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EssilorLuxottica : 24-Month U.S. Clinical Trial Results Supporting FDA De Novo Market Authorization of Essilor Stellest Lenses* Published in JAMA Ophthalmology

EssilorLuxottica : 24-Month U.S. Clinical Trial Results Supporting FDA De Novo Market Authorization of Essilor Stellest Lenses* Published in JAMA

Essilorluxottica SaAugust 27, 20265
EssilorLuxottica : 24-Month U.S. Clinical Trial Results Supporting FDA De Novo Market Authorization of Essilor Stellest Lenses* Published in JAMA Ophthalmology

About this update from Essilorluxottica Sa

Paris, France (27 August 2026) - EssilorLuxottica today announced the publication of the 24-month results from the U.S. clinical trial evaluating Essilor Stellest lenses* in JAMA Ophthalmology, a leading international peer-reviewed journal dedicated to advancing ophthalmology and visual science. This marks the first peer-reviewed publication of results from the U.S. randomized clinical trial that supported FDA De Novo marketing authorization of Essilor Stellest spectacle lenses*, the first and only U.S. FDA market authorized spectacle lenses to slow myopia progression in children. 1 The multicenter, double-masked, randomized clinical trial enrolled 159 myopic children aged 6-12 years across nine clinical sites in the United States. It evaluated the safety and effectiveness of spectacle lenses with highly aspherical lenslets (HAL) compared with single vision lenses over 24 months. Key findings from the 24-month study show that Essilor Stellest lenses*: • slowed myopia progression by 71% (0.64D) on average over 2 years †2 • slowed axial elongation by 53% (0.24mm) on average over 2 years †2 • demonstrated a well-tolerated safety profile and visual performance comparable to single vision lenses. The findings align with previous international studies , and extend the peer-reviewed evidence for this technology to a U.S. pediatric population. The publication represents an important milestone in the clinical evidence supporting Essilor Stellest lenses and reflects EssilorLuxottica's ongoing commitment to advancing evidence-based myopia management through high-quality clinical research. Read the publication here . Notes *Essilor® Stellest® lens regulatory status and product availability may vary by country. Data presented may be derived from one or more clinical studies. U.S. FDA authorization and indications for use are based solely on clinical trial data from the U.S. † Compared to single vision lenses. Results from a prospective, randomized, double masked, multicenter U.S. clinical trial in myopic children aged 6-12 years at initiation of treatment. 1. U.S. FDA. FDA authorizes marketing of first eyeglass lenses to slow progression of pediatric myopia. Sep 2025. https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-eyeglass-lenses-slow-progression-pediatric-myopia 2. Shen J, Hunt C, Young G, Drobe B. Spectacle lenses with highly aspherical lenslets for myopia control: a randomized clinical trial. JAMA Ophthalmol. Published online August 20, 2026. doi:10.1001/jamaophthalmol.2026.3288. DOWNLOAD THE PRESS RELEASE

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