Essilor Stellest lenses receive FDA market authorization in the U.S.

On September 25, 2025, the U.S. Food and Drug Administration (FDA) authorized the marketing of Essilor® Stellest® lenses to both correct myopia and slow myopia progression in children with non-diseased eyes, who, at the initiation of treatment, are aged 6-12 years and have a spherical equivalent refraction of -0.75 D to - 4.50 D, and with astigmatism up to 1.50 D.1 This marks the Essilor® Stellest® lens as the first FDA-market authorized spectacle lens clinically proven to slow myopia progression in children. 

Prior to this authorization, the only approved device for slowing the progression of myopia in the U.S. was the CooperVision MiSight® 1 day soft contact lens, which received FDA approval in 2019 for children aged 8–12 years at treatment initiation.2 The introduction of Essilor® Stellest® lenses adds a spectacle-based option to the myopia management landscape in the U.S., which may be more accessible for children and for those unable to wear contact lenses. Notably, it addresses a treatment gap for children aged 6–7 years.

FDA market authorization for Essilor® Stellest® lenses was granted through the De Novo premarket review pathway, a regulatory route for new medical devices with a low- to moderate-risk profile for which no predicate device exists. This pathway allows the FDA to establish appropriate controls while enabling timely access to new treatments.

This authorization establishes Essilor® Stellest® lenses as an on-label spectacle-based intervention for myopia control in clinical practice in the U.S.

In granting marketing authorization, the FDA evaluated two-year data from the FIN-3101 three-year randomized controlled clinical trial, conducted across nine clinical sites in the United States.3

The study enrolled children aged 6 to 12 years at the initiation of treatment, with myopia ranging from −0.75 D to −4.50 D and astigmatism up to 1.50 D.  The study population was representative of the U.S. pediatric population. 

Participants were randomly assigned to wear either Essilor® Stellest® spectacle lenses or standard single vision spectacle lenses. Of the 175 children enrolled, 149 were dispensed the study lenses, and 91% (135) completed the full 24-month follow-up. The primary outcomes for analyzing treatment effectiveness were mean changes in cycloplegic spherical equivalent refraction (cSER, D) and axial length (mm).

The key findings were as follows.

• Children wearing Essilor® Stellest® lenses showed an average cSER change of −0.25 D compared with −0.90 D in the single vision group, representing a 71% reduction in myopia progression over two years.
• Children wearing Essilor® Stellest® lenses showed an average increase in axial length of 0.21 mm compared to 0.45 mm in the single vision group, corresponding to a 53% reduction in axial elongation over two years.
• 75% of eyes in the Essilor® Stellest® group progressed less than 0.50 D over two years, compared to only 36% of eyes in the single vision group.
• Essilor® Stellest® lenses significantly slowed myopia progression across different ages and levels of myopia, with the most pronounced effect in younger children (aged 6-8 years).
• There was no difference in mean high-contrast best-corrected distance visual acuity between groups at the two-year visit, and no serious adverse events were reported.

Overall, the FIN-3101 randomized controlled trial demonstrated that Essilor® Stellest® lenses are safe and effective for children, providing clear clinical benefits.

1. Essilor® Stellest® lenses have received United States FDA market authorization – the first FDA market-authorized spectacle lens indicated for slowing myopia progression in children aged 6 to 12 years at the initiation of treatment, and the first treatment authorized for children aged 6 to 7 years.
2. The FDA decision was supported by two-year clinical trial data from the United States, which showed the lens slowed myopia progression by 71% and axial elongation by 53% on average over two years compared to single vision lenses.
3. Essilor® Stellest® spectacle lenses can now be prescribed for children in the U.S. for myopia management.

Disclaimer: Regulatory status, approved indications, and product availability may vary by country.