WASHINGTON (WDNews) – The U.S. Food and Drug Administration has authorized marketing of the Essilor Stellest eyeglass lenses, the first glasses designed to both correct myopia and slow its progression in children ages 6 to 12 at the start of treatment.
The lenses, made by Essilor of America Inc., are intended for children with or without astigmatism. Myopia, or nearsightedness, affects about 40% of the U.S. population, with rates rising rapidly among children and adolescents. Left untreated, it can lead to severe vision problems later in life, including glaucoma, cataracts, and retinal detachment.
“Today’s authorization brings to market a treatment option that may meaningfully reduce the likelihood of severe eyesight issues later in adult life, while also being easier to use and lower risk than the currently authorized devices that slow the progression of myopia in children,” said Michelle Tarver, M.D., Ph.D., director of the FDA’s Center for Devices and Radiological Health.
Until now, the only approved option to slow myopia progression was contact lenses for children 8 to 12 years old. The new eyeglass lenses expand treatment options for younger children and those unable to wear contacts.
Clinical studies showed the Stellest lenses reduced myopia progression by 71% and slowed eye elongation by 53% over two years compared to single-vision lenses. No serious adverse events were reported, though some children noted visual symptoms such as blur or halos.
The FDA reviewed the product under its De Novo pathway for low- to moderate-risk devices. The lenses were granted Breakthrough Device designation in 2021, expediting review due to their potential impact on children’s vision health.
