FDA Approves Myopia-Slowing Contact Lens for Children
Posted December 6, 2019
The Food and Drug Administration (FDA) has granted premarket approval for the first contact lenses shown to slow the progression of myopia (i.e., nearsightedness) in children aged 8–12. The soft, disposable contact lenses, called MiSight, sharpens distance vision like a typical contact lens. Concentric rings help prevent the eye from elongating and progressively worsening the condition.
Made by CooperVision in San Ramon, CA, the MiSight contact lenses could “slow the progression of myopia in children, which ultimately could mean a reduced risk of developing other eye problems” such as cataracts, glaucoma, and retinal detachment, said Malvina Eydelman, director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices at the FDA Center for Devices and Radiological Health, in a press release.
“We can’t overstate the importance and potential impact of this landmark decision on children’s vision, especially considering the rise in myopia’s severity and prevalence in the U.S. and worldwide,” said Daniel G. McBride, president of CooperVision, in a press release.
The lenses were approved through the FDA’s Premarket Approval (PMA) pathway, which the FDA categorizes as “the most stringent type of device marketing application.” Application approval requires the FDA to conclude that the manufacturer has submitted data that contain “sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use.”
CooperVision’s successful PMA was based on positive results from a three-year safety and effectiveness trail of 144 children aged 8–12 from Canada, Singapore, Portugal, and the U.K., and the FDA’s review of real-world data from a retrospective analysis of 782 medical records. These studies showed that MiSight lenses slowed myopia progression in children by more than 50%, and that the risk of developing corneal ulcers is comparable to adults who wear disposable contact lenses.
As part of the PMA pathway, CooperVision must also conduct a postmarket study of the MiSight lenses to ensure the lenses are safe and effective and work as indicated.
The contact lenses are currently being used in Children Australia, Canada, Spain, and the U.K., with a U.S. launch planned for next year.