Essilor 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.
What does “Breakthrough Device” Designation Mean?
The designation of the Essilor’s Stellest spectacle lens as a “Breakthrough Device” by the FDA, that will lead to further U.S. research and FDA review, builds on the publication of two-year results of an ongoing three-year clinical trial, in China.
Breakthrough Device designation allows companies to benefit from additional FDA input as they work to validate the safety and efficacy of their devices during pre-market development and during the submission process. The status is voluntarily applied for by the company.
Once filed, the review may be expedited. The designation does not allow the device to be marketing (in the US). Marketing activities still require approval or conditional approval before doing so.
“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 U.S. children who continue to be at risk of vision-threatening complications due to high myopia.” commented Norbert Gorny, Chief Operating Officer and Chief Research & Development Officer of Essilor International.
Clinical Study Update & Global Rollout
After the first year, the trial results reported by the company demonstrated that the eye growth of 9 out of 10 children wearing the Essilor Stellest lens was similar or slower than non-myopic children.
According to the company, the lens has been successfully launched in China followed by other countries since 2020. Essilor intends to further roll out Stellest in other countries.
Launch date for Canada was unavailable at publication date.
Click HERE for the full press release.
