WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration has 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.
'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.
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 percent of the U.S. population, with prevalence increasing rapidly among children and adolescents. By 2050, it is estimated that more than half 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, FDA claims. These 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 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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