Dive Brief:
- The Food and Drug Administration has authorized a spectacle lens from EssilorLuxottica for use in children with nearsightedness.
- EssilorLuxottica, which announced the de novo authorization on Thursday, linked the lenses to a 71% reduction in the progression of nearsightedness in a 24-month study.
- CooperVision already sells contact lenses in the U.S. to manage nearsightedness. The FDA said EssilorLuxottica’s eyeglass lens is a lower-risk device that is suitable for use in younger children.
Dive Insight:
Myopia, the medical term for nearsightedness, affects around 40% of the U.S. population and prevalence is increasing rapidly among children and adolescents, the FDA said. When the chronic disease progresses to high myopia, people are at greater risk of sight-threatening complications such as retinal detachment, myopic maculopathy, glaucoma and cataracts later in life.
The Essilor Stellest eyeglass lenses are designed to slow myopia progression in children. The lenses have a clear 9mm diameter area in the center. Rings of tiny raised dots surround the clear center to defocus peripheral light. Studies suggest blurring side vision may slow eye growth and limit myopia.
EssilorLuxottica tested the lenses in a randomized multicenter U.S. clinical trial in myopic children aged 6 to 12 years. After two years, investigators saw a 71% reduction in myopia progression in children using the lenses. The slowdown in myopia progression was accompanied by a 53% reduction in eye elongation, a cause of nearsightedness.
Based on the data, the FDA authorized the lens to correct myopia with or without astigmatism and to slow disease progression in children 6 to 12 years old at the start of treatment. EssilorLuxottica plans to make the lens available in the U.S. in the coming weeks.
The device is the first eyeglass lens authorized to slow the progression of myopia in children in the U.S., but the market is already served by a contact lens product. CooperVision received FDA approval for its MiSight 1 Day lenses in 2019.
EssilorLuxottica’s label supports use in children as young as 6 years old, compared with 8 years old for the contact lens. The FDA said the eyeglass lens also extends treatment to children who are unable to wear contacts and is a lower-risk device. Contact lenses are associated with adverse events such as infections that are not linked to the use of eyeglasses.
The FDA has created special controls as part of the de novo authorization of EssilorLuxottica’s lens. The special controls define the labeling and performance testing requirements that companies need to meet to bring similar devices to market.
