CooperVision DreamLite® Ortho-K Lenses Gain European Approval for Slowing Progression of Myopia

Rhea-AI Summary

CooperVision Specialty EyeCare announced the European approval of its Procornea DreamLite® night lenses for slowing myopia progression in children. This product adds to CooperVision's extensive portfolio, which includes MiSight® and SightGlass Vision technologies. A recent study revealed DreamLite lenses reduced axial length growth by 63% in high myopes. The increase in myopia prevalence globally is alarming, projected to affect 5 billion by 2050, leading to serious vision risks. The company's innovations aim to support eye care professionals in addressing this escalating issue.

Positive

• European approval of DreamLite night lenses enhances the product portfolio for myopia management.
• DreamLite lenses reduced axial length growth by 63%, demonstrating efficacy in myopia control.
• The approval strengthens CooperVision's position as a leader in myopia management.

Negative

• None.

SAN RAMON, Calif., May 25, 2021 /PRNewswire/ -- CooperVision Specialty EyeCare's Procornea DreamLite^® night lenses have received European approval for slowing the progression of myopia in children and young adults. The popular orthokeratology contact lens is the latest CooperVision myopia control product to gain the CE Mark, joining EyeDream and Paragon CRT^® ortho-k designs, MiSight^® 1 day soft contact lenses, and SightGlass Vision Diffusion Optics Technology spectacle lenses.

CooperVision has built the world's largest portfolio of evidence-based myopia control interventions. This provides eye care professionals (ECPs) with multiple approved options for addressing the global myopia epidemic, helping them tailor the approach to each child and family.

"Myopia's increasing frequency and prevalence is one of the most discussed issues in eye health. But conversation without action will not change the lives of the hundreds of millions of children affected by the issue. That sentiment is echoed by the World Council of Optometry, which recently passed a resolution advising optometrists to incorporate a standard of care for myopia management within their practices," said Dr. Juan Carlos Aragón, President, CooperVision Specialty EyeCare.

"Our commitments to innovations such as DreamLite^® night lenses, providing broader access to optical interventions with scientifically-demonstrated outcomes, and investing in widespread education for eye care professionals and parents are examples why CooperVision continues to lead the myopia management category. The latest CE Mark will help ECPs communicate with even more confidence about DreamLite^® lenses' ability to slow the progression of myopia."

DreamLite® night lenses can be used for myopia control with children who have a refraction of -0.75 D to -5.00 D and a cylindrical refraction with a maximum of -2.50 D. A two-year study showed that DreamLite® night lenses reduced axial length growth by 63% percent among high myopes compared to the single vision spectacle lens control group—a total reduction of 0.32 mm.¹ The lenses are currently available across Europe, the Middle East, and China.

CooperVision products are used by thousands of ECPs across the region for myopia correction and control. DreamLite® ortho-k lenses represent the leading design in the United Kingdom (under the EyeDream brand), and MiSight^® 1 day soft contact lenses are available in multiple countries for daily wear. Commercialization plans are in progress for SightGlass Vision Diffusion Optics Technology^™ spectacle lenses, which CooperVision acquired earlier this year.

In November 2019, MiSight^® 1 day became the first and only U.S. Food and Drug Administration-approved^* soft contact lenses proven to slow myopia progression in children, aged 8-12 at the initiation of treatment.^2** This pivotal development and subsequent adoption by thousands of influential ECPs has accelerated myopia management in the U.S. and other countries.

Myopia is projected to affect the vision of approximately five billion people globally by 2050, more than doubling today's numbers.³ High myopia raises the risk of vision-threatening eye conditions such as retinal detachment, glaucoma, early cataracts and myopic maculopathy, a leading cause of blindness world-wide.⁴

* U.S. 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.

** 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 contact lenses. The company produces a full array of daily disposable, two-week and monthly soft contact lenses that feature advanced materials and optics, and premium rigid gas permeable lenses for orthokeratology and scleral designs. CooperVision has a strong heritage of addressing the toughest vision challenges such as astigmatism, presbyopia, childhood myopia, and highly irregular corneas; and offers the most complete portfolio 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
Mike McDougall, McDougall Communications for CooperVision
mike@mcdougallpr.com or +1-585-434-2150

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¹ Charm J, Cho P. High myopia-partial reduction ortho-k: a 2-year randomized study. Optom Vis Sci. 2013 Jun;90(6):530-9. doi: 10.1097/OPX.0b013e318293657d. PMID: 23645372.

² Chamberlain P, et al. A 3-year randomized clinical trial of MiSight® lenses for myopia control. Optom Vis Sci. 2019; 96(8):556-67.

³ Holden et al, - Global Prevalence of myopia and high myopia and temporal trends from 2000 through 2050. Ophthalmology 2016. 123(5):1036-1042

⁴ Tideman JW et al. Association of axial length with risk of uncorrectable visual impairment for Europeans with myopia. JAMA Ophthalmol. 2016;134:1355-1363.

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SOURCE CooperVision

FAQ

What is the significance of the CE Mark for CooperVision's DreamLite lenses?

The CE Mark indicates regulatory approval for DreamLite lenses to slow myopia progression, enhancing their market credibility.

When was the European approval for DreamLite lenses announced?

The approval was announced on May 25, 2021.

What are the expected outcomes of using DreamLite lenses according to studies?

Studies showed that DreamLite lenses reduced axial length growth by 63% in high myopes.

How many people are projected to be affected by myopia globally by 2050?

Approximately 5 billion people are projected to be affected by myopia by 2050.

What does the DreamLite lens approval mean for CooperVision's market position?

It strengthens CooperVision's role as a leader in myopia management solutions for eye care professionals.