Particle.news
Download on the App Store
4 ARTICLES
·
2w ago

FDA Authorizes Essilor’s Stellest Lens, First U.S. Spectacle Lens Shown to Slow Childhood Myopia

The De Novo authorization follows a U.S. randomized trial reporting a 71% average slowing of pediatric myopia over two years.

A child receives an eye exam at Camerena Health Systems in Madera, California on September 13, 2023.
In the coming weeks, Essilor says, it will make the Stellest lens available for eye-care professionals in the United States who could prescribe them.

Overview

  • The FDA granted De Novo market authorization to EssilorLuxottica’s Stellest spectacle lens, establishing a new device type after a 2021 Breakthrough Device designation.
  • FDA-cited data show a 71% reduction in spherical equivalent refraction and a 53% reduction in eye elongation at 24 months, with no serious adverse events reported.
  • Evidence comes from a prospective, randomized, double-masked, multicenter U.S. clinical trial in children aged 6 to 12 at treatment start.
  • EssilorLuxottica says the lens will be available to U.S. eyecare professionals in the coming weeks following international rollouts.
  • According to the FDA, the lens employs peripheral lenslets that defocus peripheral light to help slow myopia progression, though some users reported blurs and halos.