Pioneering, Clinically Proven Approach to Myopia Management Gaining Global Momentum
SAN RAMON, Calif., February 12, 2020—The Taiwan Food and Drug Administration has approved CooperVision’s innovative MiSight® 1 day contact lens, which is clinically proven to slow the progression of myopia (nearsightedness or short-sightedness) in children. The groundbreaking product is attracting surging global interest, helping eye care professionals and parents fight back against myopia’s rising prevalence and severity1.
“TFDA approval marks the latest milestone in the MiSight® 1 day story and speaks to our commitment to advancing myopia management science and clinical practice. We are elated about its potential to improve children’s quality of life and eye health in Taiwan,” said James Gardner, Vice President, Global Myopia Management for CooperVision. “MiSight® 1 day is now available in more than 20 countries and being worn by thousands of children. With today’s news, United States availability set to begin in March, our recent launch in Italy, and accelerating prescribing rates in other markets, that number will grow even higher.”
In Taiwan, myopia is estimated to affect 48% of children at age 10 and an astounding 80% at age 152. CooperVision plans to share more about its Taiwan introduction plans in the coming weeks.
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 cataracts3, retinal detachment3, glaucoma3 and myopic maculopathy4. Even children with mild prescriptions have a higher risk of glaucoma and retinal detachment later in life5, compared to their non-myopic peers, and the risk multiplies as their prescriptions get stronger6. 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.7”
CooperVision’s research into MiSight® 1 day’s effectiveness is far-reaching. This includes the prospective, multi-center, double-masked, randomized multi-year study that enrolled 144 myopic children from Singapore, Canada, the United Kingdom and Portugal,. 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 day8.
In November 2019, the MiSight® 1 day lens became the first and only product approved by the U.S. Food and Drug Administration9 for slowing the progression of myopia when initially prescribed for children 8-12 years old*. 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 eyecare industry media.
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, Chile, Israel, Singapore, Malaysia, Hong Kong, Taiwan, Australia and New Zealand.
1 Holden et al, - Global Prevalence of myopia and high myopia and temporal trends from 2000 through 2050. Ophthalmology 2016. 123(5):1036-1042
2 Rudnicka AR, Kapetanakis VV, Wathern AK, et alGlobal variations and time trends in the prevalence of childhood myopia, a systematic review and quantitative meta-analysis: implications for aetiology and early prevention. British Journal of Ophthalmology 2016;100:882-890.
3 What You Should Know if Your Child is Nearsighted (Infographic). Retrieved October 29, 2019 from: https://www.allaboutvision.com/parents/myopia-facts-infographic.htm
5 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.
6 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.
7 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.
8 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).
9 In the United States, 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.
* when compared to the children in the control group wearing a single vision 1-day contact lens.
CooperVision, a division of CooperCompanies (NYSE:COO), is one of the world’s leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; 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.
Jamie Palmeroni-Lavis, McDougall Communications
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