FDA approves first dual-action eye drop for age-related vision loss

3 min read Original article ↗

The US Food and Drug Administration has approved a landmark eye drop that uses a combined dose of medication to restore age-related near-sightedness, without the need for surgery, for a longer duration than anything else on the market – and with less side effects.

Known as Yuvezzi, the eyedrops developed by Tenpoint Therapeutics treat presbyopia, a very common condition that affects us with age, making it more difficult to see text and other things up close. It's now the only FDA-approved drop that combines two active ingredients – carbachol and brimonidine tartrate.

Presbyopia affects more than 100 million Americans and two billion people worldwide, with its onset generally beginning in our 40s. Mostly it's managed with reading glasses, contact lenses or invasive surgery, but until recently there hasn't been any sort of medication to help manage it.

Most recently, Vizz (aceclidine) was approved and met with a great deal of enthusiasm, giving people an alternative to the traditional hardware or surgery options. Yuvezzi, however, goes one step further, thanks to the two active ingredients. Carbachol makes your pupils smaller, which helps sharpen near vision, while brimonidine keeps those pupils small for longer, making the eyedrops more effective before another dose is required.

Its approval came after a 12-month safety study that found the drug had no serious side effects and was both safe and well tolerated. Eye redness was also reduced, compared to the drops that contain just carbachol, which will likely make it a more comfortable regular medication for some.

Yuvezzi is designed to be used daily, with a single drop in each eye. The drug works within 30 minutes, and can have a sustained effect for up to 10 hours.

“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. 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."

While Vuity has been a game-changer for treating this common condition without glasses or surgery, it generally requires a "top-up" dose during the day after three-to-six hours. Yuvezzi is trying to position itself as a “one-and-done” treatment, offering convenience and efficacy – which, when paired with tolerability scores, sounds like a game-changer. Though we'll have to wait a few more months to find out – it's expected to be available later in the second quarter of 2026.

“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.”

Source: Tenpoint Therapeutics