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October 28, 2020 04:00pm
By Sara Karlovitch, Assistant Editor
Officials from the FDA have approved MiSight 1-day contact lenses (CooperVision), a daily wear, single use contact lens indicated for the use of myopia management. This is the first and only FDA-approved product clinically proven to slow the progression of myopia, or near-sightedness, when initially prescribed for children 8-12 years old.
Officials from the FDA have approved MiSight 1-day contact lenses (CooperVision), a daily wear, single use contact lens indicated for the use of myopia management. This is the first FDA-approved product clinically proven to slow the progression of myopia, or near-sightedness, when initially prescribed for children ages 8-12 years, according to CooperVision.
Myopia causes light rays to focus at a point in front of the retina rather than directly on the surface due to the elongation of the eye. The progression of myopia has been linked to sight-threatening conditions later in life, such as cataracts, retinal detachment, and glaucoma.
Traditional eyeglasses and contact lenses in the United States have only been developed to correct blurred vision, while not approved to slow the progression of myopia.
The approval is supported from the results of a multicenter, randomized study taking place in Singapore, Canada, the United Kingdom, and Portugal. One hundred-forty four children, ages 8-12 years, with myopia were analyzed over 3 years, which helped the FDA approve an age range for the initial fitting. MiSight 1-day was shown to slow myopia progression overall in the study, with 59% as measured by mean cycloplegic spherical equivalent (SE) and 52% as measured by mean axial elongation of the eye.
In years 4 and 5 of the study, high results have been reported with older children who have begun to wear the contact lenses in their late teens. Myopia usually first occurs in school-age children and progresses until around the age of 20 years. A study from August 2018 showed that 41.9% of US children aged 5-19 years are myopic. Factors of developing myopia include children spending less outdoor time and more time spent focusing on close objects, such as digital screens.
Breakthrough CooperVision MiSight 1 Day Contact Lens for childhood myopia coming to the United States in 2020 [news release]. San Ramon, CA; CooperVision: November 18, 2019. https://coopervision.com/our-company/news-center/press-release/misight-1-day-fda-approval. Accessed November 19, 2019.