Essilor’s Stellest receives FDA Breakthrough Device status
Author: Andrew McClean
Essilor has received Breakthrough Device status from the US Food and Drug Administration (FDA) for its Stellest spectacle lens that was developed to correct and slow myopia progression.
The FDA designation of the spectacle lens led to further FDA research and review that built on Essilor’s ongoing three-year clinical trial.
Norbert Gorny, COO and chief research and development officer at Essilor International, said: ‘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.
‘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.’
The FDA’s Breakthrough Device programme was designed to provide patients and healthcare professionals with timely access to medical devices by speeding up their development, assessment and review.
Essilor added that after Stellest’s launch in China and other countries since 2020, it intended to further roll out the spectacle lenses.