The FDA has approved its first contact lens designed to effectively slow the progression of nearsightedness in children, starting in ages 8 to 12.
CooperVision’s MiSight lens is a soft, single-use and disposable contact, made to be discarded at the end of each day.
A three-year clinical study showed the lens was able to slow the elongation of the eyeball from front to back by an average of 52% across annual check-ups—one of the main causes of myopia, as incoming images begin to come into focus at a point in front of the retina, instead of precisely on it.
“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 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.”
The MiSight lens could also ultimately reduce children’s risks of developing other eye problems, according to Malvina Eydelman, director of the FDA office tasked with evaluating ophthalmic devices. Children who develop severe myopia are more likely to be susceptible to cataracts or a detached retina during adulthood.
The three-year clinical trial, which enrolled 135 children, also demonstrated 59% slower myopia progression through the optics measurement of average cycloplegic spherical equivalent, compared to a control group of children wearing conventional, one-day soft contact lenses. CooperVision reported that it received encouraging study results through years four and five, and that some participants are still wearing the lens into their late teens.
When placed on the eye, part of the lens works to improve distance vision by correcting the refractive error similar to a standard contact. The MiSight lens also features concentric rings placed around the periphery, which split off light and focus it in front of the retina, to help reduce the stimulus believed to drive the progression of nearsightedness.
CooperVision plans to launch the lens in the U.S. starting in March 2020. It is already available in Canada, the U.K., Spain and Australia, for children of varying ages.