The US Food and Drug Administration (FDA) has approved Yuvezzi (carbachol and brimonidine tartrate), a once-daily eye drop to treat presbyopia in adults.
In a news release, Dr John Hovanesian, of Harvard Eye Associates in California, said: “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.”.
The release said 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.
Previously known as Brimochol PF, the eye drop will be available in the second quarter of 2026. There were no reports of plans to launch the eye drops in Australia.
Yuvezzi was approved 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.
The release said that, in the second phase 3 study, 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).
No treatment-related serious adverse events observed in the more than 72,000 treatment days monitored in the second phase study.
The most common adverse events were headache, impaired vision, and temporary eye pain or eye irritation.
