The FDA gives a green light to MiSight, a single use, contact lens to slow the progression of nearsightedness in children.
The US Food and Drug Administration (FDA) is approving the MiSight contact lens, a single use, disposable, soft contact lens that slows the progression of myopia in children between 8-12.
The new daily worn lenses correct nearsightedness and slow the progression of myopia in children with healthy eyes.
When the lens is placed on the eye, 1 part of the lens corrects the refractive error to improve distance vision. The concentric peripheral rings in the lens focus part of the light in front of the retina to reduce the stimulus causing the progression of myopia.
"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 Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices in the FDA's Center for Devices and Radiological Health, said in a statement.
The approval is based on a prospective clinical trial at 4 sites and a 3-year randomized, controlled clinical trial of 135 children from 8-12. The trial showed that the progression of myopia was less for those wearing the MiSight lenses than those wearing conventional soft contact lenses.
Also, subjects who used MiSight had less change in the axial length of the eyeball at each annual checkup.
There were no serious ocular adverse events in either arm of the study.
Additionally, to estimate the rate of vision-threatening corneal infections (among children and adolescents who wear soft contact lenses daily, the FDA reviewed real world data from a retrospective analysis of medical records of 782 children ages 8-12 years old from 7 community eye care clinics. The results showed a rate comparable to the rate of ulcer cases among adults who wear contact lenses daily.
Myopia, the most frequent cause of correctable visual impairment across the globe, occurs when the eye grows too long from front to back. Rather than focusing images on the retina, images are focused at a point in front of the retina.