FDA Clears EssilorLuxottica's Groundbreaking Eyeglasses to Slow Childhood Myopia Progression

The U.S. Food and Drug Administration (FDA) has granted a landmark authorization to EssilorLuxottica for its Essilor Stellest eyeglass lenses, designed to slow the progression of myopia in children aged 6 to 12 years. This de novo clearance marks a significant advancement in the treatment of nearsightedness, a rapidly increasing condition among U.S. adolescents that is expected to affect half the world's population by 2050.

Revolutionary Lens Technology

The Essilor Stellest lenses feature an innovative design with a clear 9mm diameter central area surrounded by rings of tiny raised dots. This unique configuration is engineered to defocus peripheral light, potentially slowing eye growth and limiting myopia progression. EssilorLuxottica CEO Francesco Milleri and deputy CEO Paul du Saillant hailed the product as "one of the most highly anticipated vision care products of the last decade," emphasizing its evolution from traditional corrective lenses to a medical treatment.

In a randomized multicenter U.S. clinical trial, children using the Stellest lenses for two years demonstrated a 71% reduction in myopia progression compared to standard lenses. Additionally, the study reported a 53% reduction in eye elongation, a primary cause of nearsightedness.

Expanding Treatment Options for Childhood Myopia

The FDA's authorization of the Essilor Stellest lenses provides a new option for managing myopia in children, complementing existing treatments such as CooperVision's MiSight contact lenses, which received FDA approval in 2019. Dr. Michelle Tarver, director of the FDA's Center for Devices and Radiological Health, highlighted the importance of this development, stating, "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."

The Essilor Stellest lenses offer several advantages over contact lenses for myopia management:

1. Lower age range: Suitable for children as young as 6 years old, compared to 8 years for MiSight contact lenses.
2. Reduced risk: Eyeglasses are associated with fewer adverse events, such as infections, compared to contact lenses.
3. Broader accessibility: Provides a solution for children unable to wear contact lenses.

Industry Impact and Future Outlook

EssilorLuxottica plans to make the Essilor Stellest lenses available in the U.S. market in the coming weeks. This launch is expected to significantly impact the vision care industry, potentially shifting the paradigm for myopia management in children.

The FDA has established special controls as part of the de novo authorization, defining labeling and performance testing requirements for similar devices in the future. This move may pave the way for further innovations in myopia management, addressing a growing global health concern.

As myopia rates continue to rise, particularly among children and adolescents, the introduction of the Essilor Stellest lenses represents a crucial step in combating what EssilorLuxottica describes as a "global epidemic." By offering a non-invasive, lower-risk option for slowing myopia progression, these lenses have the potential to reduce the incidence of severe eye problems later in life, including retinal detachment, myopic maculopathy, glaucoma, and cataracts.