CooperVision Presents Six-Year Data from MiSight® 1 Day Study; 23% of Eyes Showed No Additional Myopia Progression After Fitting

Rhea-AI Summary

CooperVision reported findings from its six-year MiSight® 1 day clinical study, revealing that 23% of children's eyes remained stable for myopia. The study highlighted the lens's efficacy in myopia management, demonstrating a continued excellent safety profile and visual acuity over 653 wearing years. Although early intervention is ideal, initiating treatment later can still effectively slow myopia progression. CooperVision's MiSight® is the only FDA-approved lens for this purpose in children aged 8-12, forming the core of its Brilliant Futures™ program, recently expanded to several countries.

Positive

• 23% of children's eyes showed no additional myopia progression after six years.
• MiSight® 1 day has a strong safety profile and visual acuity over 653 wearing years.
• The lens is FDA-approved for slowing myopia progression in children aged 8-12.
• Expanding the Brilliant Futures™ Myopia Management Program into countries like the UK, Canada, and Spain.

Negative

• None.

SAN RAMON, Calif., Oct. 9, 2020 /PRNewswire/ -- CooperVision is reporting the latest findings from its landmark MiSight^® 1 day clinical study, providing new insights about myopia management and the proven efficacy of the specially designed contact lens. Among many powerful outcomes are that nearly one in four children's eyes originally fit with MiSight^® 1 day remain stable for myopia after six years.¹

Paul Chamberlain, CooperVision's Director of Research Programs, will share additional details this evening, Friday, October 9 at 8:45 pm EST, during a paper presentation¹ at the American Academy of Optometry's virtual annual meeting.

"Evaluating children who were prescribed MiSight^® 1 day at the study's initiation, 23% of eyes after year six displayed a total refractive change of less than -0.25D (spherical equivalent), which could be considered clinically stable," said Chamberlain.¹ "There is now even more reason to recognize the substantial capability of this unique dual-focus contact lens."

The newest findings also suggest that while intervention at an early age is optimal with MiSight^® 1 day, commencing treatment at an older age could similarly slow the rate of myopia progression.¹ The original control group was refit into the dual-focus lens in year four. Comparing this population to the children fit with MiSight^® 1 day at initiation, there have been similar rates of myopia progression and axial length growth in the subsequent three years of assessment.¹ 

Six-year results continue to demonstrate excellent safety profile, wearing time, and visual acuity for children in daily disposable contact lenses over 653 wearing years.¹ No other prospective randomized controlled study has offered conclusive data for such a high degree of continued efficacy in myopia management using a soft contact lens over a similar time span.

Myopia—also known as nearsightedness or short-sightedness—is projected to affect the vision and increase risks to ocular health of approximately five billion people by 2050, more than doubling today's numbers.² Myopic progression has been linked to sight-threatening conditions later in life such as cataracts, retinal detachment, glaucoma³ and myopic maculopathy.⁴

Additional CooperVision Myopia Management Research at Academy 2020

Age is further explored in an Academy virtual poster session now underway. Effects of Age on Myopia Progression with Dual-Focus and Single Vision Daily Disposable Contact Lenses (Arumugam et al., 2020) concludes that observed treatment effects in myopia management clinical trials may be dependent on the age of the subjects and study duration. Annual axial elongation rates were slowed by wearing MiSight^® 1 day during every year for ages 8-14 and myopia progression significantly slowed for ages 8-13. These results also emphasize the importance of early intervention to slow pathological growth during years of more rapid progression. Early intervention also allows an accumulating management effect over more years, resulting in greater total outcomes.

CooperVision MiSight^® 1 day is the first and only soft contact lens the U.S. Food and Drug Administration has approved* for slowing the progression of myopia in children, who at initiation of treatment are 8-12 years of age.[5] It is the centerpiece of the company's Brilliant Futures™ Myopia Management Program, in which more than 1,000 U.S. ECPs are now certified. Versions of this comprehensive program are presently being introduced in other countries, including the United Kingdom, Canada, Spain and Portugal.

Reporting six-year data at Academy 2020 and ongoing research are part of a series of far-reaching initiatives by CooperVision to help educate eye care and healthcare professionals about advances in myopia management, including widespread conference participation, study support, clinical training events and more.

"As far as we have come with myopia management in recent years, there remains much to be done, including deeper partnerships with the optometry, ophthalmology and public health communities," said James Gardner, Vice President for Global Myopia Management at CooperVision. "We're a steadfast advocate for evidence-based advancements. I believe the six-year results will further our scientific understanding of myopia progression and increase clinical enthusiasm for proven management options such as MiSight^® 1 day."

*  Indications for use: MiSight® 1 day (omafilcon A) soft (hydrophilic) contact lenses for daily wear 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.

1 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: 6-year results (2020 American Academy of Optometry Annual Meeting).

2 Holden et al, - Global Prevalence of myopia and high myopia and temporal trends from 2000 through 2050. Ophthalmology 2016. 123(5):1036-1042

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

4 Macular Society. Myopia, Pathological Myopia and Myopic Macular Degeneration. Retrieved October 29, 2019 from: https://www.macularsociety.org/sites/default/files/resource/Macular%20Society%20Factsheet%20-%20Myopic%20Macular%20Degeneration%202017%20-%20ACCESS.pdf

5 Chamberlain P, et al. A 3-year randomized clinical trial of MiSight® lenses for myopia control. Optom Vis Sci. 2019; 96(8):556-567. Compared to a single vision 1 day lens over a 3 year period

About CooperVision
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.

About CooperCompanies
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. 

Media Contact
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mike@mcdougallpr.com or +1-585-434-2150

 

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SOURCE CooperVision

FAQ

What are the findings of the MiSight® 1 day clinical study by CooperVision?

The study found that 23% of children's eyes remained stable for myopia progression after six years.

Is MiSight® 1 day effective for treating myopia in children?

Yes, results indicate that MiSight® 1 day effectively slows myopia progression in children.

What age group is MiSight® 1 day approved for?

MiSight® 1 day is approved for children aged 8-12 for myopia management.

How long does the MiSight® study span?

The MiSight® clinical study spans six years.

What is the Brilliant Futures™ program associated with MiSight®?

Brilliant Futures™ is CooperVision's myopia management program, expanding into several countries.