The San Ramon, Calif.–based company announced the clearance for the first and only FDA-approved product clinically proven to slow myopia (nearsightedness or short-sightedness) yesterday. CooperVision said traditional eyeglasses and contact lenses in the U.S. were only developed to correct blurred vision but not to slow myopia’s progression.
CooperVision highlighted results from a 144-person study across Singapore, Canada, Portugal and the U.K. which showed that MiSight slowed myopia progression at a 59% rate when measured by mean cycloplegic spherical equivalent and 52% when measured by mean axial elongation of the eye.
The trial is ongoing and encouraging results from years four and five included older children who are wearing the MiSight lens into their late teens, according to a news release.
CooperVision plans to launch MiSight as part of a myopia management initiative in the U.S., beginning in March 2020. The lens is already worn by myopic children in Canada, Spain, Australia and the U.K., according to the release. In addition to those four countries, MiSight is approved for sale in a number of countries across Europe and Asia.
“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 the release. “Eye care professionals who embrace this breakthrough approach will improve the quality of life and eye health for so many children.”
“[The] 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,” director of the FDA’s Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Services Dr. Malvina Eydelman said in a separate release.
“CooperVision is more committed than ever to eye health innovation,” added CooperVision EVP of Americas & global commercial functions Jerry Warner. “The time and effort we put into receiving FDA approval was well-spent. We’re bringing a game-changing myopia management approach to U.S. eye care professionals that will benefit countless kids throughout the country.”