Tenpoint Therapeutics, a biotechnology company developing treatments for impaired vision, announced FDA approval of Yuvezzi as a treatment for presbyopia on January 28th, 2026. The treatment, a prescription eye drop, is indicated for adults experiencing blurry close-up vision due to age. Tenpoint expects the treatment to be commercially available in Q2 2026.
Yuvezzi is a dual-agent eye drop that is composed of a fixed-dose combination of carbachol and brimonidine. According to a company press release, the treatment is designed to constrict the patient’s pupils, creating a pinhole effect that improves near visual acuity and depth of focus. Carbachol is a cholinergic agent that causes constriction of the iris sphincter and ciliary body. Brimonidine tartrate is an alpha-adrenergic agonist that blocks contraction of the iris dilator muscle and relaxes tonic contraction of the ciliary muscle, which enhances selectivity for the pupil and increases bioavailability of carbachol in the aqueous humor.
Approval was based on results from two Phase III studies, BRIO I and BRIO II. According to the release, results from BRIO 1 demonstrated a superior benefit of Yuvezzi over the individual active ingredients, which is required for FDA approval of any fixed-dose combination. In BRIO 2, the treatment achieved all primary near vision improvement endpoints and had statistically significant improvement in binocular uncorrected near visual acuity over eight hours.
“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, 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.”
“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, Harvard Eye Associates in Laguna Hills, California, in the release. “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, non- invasive option for people with presbyopia.”
On the same day of the approval, Tenpoint also announced that it had raised a total of $235 million to support the commercialization of Yuvezzi. In addition to $85 million in Series B financing, the company also entered into a $150 million non-dilutive senior term loan facility with Hercules Capital.
“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, Tenpoint Therapeutics, in the release announcing this financing.
