FDA approves combination therapy for blurry vision

The FDA has approved Yuvezzi (carbachol and brimonidine tartrate), a once-daily eye drop to treat presbyopia in adults. Presbyopia is the loss of ability to focus on near objects as a result of the natural aging process. It occurs mostly after the age of 40 when the crystalline lens of the eye gradually stiffens and loses flexibility. Almost 2 billion people globally and more than 120 million people in the United States live with presbyopia.

“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,” John Hovanesian, M.D., FACS, of Harvard Eye Associates in Laguna Hills, Calif., said in a news release.

Yuvezzi, which was developed by Tenpoint Therapeutics, is the first combination product to treat presbyopia. It contains carbachol, a cholinergic agonist that mimics the neurotransmitter acetylcholine, and brimonidine tartrate, which is available as a generic to lower pressure inside the eye.

Yuvezzi, previously known as Brimochol PF, will be available in the second quarter of 2026. A spokesperson for Tenpoint said Yuvezzi will be priced in line with other currently available eye drops and can be covered by flexible spending accounts (FSA) and health savings accounts (HSA) funds even though it is not directly covered by insurance.

Last year, the FDA approved a single-agent therapy, VIZZ (acedidine), a once-daily eye drop for adults with presbyopia. The manufacturer, LENZ Therapeutics, sells VIZZ directly to patients or through Amazon Pharmacy for $79 a month or $198 for three months.

The FDA approval of Yuvezzi is based on positive data from two phase 3 studies. The phase 3 BRIO I study demonstrated the benefit of the combination therapy over the individual components, which is a requirement for FDA approval of a fixed-dose combination.

In the second phase 3 study, BRIO II, which was vehicle-controlled, Yuvezzi achieved all primary near vision improvement endpoints with statistically significant three-line or greater improvement in binocular uncorrected near visual acuity (BUNVA) over eight hours, without the loss of one line or more in binocular uncorrected distance visual acuity (BUDVA). BUNVA and BUDVA are two measures to assess vision using both eyes without glasses.

Yuvezzi was well-tolerated with no treatment-related serious adverse events observed in the more than 72,000 treatment days monitored in BRIO II. The most common adverse events were headache, impaired vision, and temporary eye pain or eye irritation.

In both trials, the reports of adverse events of ocular hyperemia (eye redness) were low. In BRIO II, the rate of reported eye redness was lower in patients receiving Yuvezzi than in those receiving carbachol alone.

Tenpoint Therapeutics also announced it has secured $235 million through a Series B preferred stock financing and a credit facility.