• By Kanaga Rajan
    FDA, CooperVision
    Pediatric Ophth/Strabismus

    A contact lens for slowing pediatric myopia progression has received the FDA’s approval, according to manufacturer CooperVision. The MiSight is a daily wear, single-use lens indicated for children aged 8 to 12 years old.

    Similar to standard corrective lenses, the MiSight improves nearsighted eyes by correcting refractive error. The addition of concentric peripheral rings, however, enable the lens to focus part of the light in front of the retina—mitigating the stimulus for progressive myopia. The soft disposable lenses are discarded at the end of each day and are not worn overnight.

    “Today’s approval is the first FDA-approved product to slow the progression of myopia in children, which ultimately could mean a reduced risk of developing other eye problems,” Malvina Eydelman, MD, director of the FDA’s office of ophthalmic, anesthesia, respiratory, ENT and dental devices, said in a statement.

    The clearance comes on the heels of a 3-year, randomized, controlled prospective trial comprising 135 children. Children wearing the MiSight experienced less progression of myopia and axial lengthening than those randomized to conventional soft contact lenses, which was documented during annual visits. There were no serious ocular adverse events. Real-world data from 782 children showed that the rate of corneal ulcer cases with MiSight was comparable to adults wearing daily lenses.

    As a condition of the approval, CooperVision will conduct a postmarket study to further confirm safety and effectiveness.

    “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,” stated the company’s president, Daniel G. McBride. “Eye care professionals who embrace this breakthrough approach will improve the quality of life and eye health for so many children.”

    The MiSight 1-day lens is expected to launch in the United States in early 2020. The product is already available in other countries such as Canada, the United Kingdom, Spain and Australia.