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. 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.
“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 redefine the future of technology, eye health and human connection, this groundbreaking innovation is a major milestone on our mission to empower people and allow them to greater control their health destiny,” said Francesco Milleri, Chairman and CEO, and Paul du Saillant, Deputy CEO of EssilorLuxottica.
EssilorLuxottica has been leading research in this field for more than four decades, culminating in the launch of the Essilor Stellest lens in key countries across the world, with the lens now being worn by millions of children. In line with EssilorLuxottica’s efforts to develop and deliver groundbreaking medical care technology to people around the world, the Essilor Stellest lens provides eyecare professionals with an evidence-backed, reliable solution for helping families address the challenges of myopia, improving both short-term and long-term eye health outcomes.
The myopia epidemic is a global health issue, with half the world population estimated to suffer from myopia by 2050 and childhood myopia progressing at a fast pace, with 740 million children who could be affected worldwide by 2050. Higher levels of myopia are frequently associated with severe eye pathologies later in life, hence the need to provide families with solutions not only to correct myopia but also slow its progression, thanks to dedicated spectacle lenses for example. In North America, over 4 in 10 adults3 and 1 in 4 children4 - aged 6 to 19 - are affected by myopia, and studies3 show that this prevalence is accelerating over years.
Notes:
1 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.
2 Essilor International, data on file (2025)
3 Holden BA, Fricke TR, Wilson DA, et al. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016;123(5):1036-1042. doi:10.1016/j.ophtha.2016.01.006
4 Liang J, Pu Y, Chen J, et al. Global prevalence, trend and projection of myopia in children and adolescents from 1990 to 2050: a comprehensive systematic review and meta-analysis. Br J Ophthalmol. 2025;109(3):362-371. Published 2025 Feb 24. doi:10.1136/bjo-2024-325427
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