Latest Myopia News

Essilor’s Stellest Lenses Receive FDA Market Authorization

U.S. eye care professionals can expect the Essilor Stellest lenses to be available in the coming weeks. 

September 26, 2025

An image of the Essilor Stellest lens

Photo provided by EssilorLuxottica

PARIS, France — The Essilor Stellest spectacle lenses have received market authorization from the U.S. Food and Drug Administration (FDA). 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 children.1,2 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 years.1,2 Leading the global effort to address the myopia epidemic, EssilorLuxottica will make the Essilor Stellest lens available in the coming weeks for U.S. eye care professionals to equip children following its successful international roll-out.

A New Option for Myopia Management

“The Essilor Stellest lens has been one of the most highly anticipated vision care products of the last decade,” said Francesco Milleri, Chairman and CEO, and Paul du Saillant, Deputy CEO of EssilorLuxottica. “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,”

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 eye care 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.

 

References

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).

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