EssilorLuxottica has achieved a significant regulatory milestone with FDA market authorization for its Essilor Stellest lens, becoming the first spectacle lens clinically proven to slow myopia progression in children. The Ray-Ban owner announced plans to make the lens available to U.S. eyecare professionals in the coming weeks, following its international launch.
Addressing a Growing Public Health Challenge
Myopia represents an escalating global health concern, currently affecting approximately 40% of the U.S. population with prevalence continuing to rise, particularly among children and adolescents. The National Eye Institute projects that by 2050, more than half of the world's population may become myopic, raising significant concerns about associated complications including retinal detachment, myopic maculopathy, glaucoma, and cataracts.
"Strengthening the foundation of our nation's health begins at childhood. This authorization reflects the FDA's unwavering commitment to addressing chronic diseases and advancing safe, effective, and innovative medical devices that improve the lives of young Americans," the FDA stated in its announcement.
Clinical Evidence and Mechanism of Action
The Stellest lenses feature a distinctive design with a clear 9 mm central zone surrounded by concentric rings of tiny, raised dots known as peripheral lenslets. These lenslets create peripheral light defocus, which may help slow eye growth and subsequently reduce myopia progression.
Clinical trial results demonstrated substantial efficacy in children aged 6 to 12 years. Participants wearing Stellest lenses experienced a 71% reduction in myopia progression, measured by spherical equivalent refraction, and a 53% reduction in axial length elongation compared with children wearing single-vision control lenses over a two-year period. Importantly, no serious adverse events were reported during the trial, though some participants experienced visual disturbances such as halos and blur.
Regulatory Pathway and Safety Profile
The FDA reviewed the Stellest lenses under the De Novo premarket review pathway, designed for low- to moderate-risk devices representing novel technologies. The agency is establishing special controls for labeling and performance testing to ensure long-term safety and effectiveness.
Michelle Tarver, MD, PhD, director of the FDA's Center for Devices and Radiological Health, emphasized the clinical significance: "As a practicing ophthalmologist, I see firsthand the lifelong impact that vision problems can have on an individual. Today's authorization brings to market a treatment option that may meaningfully reduce the likelihood of severe eyesight issues later in adult life, while also being easier to use and lower risk than the currently authorized devices that slow the progression of myopia in children."
Treatment Advantages and Clinical Impact
The Essilor Stellest lenses offer particular advantages for pediatric patients who are unable or unwilling to use contact lenses. Unlike contact lenses, the eyeglass lenses carry fewer risks and are not associated with complications such as infection, making them a more accessible option for younger patients and their families.
The lenses previously received Breakthrough Device designation in April 2021, a status reserved for products that may provide more effective treatment for life-threatening or irreversibly debilitating conditions. This designation facilitated expedited development and review processes.
With this authorization, pediatric ophthalmologists and optometrists now have access to a new evidence-based tool for managing myopia progression during critical years of visual development, potentially reducing the long-term burden of high myopia and its associated complications.
