EssilorLuxottica has received FDA authorization to market the Essilor Stellest eyeglass lenses for the correction of myopia and to slow myopia progression in children 6-12 years of age at the initiation of treatment.
This marks the authorization of the first eyeglass lenses to slow the progression of pediatric myopia.
Exciting stuff! Tell me about these lenses.
Originally designated as a Breakthrough Device in 2021, the Essilor Stellest lenses utilize the Highly Aspherical Lenslet Target (HALT) technology and feature a clear 9 mm central zone surrounded by rings of aspherical lenslets, which provide peripheral light defocus.
This authorization was granted using the De Novo pathway for novel medical devices.
Wait—didn’t Essilor have another myopia lens in the pipeline?
You’re thinking of SightGlass Vision’s DOT (Diffusion Optics Technology) spectacle lenses—developed by SightGlass Vision, a joint venture of CooperCompanies and EssilorLuxottica.
DOT lenses use thousands of micro-“dots” that subtly reduce retinal contrast to slow eye growth—a different optical strategy from Stellest’s peripheral lenslet defocus. They are not commercially available in the United States.
Got it. Tell me about the evidence backing the Stellest lenses.
In a randomized, double-masked trial, Stellest demonstrated a 71% reduction in myopia progression (measured in spherical equivalent refraction) and a 53% reduction in axial elongation compared with single-vision control lenses at 24 months.
And the target patient base?
Children 6-12 years old at the initiation of treatment.
Prior to these eyeglass lenses, there was only one approved device for slowing the progression of myopia in children ages 8-12—the MiSight 1-Day contact lenses for myopia control.
“The Essilor Stellest eyeglass lenses can fill the gap for children 6 to 7 years old or for children who are unable to wear contacts,” noted the FDA. “These Essilor Stellest eyeglass lenses are a lower risk device compared to contact lenses and do not have adverse events (such as infections) that may be associated with the use of contact lenses.”
Any warnings or contraindications to know about?
There are no contraindications for the Stellest eyeglass lenses and no serious adverse events reported in the study.
Some patients did note blur and halos as well as similar visual symptoms.
So what’s the big-picture significance of this approval?
This is the first spectacle lens in the U.S. authorized to slow pediatric myopia progression, an important public health milestone given the rising global prevalence of myopia and the risks associated with higher degrees of the condition.
“Higher levels of myopia are frequently associated with severe eye pathologies later in life, hence the need to provide families with solutions not only to correct myopia but also slow its progression, thanks to dedicated spectacle lenses for example,” noted EssilorLuxottica.
And finally—what’s next and how can I get these lenses for my practice?
No exact information on when the U.S. rollout will start was shared, but stay tuned for word from Essilor on when these lenses will be available to eyecare professionals!