05.17.21

Essilor Receives FDA Breakthrough Device Designation for Essilor Stellest Spectacle Lens

Source: Essilor

Essilor announced that the FDA has granted Breakthrough Device designation to its Essilor Stellest spectacle lens, the company’s new generation lens developed to correct myopia and slow down the progression of myopia in children.

The designation of the Essilor’s Stellest spectacle lens as a “Breakthrough Device” by the FDA will lead to further U.S. research and FDA review, and builds on the publication of 2-year results of an ongoing 3-year clinical trial in China in myopic children. After the first year, the trial results demonstrated that the eye growth of 9 out of 10 children wearing the Essilor Stellest lens was similar or slower than non-myopic children.1 While after 2 years, Essilor Stellest lens has been proven to be among the most effective myopia control solutions which have ever been tested.

“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. This designation represents an important milestone in our fight against the myopia pandemic,” Norbert Gorny, Chief Operating Officer and Chief Research & Development Officer of Essilor International, said in a company news release. “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


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.


https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program.

 

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