May 17, 2021
CHARENTON-LE-PONT, France — The U.S. Food and Drug Administration (FDA) granted Essilor’s Stellest lenses the Breakthrough Device designation. With this FDA recognition, and on the heels of Essilor’s two-year clinical trial for the Stellest lenses, Essilor will be able to pursue further testing and research related to myopia management.
After the first year of Essilor’s clinical trial for the Stellest lenses, the results demonstrated that the eye growth of nine out of 10 children wearing the Essilor Stellest lens was similar or slower than non-myopic children.1
“The Breakthrough Device designation for our Essilor Stellest lens is a great achievement
and an illustration of its potential in slowing down the progression of myopia in children,” said Norbert Gorny, Chief Operating Officer and Chief Research & Development Officer of Essilor International. “This designation represents an important milestone in our fight against the myopia pandemic. We look forward to working closely with the FDA for further clinical study and review so we can provide the benefit of Essilor Stellest to U.S. children who continue to be at risk of vision-threatening complications due to high myopia.”
The Breakthrough Devices Program by the FDA is intended to provide patients and health
care professionals with timely access to medical devices that offer more effective treatment or
diagnosis of life-threatening or irreversibly debilitating diseases or conditions by speeding up
their development, assessment, and review.2
After a successful launch in China and other countries since 2020 with extremely positive
response from eye care professionals, Essilor intends to further roll out Essilor Stellest in
other countries.
References
1 Compared to single vision lenses, when worn at least 12 hours a day. Two-year prospective, controlled, randomized, double-masked clinical trial results – 104 myopic children split in two groups: Single vision lenses (50) and Essilor Stellest lenses (54) – Efficacy results are based on 32 children who declared wearing Essilor Stellest lenses at least 12 hours per day every day – Eye Hospital of the Wenzhou Medical University – J. Bao, A. Yang, Y. Huang, X. Li, Y Pan, C. Ding, E. W. Lim, J Zheng, D. P. Spiegel, Y. L. Wong, B. Drobe, F. Lu, H. Chen.
2 https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program
