolerated across its clinical programs. In BRIO II, which included more than 72,000 treatment days and represented the longest safety study conducted in presbyopia to date, no treatment-related serious adverse events were observed, but the most commonly reported side effects were headache, impaired vision, and temporary eye pain or irritation.¹

“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.”

Tenpoints’ series B stock financing

To pair with FDA’s approval of Yuvezzi, Tenpoint Therapeutics also announced it has raised a total of $235 million in new capital. This combines $85 million from a Series B preferred stock financing with a $150 million non-dilutive senior secured term loan facility, strengthening the company’s balance sheet as it advances programs targeting age-related vision loss.²

The equity round was led by Janus Henderson, EQT Nexus, Hillhouse and the British Business Bank, with participation from existing investors including EQT Life Sciences, Sofinnova Partners, F-Prime, Eight Roads, Qiming Venture Partners USA, AdBio and Wille, while the debt financing was provided by Hercules Capital.²

“It’s incredibly exciting to see the Series B financing and YUVEZZI approval align at the same moment, creating the perfect launch point for this exceptional ophthalmology team to deliver a best-in-class dual agent to this massive market,” said David Guyer M.D., chairman of Tenpoint Therapeutics.

Sources

1. Tenpoint Therapeutics Ltd. Announces FDA Approval of Yuvezzi the First and Only Combination Eye Drop Approved to Treat PresbyopiaTenpoint Therpaeutics Janurary 28, 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 Tenpoint Therapeutics Janurary 28, 2026 https://tenpointtherapeutics.com/wp-content/uploads/2026/01/Tenpoint-Therapeutics-Secures-Series-B-Funding_Final_1_28_26_945PMET.pdf