November 19, 2019
The first contact lens designed to slow down the progression of nearsightedness in children will hit the market in March.
The U.S. Food and Drug Administration recently approved the MiSight contact lens, created by CooperVision, for use in children between the ages of 8 and 12 years old.
Nearsightedness, also known as myopia, is a condition in which people have difficulty seeing things at a distance – such as a whiteboard at school or a movie screen at the theater. People with myopia can see objects clearly when they are up close, but objects appear blurry when they are farther away.
Research has shown that worsening nearsightedness may increase the risk of cataracts, retinal detachment and glaucoma.
The American Optometric Association reports that nearsightedness affects about 30% of Americans. While there is no exact cause, there is a genetic predisposition for it when one or more of your parents are nearsighted. It typically develops first in childhood and progresses into early adulthood, until about the age of 20.
"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," Dr. Malvina Eydelman, 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 MiSight contact lens are disposable and indicated for single use only. The lenses are not meant to be slept in. Children should put a new set in their eyes each morning.
According to the FDA, "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 (the back of the eye). This is believed to redirect the stimulus causing the progression of myopia."
FDA approval was based on data from a clinical trial at four sites and real world analysis. The clinical trial, conducted over three years, included 135 children who between the ages of 8 and 12 who started treatment with MiSight or standard soft contact lenses. The children wearing MiSight lenses had less myopia progression over the three years than those wearing the standard soft contact lenses, researchers found.
To investigate potential side effects, the FDA also conducted a retrospective analysis of the medical records of 782 children from seven different eye care clinics. They found that the rate of ulcer development was similar to that of adults who wear contact lenses every day.
"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," CooperVision President Daniel G. McBride said in a statement. "Eye care professionals who embrace this breakthrough approach will improve the quality of life and eye health for so many children."
As part of the FDA approval process, CooperVision will be expected to conduct a post-market study to continue to evaluate the MiSight lenses' safety and effectiveness.