FDA Approves Essilor Stellest Lenses to Help Young Children Manage Myopia

The U.S. Food and Drug Administration (FDA) has officially authorized the use of Essilor Stellest eyeglass lenses for children between the ages of 6 and 12 who are diagnosed with myopia, with or without astigmatism. This new approval introduces a promising tool aimed not only at correcting vision but also at slowing the progression of myopia during the critical growth years.

The Essilor Stellest lenses feature a unique design with a central clear zone of 9 mm diameter, surrounded by rings of tiny, raised lenslets. This specialized peripheral ring creates light defocus around the eye, which may help to control the elongation of the eyeball that typically occurs in myopia. Myopia often worsens during childhood when the eyes are still developing, making early intervention essential.

Until now, the primary approved device for managing myopia progression in children aged 8 to 12 was contact lenses. The approval of these lenses offers a new, less invasive alternative for younger children and those who cannot wear contact lenses.

This decision is rooted in a clinical study demonstrating that children using Essilor Stellest lenses experienced a 71% reduction in myopia progression over 24 months, measured by spherical equivalent refraction. Additionally, the study showed a 53% decrease in eye elongation, which is linked to the worsening of myopia. Importantly, no serious adverse effects were reported, although some participants noted experiencing mild visual symptoms like halos and blurriness.

Michelle Tarver, M.D., Ph.D., Director of the FDA Center for Devices and Radiological Health, highlighted that this new lens provides a treatment modality that could significantly decrease the risk of severe visual impairments later in life. It is also easier to use and potentially safer compared to some existing methods.

This development marks a significant step forward in pediatric eye care, offering hope for better management of myopia in children and potentially reducing the burden of later-life visual health issues.