World
EssilorLuxottica: Essilor Stellest is the first and only FDA market authorized spectacle lens in the United States
Essilor Stellest is the first and only FDA market authorized spectacle lens in the United States EssilorLuxottica’s lens is clinically proven to slow myopia progression in children1,2 Paris, France (25 September 2025) – EssilorLuxottica today announced the U.S. Food and Drug Administration (FDA) has granted market authorization for its Essilor Stellest lens using the De Novo pathway. This follows the product’s earlier recognition with the FDA granting designation as a Breakthrough Device in 2021
About this update from Essilorluxottica Sa
[{"type":"image","alt":"EssilorLuxottica","displaySize":"","headline":null,"caption":"EssilorLuxottica","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":33,"url":"https://media.zenfs.com/en/globenewswire.com/917e4a586fd01b9ae482d2ec9b2b8eb5"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/NyPhKYW6.EAnTgAoI_btNQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTQ2O2NmPXdlYnA-/https://media.zenfs.com/en/globenewswire.com/917e4a586fd01b9ae482d2ec9b2b8eb5","width":300,"height":33}},"lazy":false},{"type":"text","content":"Essilor Stellest is the first and only FDA market authorized spectacle lens in the United States","length":97,"tagName":"p"},{"type":"text","content":" EssilorLuxottica’s lens is clinically proven to slow myopia progression in children1,2","length":86,"tagName":"p"},{"type":"text","content":"Paris, France (25 September 2025) – EssilorLuxottica today announced the U.S. Food and Drug Administration (FDA) has granted market authorization for its Essilor Stellest lens using the De Novo pathway. This follows the product’s earlier recognition with the FDA granting designation as a Breakthrough Device in 2021. The Essilor Stellest lens is the first-ever FDA market authorized spectacle lens clinically proven to slow myopia progression in children1,2. The effectiveness of the Essilor Stellest lens is evidenced by clinical data showing that the lens slowed down myopia progression by 71% on average over two years1,2. Leading the global effort to address the myopia epidemic, EssilorLuxottica will make the Essilor Stellest lens available in the coming weeks for U.S. eyecare professionals to equip children following its successful international roll-out.","length":865,"tagName":"p"},{"type":"text","content":"“The Essilor Stellest lens has been one of the most highly anticipated vision care products of the last decade. Facing a global epidemic that impacts millions of lives, we set out years ago to develop a lens that would truly answer the needs of the market, particularly the next generation. This lens technology evolves the traditional corrective lenses into a true medical treatment, and it marks the beginning of a new era for eyecare professionals in addressing myopia. We are thrilled to have been granted FDA’s market authorization for Essilor Stellest in the U.S., bringing it to young patients in need. As we continue to redefi...