Essilor’s Stellest Eyeglass Lenses Win FDA Nod to Slow Myopia Progression

The U.S. Food and Drug Administration (FDA) has granted de novo approval of the Essilor Stellest eyeglass lenses to correct myopia with or without astigmatism and to slow progression of the disease in children six to 12 years told at the beginning of treatment.

Before these eyeglasses, there was only one approved device to slow progression of myopia in the form of contact lenses, for eight to 12-year-olds. The Stellest eyeglasses can fill the gap for children six to seven years old or for children unable to wear contacts. They are a lower risk device compared to contacts and don’t have adverse events like infections that can be associated with using contact lenses.

The Stellest lenses have a clear 9 mm area in the center that’s surrounded by rings of tiny, raised dots (peripheral lenslets) on the rest of the lens. The tiny, raised dots offer peripheral light defocus, which can help slow myopia progression in children.

The FDA assessed two years of data from a clinical study showing the Stellest eyeglass lenses slowed myopia progression compared to single vision control lenses. The study measured the change in glasses prescription (spherical equivalent refraction) and the change in the length of the eye (axial length).

For spherical equivalent refraction, the study showed a 71% reduction in myopia progression at 24 months. For axial length, the study showed a 53% reduction in eye elongation at 24 months. Some subjects reported visual symptoms, such as blur and halos, while wearing the glasses.

The Stellest lenses earned Breakthrough Device designation on April 30, 2021.

“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. “[This] 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.”

In May, EssilorLuxottica purchased Optegra, a highly integrated ophthalmology platform operating in five key European markets: the United Kingdom, Czech Republic, Poland, Slovakia, and the Netherlands.