CooperVision has received U.S. Food and Drug Administration (FDA) approval of its MiSight 1 day contact lens. This daily wear, single use contact lens is the first and only FDA-approved product clinically proven to slow the progression of myopia (nearsightedness or short-sightedness) when initially prescribed for children 8 to 12 years old.
“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,” says Daniel G. McBride, president of CooperVision. “Eyecare professionals who embrace this breakthrough approach will improve the quality of life and eye health for so many children.”
The MiSight contact lens is discarded at the end of each day and is not intended to be worn overnight. MiSight 1 day will launch in the U.S. as part of a CooperVision myopia management initiative, beginning in March 2020. According to the company, the lens is already being successfully worn by myopic children in other parts of the world, including Canada, the United Kingdom, Spain, and Australia.
The approval of MiSight was based on data obtained from a prospective clinical trial at four clinical sites and real-world evidence. As part of the clearance of MiSight, CooperVision is required to conduct a post-market study of the lenses to further evaluate the safety and effectiveness of the product as indicated.
“While there is growing acknowledgement and interest in stemming myopia’s progression, there needs to be more urgency to act earlier,” says Michele Andrews, O.D., senior director of North America Professional and Academic Affairs for CooperVision, and a thought leader in the company’s recent #ProtectKidsVision myopia panel (pictured, L-R: Melissa Musen Gerstein, co-founder of multimedia company, The Moms; Jen Trachtenberg, O.D.; Donna Mazyck, executive director of the National Association of School Nurses; and Dr. Andrews). “We believe that MiSight 1 day will be a catalyst that helps ECPs move faster and gives rise to better ECP-parent conversations about the issue. It’s a privilege to be at the forefront of myopia management. Working alongside so many dedicated ey care professionals and passionate parents, we’re already making a meaningful difference in tackling myopia, and can now expand our efforts into the U.S.”
To learn more about CooperVision's new myopia management initiative, head to its new website: coopervision.com/practitioner/myopia-management.