Today, the U.S. Food and Drug Administration authorized marketing of the Essilor Stellest eyeglass lenses to correct myopia, commonly referred to as nearsightedness, with or without astigmatism and to slow the progression of the disease in children 6 to 12 years old at the initiation of treatment.

Strengthening the foundation of our nation’s health begins at childhood. This authorization reflects the FDA’s unwavering commitment to addressing chronic diseases and advancing safe, effective, and innovative medical devices that improve the lives of young Americans.

“As a practicing ophthalmologist, I see firsthand the lifelong impact that vision problems can have on an individual. 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 Center for Devices and Radiological Health Director Michelle Tarver, M.D., Ph.D.

According to the National Eye Institute, several studies indicate that the prevalence of myopia is increasing in the U.S. and worldwide, and researchers project the trend will continue in the coming decades. Myopia is a chronic disease that affects approximately 40% of the U.S. population, with prevalence increasing rapidly among children and adolescents. By 2050, it is estimated that more than 50% of the world population may become myopic. When left untreated, this disease can progress to high myopia, which can significantly increase risks of sight-threatening complications, including retinal detachment, myopic maculopathy, glaucoma, and cataracts later in life.

Myopia typically progresses in school-aged children when their eyes are still growing, leveling off in early adulthood. Prior to Essilor Stellest eyeglass lenses, there was only one approved device for slowing the progression of myopia in the form of contact lenses, for 8 to 12-year-olds. The Essilor Stellest eyeglass lenses can fill the gap for children 6 to 7 years old or for children who are unable to wear contacts. These Essilor Stellest eyeglass lenses are a lower risk device compared to contact lenses and do not have adverse events (such as infections) that may be associated with the use of contact lenses.

The Essilor Stellest eyeglass lenses have a clear 9mm diameter area in the center, which is surrounded by rings of tiny, raised dots (peripheral lenslets) on the rest of the lens. The tiny, raised dots provide peripheral light defocus, which may help to slow the progression of myopia in children.

The FDA evaluated two-years of data from a clinical study that demonstrated the Essilor Stellest eyeglass lenses slowed myopia progression as 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. There were no serious adverse events reported in the clinical study. However, some subjects did report visual symptoms, such as blur and halos, while wearing the Essilor Stellest eyeglass lenses. There are no labeled contraindications.

The FDA reviewed the Essilor Stellest eyeglass lenses through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for this device type.

The FDA granted Breakthrough Device designation for the Essilor Stellest eyeglass lenses on April 30, 2021. A breakthrough designation is meant to expedite the development and review of devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

The FDA granted marketing authorization of the Essilor Stellest lenses via the De Novo premarket review pathway to Essilor of America Inc.

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