At press time, the FDA approved the MiSight 1 day contact lens (CooperVision) to slow myopia progression in those ages 8 to 12.
“... We [CooperVision] are learning from other countries in which MiSight is already prescribed to enable the best possible outcomes for the [U.S.] ECP,” says Michelle Andrews, O.D., the company’s senior director, North America Professional and Academic Affairs.
One part of the of the daily wear, single-use lens corrects refractive error to improve distance vision. In addition, concentric peripheral rings in the lens focus part of the light in front of the retina.
BASIS FOR APPROVAL
FDA approval was based on the results of a prospective three-year randomized, controlled clinical trial at four sites and real-world evidence, the government agency says.
To start, the results of the clinical trial, comprised of 135 children ages 8 to 12, showed patients who wore the MiSight lens vs. a conventional soft lens had less myopia progression and axial length change for the full three years. Also, no serious ocular adverse events were reported in either group. (See https://bit.ly/37mfdTM .)
In regard to real-world evidence, the FDA found the rate of corneal ulcers in contact lens-wearing children was comparable to those of adult wearers.
The MiSight lens’ U.S. launch is March 2020, as part of a CooperVision myopia management initiative, the company says. Visit https://bit.ly/2NYYb6G . OM