November 18, 2019
The US Food and Drug Administration (FDA) has approved the first contact lens indicated to slow myopia progression in children aged 8 to 12 years.
Myopia is common in children and tends to increase as they age. Children who develop severe myopia may be susceptible to other eye problems, such as early cataracts or a detached retina during adulthood.
Slowing the progression of myopia in children "ultimately could mean a reduced risk of developing other eye problems," Malvina Eydelman, MD, director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices in the FDA's Center for Devices and Radiological Health, said in a news release.
When placed on the eye, one part of the MiSight contact lens corrects the refractive error to improve distance vision in nearsighted eyes, similar to a standard corrective lens. In addition, concentric peripheral rings in the lens focus part of the light in front of the retina, which is thought to reduce the stimulus causing the progression of myopia, the FDA explains in the release.
The safety and effectiveness of MiSight contact lenses were demonstrated in a clinical trial involving 135 children aged 8 to 12 years at the start of treatment who used MiSight or a conventional soft contact lens.
Over 3 years, the progression in myopia in children wearing MiSight lenses was less than in their peers wearing conventional soft contact lenses. In addition, at each annual checkup, children who used MiSight were found to have experienced less change in the axial length of the eyeball. During the course of the trial, there were no serious ocular adverse events in either arm of the study.
The FDA also reviewed real-world data from a retrospective analysis of 782 children aged 8 to 12 who wear soft contact lenses to estimate the rate of vision-threatening corneal infections, according to the FDA release. The results showed that the rate of corneal ulcers in children was comparable to that in adults who wear daily contact lenses.
The FDA will require CooperVision to conduct a postmarket study of MiSight contact lenses to further evaluate safety and effectiveness.
MiSight contact lenses were approved using the premarket approval (PMA) pathway, which is the most stringent type of device marketing application required by the FDA and is based on a determination by the FDA that the PMA application contains "sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use(s)."