Breaking new ground, EssilorLuxottica’s Stellest lens is the first-ever spectacle lens clinically proven to slow myopia progression in children to receive the US Food and Drug Administration’s (FDA’s) market authorisation.
The approval follows the product’s 2021 FDA designation as a Breakthrough Device, acquired through the authority’s De Novo pathway, which provides marketing authorisation for novel, low-to-moderate-risk devices without an existing legally marketed device they can claim to be “substantially equivalent” to.
The efficacy of the Stellest lens is backed by clinical data showing the lens slowed myopia progression by 71% on average, over two years, the company said.
Commenting on the approval, Francesco Milleri, chair and CEO, and Paul du Saillant, deputy CEO of EssilorLuxottica said: “The Essilor Stellest lens has been one of the most highly anticipated vision care products of the last decade. 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.”
Building on its successful international roll-out, the company said it will make Stellest available to the US market in the coming weeks.
