WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration approved the first contact lens developed for slowing the progression of myopia or nearsightedness in children between the ages 8 and 12 years at the initiation of treatment. This could also help in ultimately reducing risk of developing other eye problems.
The regulator granted approval for CooperVision Inc.'s MiSight contact lens, which is a single use, disposable, soft contact lens that is discarded at the end of each day, and not intended to be worn overnight.
The contact lens was approved using the Premarket Approval (PMA) pathway, which is the most stringent type of device marketing application required by FDA.
The approval was based on the data obtained from a prospective clinical trial at four clinical sites and real-world evidence.
The safety and effectiveness of MiSight was studied in a three-year randomized, controlled clinical trial of 135 children in ages between 8 and 12 years at the start of treatment who used MiSight or a conventional soft contact lens.
The trial results showed that the progression in myopia of those wearing MiSight contact lenses was less than those wearing conventional soft contact lenses over a full three-year period.
Over three years, children wearing MiSight had 59 percent less myopia progression and 52 percent less axial elongation on average than those wearing a single-vision one-day lens.
Further, children who used MiSight also had less change in the axial length of the eyeball at each annual checkup.
Additionally, the FDA reviewed real world data from a retrospective analysis of medical records of 782 children ages 8 to 12 years from seven community eye care clinics.
Myopia is the most frequent cause of correctable visual impairment, which is common in children and tends to increase as they get older. It occurs when the axial length of the eye grows too long from front to back, which leads to images being focused at a point in front of the retina, instead of focusing images on the retina.
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