WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has approved marketing of the Essilor Stellest eyeglass lenses, the first glasses designed to both correct and slow the progression of myopia, or nearsightedness, in children ages 6 to 12.
The authorization, announced September 25, allows Essilor of America Inc. to introduce the lenses as a lower-risk alternative to contact lenses, the only previously approved option for slowing myopia progression in children. Unlike contacts, the Stellest lenses carry no risk of infection and may benefit children too young or unable to wear contact lenses.
The Stellest design features a clear central viewing zone surrounded by rings of tiny raised dots called peripheral lenslets, which redirect light in a way that helps reduce the eye’s tendency to elongate — a key factor in worsening myopia. Clinical trials showed promising results: a 71% reduction in prescription progression and a 53% reduction in eye elongation over two years compared to standard single-vision lenses. No serious adverse events were reported, though some users noted blur and halos while wearing the glasses.
Dr. Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, said the new lenses “bring 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.”
Myopia affects about 40% of Americans, a number projected to rise sharply in coming decades. Researchers estimate that more than half of the global population may be myopic by 2050. Left untreated, severe myopia can lead to complications such as retinal detachment, glaucoma, and cataracts.
The FDA granted the Stellest lenses Breakthrough Device designation in 2021, expediting their review. With this approval under the De Novo pathway for low- to moderate-risk devices, the agency is also setting performance and labeling requirements to ensure ongoing safety and effectiveness.
