EssilorLuxottica Receives FDA Authorization for Myopia Control Eyeglass Lens

EssilorLuxottica has received market authorization from the U.S. Food and Drug Administration (FDA) for its Essilor Stellest spectacle lens through the De Novo pathway. The lens is the first and only eyeglass lens authorized for market in the United States that is clinically proven to slow the progression of myopia in children.

Clinical data shows the lens slowed myopia progression by an average of 71% over two years compared to single vision lenses. EssilorLuxottica, a leader in addressing the myopia epidemic, will make the Stellest lens available to U.S. eyecare professionals in the coming weeks, following its successful international rollout.

Myopia is a global health concern, with projections indicating half the world's population may have myopia by 2050, and childhood myopia is progressing rapidly. Higher degrees of myopia are often linked to severe eye pathologies later in life, highlighting the need for solutions that not only correct but also slow its development.

EssilorLuxottica has dedicated over four decades to research in this field. The Stellest lens has been successfully launched in numerous countries and is currently worn by millions of children worldwide. The FDA authorization in the U.S. marks a significant milestone in the company's mission to improve eye health and provide effective solutions to more children globally.