FDA authorizes first eyeglass lenses to slow progression of pediatric Myopia

FDA authorization was based on two years of clinical study data demonstrating that Essilor Stellest lenses significantly slowed myopia progression compared to single-vision control lenses

The U.S. Food and Drug Administration (FDA) has authorized the marketing of the Essilor Stellest eyeglass lenses, the first eyeglass lenses designed to correct myopia (nearsightedness), with or without astigmatism, and to slow the progression of the condition in children ages 6 to 12 at the start of treatment.

This landmark authorization underscores the FDA’s commitment to advancing safe, effective, and innovative medical devices that address chronic conditions early in life and support healthier futures for young Americans.

“Myopia can have lifelong consequences if left unchecked. As a practicing ophthalmologist, I see firsthand how vision problems impact individuals well into adulthood,” said Michelle Tarver, M.D., Ph.D., Director of the FDA’s Center for Devices and Radiological Health. “This authorization provides families with a treatment option that may meaningfully reduce the risk of severe vision issues later in life, while being easier to use and lower risk than currently available treatments.”

Traditionally, the only FDA-approved option to slow the progression of pediatric myopia was contact lenses, limited to children ages 8 to 12. Essilor Stellest lenses provide an important alternative, especially for younger children aged 6 to 7 or those who cannot wear contact lenses. Unlike contacts, these eyeglass lenses pose a lower risk of complications, such as eye infections.

The lenses feature a clear 9 mm central optical zone surrounded by rings of microscopic lenslets. These lenslets create peripheral light defocus, which helps slow the progression of myopia while still providing clear central vision.

FDA authorization was based on two years of clinical study data demonstrating that Essilor Stellest lenses significantly slowed myopia progression compared to single-vision control lenses. At 24 months, children wearing Stellest lenses showed a 71 per cent reduction in prescription change (spherical equivalent refraction) and a 53 per cent reduction in eye elongation (axial length). No serious adverse events were reported, though some participants experienced mild visual effects such as blur or halos.

Essilor Stellest lenses were reviewed under the FDA’s De Novo premarket pathway, which is reserved for novel, low- to moderate-risk medical devices. As part of the authorization, the FDA is establishing special controls for labeling and performance testing to ensure ongoing safety and effectiveness.

The lenses were previously granted Breakthrough Device designation in April 2021, recognizing their potential to offer a more effective treatment for a condition with serious long-term health implications.

With this authorization, Essilor of America Inc. is now cleared to market Stellest lenses in the United States, offering a groundbreaking new solution for children affected by myopia.