EssilorLuxottica has announced the US Food and Drug Administration (FDA) has granted market authorisation for its Essilor Stellest lens using the De Novo pathway.
This follows the product’s earlier recognition with the FDA granting designation as a Breakthrough Device in 2021.
The company said the lens was the first FDA market authorised spectacle lens clinically proven to slow myopia progression in children.
It said the effectiveness of the Essilor Stellest lens was evidenced by clinical data showing that the lens slowed down myopia progression by 71% on average over two years.
EssilorLuxottica will make the Essilor Stellest lens available in the coming weeks for US eyecare professionals to equip children following its successful international roll-out.
“The Essilor Stellest lens has been one of the most highly anticipated vision care products of the last decade, said Mr Francesco Milleri, chairman and CEO, and Mr Paul du Saillant, deputy CEO of EssilorLuxottica.
“Facing a global epidemic that impacts millions of lives, we set out years ago to develop a lens that would truly answer the needs of the market, particularly the next generation.
“This lens technology evolves the traditional corrective lenses into a true medical treatment, and it marks the beginning of a new era for eyecare professionals in addressing myopia.”
