Essilor’s Stellest lens – released into the Australian and New Zealand market in 2022 – has just been approved by the United States Food and Drug Administration (FDA), making it the first-ever FDA approved spectacle lens for myopia in the US.
EssilorLuxottica has announced the FDA market authorisation for its Essilor Stellest lens using the De Novo pathway, a regulatory pathway for novel medical devices that are low to moderate risk and do not have a legally marketed predicate device for comparison.
This follows the product’s earlier recognition with the FDA granting designation as a Breakthrough Device in 2021.
The effectiveness of the Essilor Stellest lens is evidenced by clinical data showing that the lens slowed down myopia progression by 71% on average over two years
Prior to Essilor Stellest eyeglass lenses, the only US FDA approved device for slowing the progression of myopia was contact lenses for 8- to 12-year-olds. The Essilor Stellest eyeglass lenses provide an option for children aged 6- to 7-years old and for children who are unable to wear contact lenses.
EssilorLuxottica said the Stellest lens is the first-ever FDA market authorised spectacle lens clinically proven to slow myopia progression in children.1
The effectiveness of the Essilor Stellest lens is evidenced by clinical data showing that the lens slowed down myopia progression by 71% on average over two years.2
The lens will be available in the coming weeks for US eye care professionals.
“The Essilor Stellest lens has been one of the most highly anticipated vision care products of the last decade,” said Francesco Milleri, Chairman and CEO, and Paul du Saillant, Deputy CEO of EssilorLuxottica in a news release.
“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 eye care professionals in addressing myopia,” the statement read.
References
- EssilorLuxottica, Essilor Stellest is the first and only FDA market authorized spectacle lens in the United States (news release, 25 Sept 2025).
- United States Food and Drug Administration, FDA authorizes marketing of first eyeglass lenses to slow progression of pediatric myopia. (news release, 25 Sept 2025). Available at: fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-eyeglass-lenses-slow-progression-pediatric-myopia (accessed Sept 2025).
