US FDA authorizes marketing of Essilor Stellest eyeglass lenses for the correction of myopia

The US Food and Drug Administration (FDA) has now authorized marketing of the Essilor Stellest eyeglass lenses for the correction of myopia with or without astigmatism.¹ The lens works to slow the progression of myopia in children aged 6-12 at the initiation of treatment, according to an FDA news release.

The FDA had previously granted breakthrough device designation for the lenses on April 30, 2021, which allowed for the expedition of the development and review of the lens. Now, the lens was granted marketing authorization through the De Novo premarket review pathway to Essilor of America Inc.¹

“As a practicing ophthalmologist, I see firsthand the lifelong impact that vision problems can have on an individual. Today’s authorization brings to market a treatment option that may meaningfully reduce the likelihood of severe eyesight issues later in adult life, while also being easier to use and lower risk than the currently authorized devices that slow the progression of myopia in children,” said Center for Devices and Radiological Health Director Michelle Tarver, MD, PhD, in the release.

Prior to the authorization of Essilor Stellest lenses, there was only one approved device for slowing the progression of myopia, which are contact lenses for 8-12 year olds. Thus, the Essilor Stellest lenses are able to combat myopia progression earlier in children 6-7 years old and children who are unable to wear contacts. According to the FDA, the Essilor Stellest lenses are a lower risk device compared to contact lenses and do not have adverse events that could be associated to the use of contact lenses, including infections.¹

The Stellest lenses have a clear 9mm diameter area in the center, which is surrounded by peripheral lenslets, or rings of tiny raised dots, on the remainder to the lens. These dots provide peripheral light defocus, which has been found to potential slow the progression of myopia in children.¹

Prior to the authorization, the FDA evaluated 2 years of data from a clinical study that demonstrated that the Stellest lenses slowed myopia progression when compared to single vision control lenses. This study measured the change of glasses prescription (spherical equivalent refraction) and the change in the length of the eye (axial length). The study demonstrated a 71% reduction in myopia progression for spherical equivalent refraction and a 53% reduction in eye elongation, both at 24 months. While no serious adverse events were reported in the study, some participants did experience visual symptoms, such as blur and halos, while wearing the Stellest lenses. There are no labeled contraindications.¹

According to Essilor, 67% of myopia progression slowdown on average was reported, compared to single vision lenses, when worn 12 hours a day. Additionally, 100% of children were reported to have fully adapted to Stellest lenses within a week of wear. The lenses are also available in sun tints, which protects its wearers from UV and glare.²

Additionally, the FDA’s review of the Stellest lenses through the De Novo premarket review pathway is designated for low- to moderate-risk devices of a new type. The FDA is establishing special controls that define the requirements related to labeling and performance testing. When these requirements are met, the special and general controls will provide a reasonable assurance of safety and effectiveness for the device type.¹

References:

1. FDA authorizes marketing of first eyeglass lenses to slow progression of pediatric myopia. News release. US Food and Drug Administration. September 25, 2025. Accessed September 26, 2025. https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-eyeglass-lenses-slow-progression-pediatric-myopia?utm_medium=email&utm_source=govdelivery

2. Stellest. Essilor. Accessed September 26, 2025. https://www.essilor.com/ca-en/products/stellest/