EssilorLuxottica has received De Novo marketing authorization from the U.S. FDA for the Essilor Stellest ophthalmic lens — the first and only spectacle lens authorized in the United States to slow the progression of myopia in children, with an average efficacy of 71% over two years compared to single-vision lenses.
The FDA granted De Novo marketing authorization to the Essilor Stellest lens, making it the first and only spectacle lens officially authorized in the United States to slow the progression of myopia in children.
Clinical studies demonstrated that Essilor Stellest slowed myopia progression by an average of 71% over two years compared with single-vision lenses, based on a prospective, randomized, double-masked clinical trial conducted in the United States.
The clinical trial included children aged 6 to 12 at the start of treatment. EssilorLuxottica indicates that the lens will be available to U.S. eyecare professionals “in the coming weeks,” following its rollout in other markets worldwide.
This authorization marks a shift from traditional corrective eyewear to medically recognized vision solutions. Following its “Breakthrough Device” designation in 2021, Stellest is entering a new phase in the clinical management of myopia.
Myopia is rising rapidly worldwide and is expected to affect nearly half of the global population by 2050, including hundreds of millions of children. In North America, it already affects over 40% of adults and roughly one in four children.
Because the FDA’s De Novo authorization positions Essilor Stellest as the first spectacle lens officially approved in the United States to slow myopia progression in children — transforming a technological innovation into a recognized health solution.
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