US EditionFDA Authorizes First Eyeglass Lenses to Slow Nearsightedness in Children in the US
Essilor Stellest lenses reduce myopia progression by 71% in children aged 6 to 12, offering a safer, easier option to prevent serious eye complications later in life.
- On Thursday, the U.S. Food and Drug Administration authorized Essilor Stellest eyeglass lenses for children ages 6 to 12 with myopia in the United States.
- Rising myopia rates show growing prevalence among children and adolescents, raising risks of retinal detachment, myopic maculopathy, glaucoma, and cataracts, with early intervention critical at the optimal treatment moment, the FDA said.
- Clinical trial results showed Stellest lenses reduced myopia progression by 71% in spherical equivalent refraction and 53% in axial length over 24 months versus single-vision control lenses, with no serious adverse events reported though some experienced visual disturbances such as halos and blur.
- U.S. practitioners can now offer Stellest lenses as a new option to slow myopia progression in children, with the FDA saying it may reduce severe eyesight issues later, Tarver said.
- The Stellest design features a clear center with peripheral raised-dot rings to manipulate peripheral retina image quality, while the National Institutes of Health awarded $25 million grants for daily atropine drops research in children ages 6 to 11.
35 Articles
35 Articles
FDA authorizes Essilor Stellest spectacle lenses for myopia control
The FDA has authorized marketing of Essilor Stellest spectacle lenses by EssilorLuxottica, allowing the first eyeglass lenses capable of slowing pediatric myopia progression to be sold in the U.S.The lenses were approved through the FDA’s de novo premarket review pathway after being granted breakthrough device designation in April 2021.
FDA authorizes first eyeglass lenses to slow nearsightedness in children in the US
The US Food and Drug Administration has authorized marketing of the first eyeglass lenses that not only correct nearsightedness in children, they can slow the progression of the condition.
MedPage Today
Anti-Aging, Acupuncture and Health NewsFirst Approval of Eyeglass Lenses for Children With Myopia
(MedPage Today) -- The FDA granted a first-ever market authorization for eyeglass lenses for children with myopia, or nearsightedness, the agency announced Thursday. The approval of the Essilor Stellest lenses with highly aspherical lenslets ...
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