May 20, 2021 — Essilor recently announced that the U.S. Food and Drug Administration (FDA) has granted “Breakthrough Device” designation to its Essilor Stellest spectacle lens, the company’s new lens developed to correct myopia and slow down the progression of myopia in children.

Essilor has shared that the “Breakthrough Device” designation will lead to further U.S. research and FDA review. The designation builds on the publication of two-year results of an ongoing three-year clinical trial in China on 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.

“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,” says 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 FDA’s Breakthrough Devices Program is designed 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.

Learn more about the Essilor Stellest lens at essilor.com.