Essilor Stellest lens granted FDA breakthrough device designation
The designation of the lens, developed to correct myopia and slow its progression in children, will lead to further research and FDA review
18 May 2021
Essilor has been granted a breakthrough device designation from the US Food and Drug Administration (FDA) for the Essilor Stellest lens.
The lens has been developed to correct and slow down the progression of myopia in children.
The FDA Breakthrough Devices Program works to accelerate the development, assessment and review of medical devices that offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The designation of the Essilor Stellest lens will lead to further research and FDA review.
Norbert Gorny, chief operating officer and chief research and development officer of Essilor International, called the designation an “important milestone” for the company’s work against myopia, suggesting it illustrated the potential of the Essilor Stellest lens in slowing down the progression of myopia in children.
“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 US children who continue to be at risk of vision-threatening complications due to high myopia,” he said.
Essilor launched the lens in the Wenzhou Medical University Eye Hospital in China in July 2020, with roll-out continuing to other countries including a launch planned in France from 1 June.
The company confirmed to OT that the Essilor Stellest product is compliant to EU regulation on medical devices 2017/745, and is already registered for market release in the EU single market. The company added that there is no schedule yet for roll-out in the UK.
Earlier this year, the company published two-year results of an ongoing three-year clinical trial in children with myopia in China. The recent trial results indicated that after two years of wearing the lenses for 12 hours or more each day, the progression of myopia slowed by 67% on average, compared with children wearing single vision lenses.