CooperVision announced it has received U.S. Food and Drug Administration (FDA) approval on Nov. 15, 2019 of its innovative MiSight® 1 day contact lens. The cornerstone of a comprehensive myopia management approach to be offered by CooperVision, 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 8-12 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. Eye care professionals who embrace this breakthrough approach will improve the quality of life and eye health for so many children."
Daniel G. McBride, President of CooperVision
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. 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."
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's 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% as measured by mean cycloplegic spherical equivalent (SE) and 52% 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.
CooperVision is more committed than ever to eye health innovation. 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."
Jerry Warner, Executive Vice President, Americas and Global Commercial Functions for CooperVision
MiSight® 1 day will launch in the U.S. as part of a CooperVision myopia management initiative beginning in March 2020. 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.
"Pediatric myopia has been increasing in prevalence and severity over the past few years, and my practice is always looking for new solutions, tools and ways to educate our patients and their parents about how to best manage their myopia," said Katherine Schuetz, OD, at Little Eyes Pediatric Care and RevolutionEYES. "With the FDA approval of MiSight® 1 day contact lens initially prescribed for kids 8 to 12 years old, eye care professionals finally have a solution designed specifically to slow the progression of myopia in those children. I'm even more confident since the lens is backed by years of clinical data and international in-market experience supporting their effectiveness."
Generally, myopia first occurs in school-age children and progresses until about age 202 According to a study published in Clinical Ophthalmology in August 2018, 41.9% of U.S. children ages 5-19 are myopic. This is due in part to changing lifestyles, with children spending less time outdoors and more time spent focusing on close objects such as digital screens.
"While there is growing acknowledgement and interest in stemming myopia's progression, there needs to be more urgency to act earlier. 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 eye 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.," said Michele Andrews, OD, Senior Director of North America Professional and Academic Affairs for CooperVision.