FDA Approves Yuvezzi, First Dual-Agent Eye Drop for Presbyopia
Tenpoint Therapeutics announced that the FDA has approved Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1% for the treatment of presbyopia in adults. Previously known as Brimochol PF, Yuvezzi is the first and only FDA-approved dual-agent eye drop designed to address this common age-related condition.
Yuvezzi is expected to be broadly commercially available in the US in the second quarter of 2026.
The FDA approval is supported by positive results from two phase 3 clinical trials, BRIO I and BRIO II. In BRIO I, the combination therapy demonstrated a superior benefit compared with each individual active ingredient alone, meeting the FDA’s requirement for approval of a fixed-dose combination therapy. In the second study, BRIO II, which was vehicle-controlled, Yuvezzi achieved all primary efficacy endpoints, delivering statistically significant improvements of 3 lines or more in binocular uncorrected near visual acuity (BUNVA) over an 8-hour period, without a loss of 1 line or more in binocular uncorrected distance visual acuity (BUDVA).
Yuvezzi was also shown to be well tolerated. Across more than 72,000 treatment days monitored in BRIO II—the longest safety study conducted in presbyopia to date—no treatment-related serious adverse events were observed. The most commonly reported side effects were headache, impaired vision, and temporary eye pain or irritation. Eye redness was not commonly reported, and in BRIO II the rate of ocular hyperemia was lower with Yuvezzi (2.8%) than with carbachol alone (10.7%).
“The FDA approval of Yuvezzi represents a significant milestone for the millions of people in the US 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. This approval marks the first groundbreaking therapy for Tenpoint Therapeutics as we advance our mission to bring innovation to the aging eye.”
Eye care professionals welcomed the approval as a meaningful advance in presbyopia management.
“The impact of presbyopia is often underestimated, and current solutions like glasses, contacts or surgery have fallen short in meeting real-world needs,” said John Hovanesian, M.D., FACS, of Harvard Eye Associates in Laguna Hills, California. “Yuvezzi introduces a novel approach by combining two agents in a single daily eye drop that sharpens near vision while maintaining tolerability throughout the day.”
Tenpoint Secure Funding to Support Commercialization
Tenpoint also announced that it has secured $235 million through the successful close of its Series B preferred stock financing and a credit facility. The funding will be used to accelerate the launch of Yuvezzi.
The company raised $85 million in Series B financing led by Janus Henderson, EQT Nexus, Hillhouse and British Business Bank. Existing investors also participated in the round, including EQT Life Sciences, Sofinnova Partners, F-Prime, Eight Roads, Qiming Venture Partners USA, AdBio and Wille. In addition, Tenpoint entered into a $150 million non-dilutive senior secured term loan facility with Hercules Capital.
“We deeply appreciate the support of our strong syndicate of global, long-term investors,” said Henric Bjarke, Chief Executive Officer of Tenpoint Therapeutics. “This financing reflects their confidence in Yuvezzi, a new differentiated option for millions of people living with the daily frustration and challenges of presbyopia. With our strengthened balance sheet, we are excited to launch Yuvezzi in early Q2.”
Originally published online on Eyewire+.