The U.S. Food and Drug Administration (FDA) announced on September 29, 2025, the authorization of Essilor Stellest eyeglass lenses. This groundbreaking approval provides a new option for managing myopia progression in children aged six to twelve years. Myopia, commonly known as nearsightedness, is a growing concern globally, particularly among pediatric populations. The newly approved lenses aim to curb this trend with safe, effective technology.
What changed?
The FDA’s authorization of Essilor Stellest eyeglass lenses represents a significant leap in managing myopia among children. Myopia is a chronic condition affecting nearly 40% of the U.S. population. Previous options for slowing its progression were limited to contact lenses approved for use in children aged eight to twelve. The Essilor Stellest lenses expand this age range to include six-year-olds and cater to those unable to use contact lenses. Importantly, these glasses pose a lower risk of adverse events like infections compared to contact lenses.
Clinical findings supporting the approval
The FDA’s authorization followed an evaluation of two years of clinical study data. The study compared the Essilor Stellest lenses with single vision control lenses, analyzing changes in spherical equivalent refraction and axial length—key indicators of myopia progression.
- At 24 months, results showed a 71% reduction in myopia progression based on spherical equivalent refraction measurements.
- The study also demonstrated a 53% reduction in eye elongation, linked to axial length calculations.
No serious adverse events were reported during the trials, although some participants noted visual symptoms like blur and halos. There are no contraindications labeled for this device, ensuring broad accessibility.
Who is affected?
The Essilor Stellest eyeglass lenses are intended for children aged six to twelve at the initiation of treatment. This device addresses a critical gap in managing early-onset myopia, potentially curbing severe eyesight issues later in adult life. By slowing progression while children’s eyes are still developing, these lenses can significantly reduce risks associated with high myopia, such as retinal detachment, glaucoma, and cataracts.
Parents of young children showing early signs of myopia, ophthalmologists, optometrists, and regulatory professionals should note this vital development.
Frequently Asked Questions
- What makes Essilor Stellest eyeglass lenses different from other devices for myopia management?
These lenses use peripheral lenslets to provide peripheral light defocus, which slows myopia progression. Unlike contact lenses, they are lower risk and suitable for younger children. - Are there any side effects associated with these lenses?
Clinical studies reported occasional visual symptoms such as blur and halos, but no serious adverse events were noted. - How long does treatment with Essilor Stellest lenses typically last?
Myopia management is most effective during childhood as the eyes grow and stabilize by early adulthood.
Conclusion
The FDA’s clearance of Essilor Stellest eyeglass lenses offers a new, safer, and accessible option for managing pediatric myopia progression. With solid clinical evidence supporting its efficacy, this innovative device addresses a critical unmet need in myopia treatment for children. Parents and eye care professionals should explore this opportunity to proactively reduce risks of severe vision complications later in life.
Disclaimer
This article is intended for informational purposes only and does not constitute legal, medical, or regulatory advice. Always consult relevant professionals for guidance specific to your circumstances.
FDA announcement link
For full information about the FDA announcement, see the link below.