FDA OKs More Eye Drops That Can Replace Reading Glasses

 The FDA approved carbachol/brimonidine tartrate ophthalmic solution (Yuvezzi) for adults with presbyopia, making it the first approved dual-agent eye drop therapy for age-related vision decline.

The eye drops contain two active ingredients with different mechanisms of action in the eye. Other approved eye drops for presbyopia have a single active ingredient, such as pilocarpine or aceclidine (Vizz).

"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, MD, of Harvard Eye Associates in Laguna Hills, California, in a statement from the eyedrop manufacturer, Tenpoint Therapeutics. "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. [The product] represents an important step forward in delivering a complete, non-invasive option for people with presbyopia."

Principal support for the approval came from the phase III BRIO I and II trials. In BRIO I, the combination eye drops demonstrated better visual outcomes as compared with the individual components. The vehicle/topical carbachol-controlled BRIO II trial enrolled 629 patients at 47 sites in the U.S. The carbachol/brimonidine eye drops improved all near-vision endpoints, including statistically significant improvement in the primary endpoint of three-line or greater improvement in binocular uncorrected near visual acuity over 8 hours without loss of one or more lines in binocular, uncorrected distance visual acuity.

In BRIO II, the most common side effects associated with carbachol/brimonidine eye drops were headache, impaired vision, and temporary eye pain or eye irritation. Hyperemia occurred less often with the combination drops than with the carbachol ophthalmic solution (2.8% vs 10.7%).

A near-universal manifestation of aging, presbyopia affects an estimated 128 million adults in the U.S. and 2 billion worldwide. Presbyopia affects almost all adults beginning at age 45. The condition occurs as a loss of near vision that worsens over time but usually stabilizes at age 65.

Standard management continues to be reading glasses, multifocal glasses, or contact lenses. Surgical interventions may be appropriate for selected patients but has variable acceptance. No approved pharmacologic treatments existed until the FDA greenlighted pilocarpine ophthalmic solution (Vuity in 2021 and Qlosi in 2023).

https://www.medpagetoday.com/ophthalmology/generalophthalmology/119645