FDA Authorizes Innovative Glasses to Protect Children’s Vision

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The U.S. Food and Drug Administration (FDA) has authorized the marketing of Essilor Stellest eyeglass lenses, a new treatment option for children ages 6 to 12 with myopia (nearsightedness), with or without astigmatism. These innovative lenses not only correct vision but also slow the progression of myopia — a chronic eye condition that is becoming increasingly common in children.

Myopia is on the rise worldwide. The National Eye Institute reports that about 41.6% of the U.S. population is currently affected, and by 2050, nearly half of the world’s population could become myopic. In children, untreated myopia can worsen quickly, raising the risk of serious eye conditions later in life, such as retinal detachment, glaucoma, cataracts and myopic maculopathy.

Until now, the only FDA-approved device to slow myopia progression was a type of contact lens for children ages 8 to 12. Essilor Stellest eyeglass lenses expand treatment options to younger children as early as age 6 and to those who may not be ready or able to wear contact lenses. Eyeglasses also pose fewer risks compared with contact lenses, which can sometimes cause infections.

“As a practicing ophthalmologist, I see firsthand the lifelong impact that vision problems can have on an individual,” said Center for Devices and Radiological Health Director Michelle Tarver, M.D., Ph.D. “[The] 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 [the] risk than the currently authorized devices that slow the progression of myopia in children.”

The Stellest lenses use a unique design: a clear central zone surrounded by rings of tiny raised dots called peripheral lenslets. These lenslets alter how light enters the eye, creating a “peripheral light defocus” that helps slow eye growth, the main driver of myopia progression.

Clinical studies showed impressive results: a 71% reduction in myopia progression and a 53% reduction in eye elongation over two years compared with standard single-vision lenses. Side effects were minimal, though some children reported blur or halos.

This FDA authorization provides families with a safe, effective and child-friendly tool to manage myopia and protect long-term vision health.