09/26/2025
The FDA has granted De Novo market authorization for the Essilor Stellest lens, making it the first spectacle lens in the United States clinically proven to slow myopia progression in children. This decision follows its earlier designation as a Breakthrough Device and represents a milestone in expanding evidence-based myopia management options for U.S. eyecare professionals.
In a prospective, multicenter, double-masked study of children ages 6–12, Stellest demonstrated a 71% average reduction in myopia progression compared to single vision lenses over two years. The trial also confirmed significant slowing of axial elongation, establishing Stellest as a validated non-pharmacologic intervention in early childhood.
Six-year longitudinal data (China, COOC 2025)
Longer-term findings presented at the China Optometry & Ophthalmology Conference extend the evidence base:
-Myopia progression slowed by 1.95 D (57%) over six years.
-Axial elongation reduced by 0.81 mm (52%).
-Risk of progressing to high myopia (-6.00 D or worse) decreased from 38% in the extrapolated single vision control group to 9% in the Stellest group.
-Benefits were sustained through ages 14–19, supporting the lens’ effectiveness beyond childhood into adolescence.
Clinical implications
These findings are highly relevant given current epidemiology. In North America, one in four children ages 6–19 is myopic, and the global prevalence is projected to reach one in two people by 2050. Slowing axial elongation is central to reducing lifetime risks of retinal detachment, myopic maculopathy, glaucoma, and other sequelae. The six-year data demonstrate that sustained myopia control is achievable with Stellest lenses, providing an important addition to the current toolkit alongside lifestyle counseling, contact lens–based interventions, and low-dose atropine.
At ReFocus Eye Health, with more than 150 providers across 75+ locations in eight states, we view this FDA authorization as a welcome addition for our clincians ability to integrate evidence-based strategies early, with the goal of protecting long-term visual outcomes in children and adolescents.
