FDA Approval Offers New Prospects for Parents, Children and Medical Professionals;
Will Become the First and Only Product of its Kind Available in the U.S.
SAN RAMON, Calif., November 18, 2019—CooperVision announced today it has received U.S. Food and Drug Administration (FDA) approval of its innovative MiSight® 1 day contact lens1. 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 product1 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,” said 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 cataracts2, retinal detachment2, glaucoma2 and myopic maculopathy3. Even children with fairly mild prescriptions have a higher risk of glaucoma and retinal detachment later in life4, compared to their non-myopic peers, and the risk multiplies as their prescriptions get stronger5. 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.6”
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 fitting1. Three-year peer-reviewed results published in Optometry and Vision Sciences 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 day7. 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,” said 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 vary7. 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 years8, 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 old1, 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 myopic9. 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.
To learn more, please visit coopervision.com/practitioner/myopia-management.
MiSight® 1 day contact lenses are currently approved for sale in the United States, Canada, the United Kingdom, France, Spain, Portugal, Netherlands, Belgium, Germany, Austria, Switzerland, the Nordic Region, Singapore, Malaysia, Hong Kong, Australia and New Zealand. MiSight® 1 day is not approved in Japan.
1 MiSight® (omafilcon A) daily wear single use Soft Contact Lenses are indicated for the correction of myopic ametropia and for slowing the progression of myopia in children with non-diseased eyes, who at the initiation of treatment are 8-12 years of age and have a refraction of -0.75 to -4.00 diopters (spherical equivalent) with ≤ 0.75 diopters of astigmatism. The lens is to be discarded after each removal.
2 What You Should Know if Your Child is Nearsighted (Infographic). Retrieved October 29, 2019 from: https://www.allaboutvision.com/parents/myopia-facts-infographic.htm
3 Macular Society. Myopia, Pathological Myopia and Myopic Macular Degeneration. Retrieved October 29, 2019 from: https://www.macularsociety.org/macular-disease/macular-conditions/myopic-macular-degeneration/
4 Flitcroft, D. (2012). The complex interactions of retinal, optical and environmental factors in myopia aetiology. Progress in Retinal and Eye Research. 31(6): 622-660.
5 Bourne RR, Stevens GA, White RA, Smith JL, Flaxman SR, Price H et al. Causes of vision loss worldwide, 1990-2010: a systematic analysis. Lancet Global Health. 2013;1:e339–e349.
6 The Impact of Myopia and High Myopia. Report of the Joint World Health Organization-Brien Holden Vision Institute Global Scientific Meeting on Myopia. University of New South Wales, Sydney, Australia. 16-18 March 2015.
7 Chamberlain P, Logan N, Jones D, Gonzalez-Meijome J, Saw S-M, Young G. Clinical evaluation of a dual-focus myopia control 1 day soft contact lens. 3-year results (2016 American Academy of Optometry Annual Meeting) and 5-year results (2019 BCLA Clinical Conference & Exhibition).
8 Holden et al, - Global Prevalence of myopia and high myopia and temporal trends from 2000 through 2050. Ophthalmology 2016. 123(5):1036-1042
9 Theophanous C, Modjtahedi BS, Batech M, Marlin DS, Luong TQ, Fong DS. Myopia prevalence and risk factors in children. Clin Ophthalmol. 2018;12:1581–1587. Published 2018 Aug 29. doi:10.2147/OPTH.S164641
* when compared to the children in the control group wearing a single vision 1-day contact lens.
CooperVision, a unit of CooperCompanies (NYSE:COO), is one of the world’s leading manufacturers of soft contact lenses. The Company produces a full array of monthly, two-week and daily disposable contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism and presbyopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com.
CooperCompanies ("Cooper") is a global medical device company publicly traded on the NYSE (NYSE:COO). Cooper operates through two business units, CooperVision and CooperSurgical. CooperVision brings a refreshing perspective on vision care with a commitment to developing a wide range of high-quality products for contact lens wearers and providing focused practitioner support. CooperSurgical is committed to advancing the health of women, babies and families with its diversified portfolio of products and services focusing on medical devices and fertility & genomics. Headquartered in San Ramon, Calif., Cooper has a workforce of more than 12,000 with products sold in over 100 countries. For more information, please visit www.coopercos.com.
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