California company gets FDA nod for first contact lens to slow nearsightedness in kids
Parents of children who are nearsighted will soon have another option for helping deal with the condition. The U.S. Food and Drug Administration has approved the first contact lens to curb myopia in kids between the ages of 8 and 12 years old.
The FDA gave the go ahead to Cooper Vision, a division of medical device maker Cooper Companies, to bring to market its MiSight contact lens, a single use, disposable soft contact lens intended to be thrown out at the end of the day. The company said it would start selling the product in the U.S. starting in March of next year.
Cooper shares rose 1.5% on Monday, while the overall stock market trended lower. Based in Pleasanton, Calif., the company provides a range of health care products and services, including medical devices, genetic diagnosis, IVF screening and more.
Common in children, myopia tends to get worse as they get older, according to the FDA. The condition, in which people can see close objects clearly while things further away are blurry, affects nearly 30% of the U.S. population, according to the American Optometric Association.
Laser procedures can sometimes be used to treat myopia in adults, but the options are more limited in childhood, which is typically when nearsightedness develops. Children can wear eyeglasses or contact lenses to correct blurred vision, but neither are intended to slow the progression of myopia in kids.
The MiSight lens yielded positive results in a multi-year study of 144 myopic children in the U.S. and four other countries, CooperVision said in an announcement.
MiSight 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," said Malvina Eydelman, M.D., 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 announcing the agency's move to approve the contact lens.
A three-year clinical trial found that children who wore the MiSight lenses saw their myopia progress more slowly than those who wore conventional soft contact lenses, according to the FDA.
Daniel McBride, president of Cooper Vision, said that "Eye care professionals who embrace this breakthrough approach will improve the quality of life and eye health for so many children."
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