SAN RAMON, Calif.—CooperVision announced today that its innovative MiSight 1 day contact lens will launch in the U.S. early next year as part of a CooperVision myopia management initiative. The initiative is scheduled to begin in March. The MiSight lens received Food and Drug Administration (FDA) approval on Friday (Nov. 15), as VMAIL reported, and will be the cornerstone of a comprehensive myopia management approach to be offered by CooperVision, according to the company’s announcement.

As part of the initiative, CooperVision also has launched a dedicated web page for practitioners to learn more about myopia management. The site is accessible here. 

The daily wear, single-use MiSight 1 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 8-12 years old,” according to CooperVision.

The lens is already being successfully worn by thousands of myopic children in other parts of the world, including Canada, the United Kingdom, Spain and Australia, where age ranges for initial fitting may vary. It has been recognized as one of the most innovative developments in eye health by the likes of the British Contact Lens Association and international industry media, according to CooperVision.

“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 G. McBride said in the announcement. “Eyecare professionals who embrace this breakthrough approach will improve the quality of life and eye health for so many children.”

Myopia causes light rays to focus at a point in front of the retina rather than directly on the surface, due to elongation of the eye. Myopic progression has been linked to sight-threatening conditions later in life such as cataracts, retinal detachment, glaucoma and myopic maculopathy. Even children with fairly mild prescriptions have a higher risk of glaucoma and retinal detachment later in life, compared to their non-myopic peers, and the risk multiplies as their prescriptions get stronger, CooperVision said in its announcement. This is echoed in a seminal 2015 report on the issue from the World Health Organization (WHO), which declared that “myopia and high myopia are increasing globally at an alarming rate, with significant increases in the risks for vision impairment from pathologic conditions associated with high myopia.”

“CooperVision is more committed than ever to eye health innovation,” Jerry Warner, executive vice president, Americas and global commercial functions for CooperVision, said in the announcement. “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. eyecare professionals that will benefit countless kids throughout the country.”

Until now, traditional eyeglasses and contact lenses available in the U.S. have only been developed to correct blurred vision, which is a symptom of myopia, while not approved to slow its progression.

CooperVision said its research into MiSight 1 day’s effectiveness has been far-reaching. This includes the prospective, multi-center, double-masked, randomized multi-year study that enrolled 144 myopic children aged 8-12 years from Singapore, Canada, the United Kingdom and Portugal, which accounts for the FDA’s approved age range for initial fitting. Three-year peer-reviewed results published in Optometry and Vision Science in August 2019 indicated that use of MiSight 1 day was shown to slow myopia progression: 59 percent as measured by mean cycloplegic spherical equivalent (SE) and 52 percent as measured by mean axial elongation of the eye.

The trial has continued with highly encouraging results reported for years four and five, in which the original control group was refit into MiSight 1 day. This included older children, some of whom are now wearing the contact lens in their late teens.

“While there is growing acknowledgement and interest in stemming myopia’s progression, there needs to be more urgency to act earlier," said Michele Andrews, OD, senior director of North America professional and academic affairs for CooperVision. "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 eyecare professionals and passionate parents, we’re already making a meaningful difference in tackling myopia, and can now expand our efforts into the U.S."