Paragon CRT® Contact Lenses Approved by China Food & Drug Administration

MESA, Ariz., Jan. 11, 2017 /PRNewswire/ -- Paragon Vision Sciences, a world leader in orthokeratology, today announced China Food and Drug Administration (CFDA) approval and commercial availability of its corneal reshaping/ orthokeratology brand, Paragon CRT® Contact Lenses in China.   The contact lenses, a non-surgical treatment option for managing myopia (nearsightedness), the leading cause of vision impairment worldwide¹, are now available in 50 countries around the world, including the United States.

In China, one out of three people above the age of five suffers from myopia (a vision condition in which people can see close objects clearly, but objects farther away appear blurred) according to the National Visual Health White paper released in June 2016 by the China Health Development Research Center at Peking University. According to the report, in 2012 nearly 500 million people over the age of five had a visual defect in China, among which about 450 million had myopia. By 2020, nearly 700 million people are expected to have myopia in China—twice the population of the U.S.²

Generally, myopia first occurs in school-age children. Because the eye continues to grow during childhood, it typically progresses until about age 20.  In mainland China, Hong Kong, Taiwan, Japan, South Korea, and Singapore, the prevalence of myopia is between 80 percent and 90 percent in students completing secondary education.³   Later in life, if not treated properly, high levels of myopia may increase a person's risk of developing serious ocular health problems such as retinal damage, cataract and glaucoma, which can lead to vision loss and blindness.

Orthokeratology (also known as Ortho-K, corneal reshaping, and corneal refractive therapy [CRT]) is a non-surgical, option used to treat nearsightedness and low degrees of astigmatism using therapeutic contact lenses worn overnight. While asleep, the lenses gently reshape the front surface of the eye (cornea), resulting in clear vision the following day after the therapeutic CRT lenses are removed.

"Various optical approaches to the control of myopia progression have been evaluated over the past few decades, and numerous studies have demonstrated that overnight cornea-reshaping contact lenses are both a safe and effective treatment for slowing and reducing the progression of myopia in children," says Maria Liu, OD, PhD, assistant professor of clinical optometry at the University of California, Berkeley (UCB) and founder and chief of UCB's Myopia Control Clinic.  The clinic specializes in direct patient care and supervising optometry residents in optometric care of children and young adults with progressive or high myopia.

"Studies also have shown that 75 percent of children are capable of wearing corneal reshaping contact lenses⁴ and that this treatment method is as effective as other methods of treating myopia such as soft contact lenses, rigid gas permeable lenses, and eyeglasses in children," adds Dr. Liu. "Of course, selecting the appropriate vision correction option should be made after a discussion between the eye care practitioner, the parents, and the child."

"Dramatic increases in and projections for the prevalence of myopia world-wide are a serious public health concern," notes Richard Jeffries, president, Paragon Vision Sciences. "The practice of using overnight corneal reshaping with contact lenses to treat myopia is global and growing. With the availability of Paragon CRT® Contact Lenses in China, eye care practitioners have another evidence-based treatment option to help them treat myopia in children that may also contribute to preventing potential myopic-related ocular complications and vision loss from occurring later in life."

Essilor China will serve as the exclusive distributor for Paragon CRT® Contact Lenses in China.  The lenses will be widely available to eye care practitioners within the next few months.

About Paragon Vision Sciences
Paragon Vision Sciences is dedicated to improving lives through better vision.  For more than 40 years, Paragon Vision Sciences' commitment to research and development of advanced polymerizations for gas permeable materials, along with the company's sharp focus on technologically advanced ocular device design and superior manufacturing standards in the corneal reshaping/orthokeratology and scleral categories, has established Paragon as an industry leader in serving the global specialty contact lens market.  With over 1.5 million lenses sold in 50 countries, Paragon CRT® Contact Lenses are the choice of many eye care practitioners for the management of myopia.  For more information, visit www.paragonvision.com.

Important Information for Contact Lens Wearers: Paragon CRT® Contact Lenses are indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lenses are indicated for overnight wear with removal during all or part of each following day in a Corneal Refractive Therapy fitting program for the temporary reduction of myopia.  As with any contact lens, eye problems, including corneal ulcers, can develop. If a wearer experiences eye discomfort, excessive tearing, vision changes, or redness of the eye, immediately remove the lenses and do not wear them until instructed to do so by the eye care practitioner.

WARNING:  The risk of ulcerative keratitis has been shown to be greater among wearers of extended wear lenses than among wearers of daily wear lenses. The risk among extended wear lens wearers increases with the number of consecutive days that lenses are worn between removals, beginning with the first overnight use. This risk can be reduced by carefully following directions for routine lens care, including cleaning of the lens storage case.

Consult the package insert for complete information.  Complete information is also available from Paragon Vision Sciences by calling 1-800-528-8279 or by visiting www.paragonvision.com.

1. Bourne RR, Stevens GA, White RA, et al., Causes of vision loss worldwide, 1990-2010: a systematic analysis. The Lancet Global Health 2013; 1(6):e339–49.
2. Li L, Summary of National Vision Care Report, China Center for Health Development, National School of Development, Peking University, https://visionimpactinstitute.org/wp-content/uploads/2016/06/Summary-of-National-Vision-Care-Report.pdf Accessed December 31, 2016
3. Morgan IG, Ohno-Matsui K, Saw SM. Myopia. Lancet. 2012;379(9827):1739-1748
4. Walline JJ, Rah MJ, Jones LA., The Children's Overnight Orthokeratology Investigation (COOKI) pilot study. Optom Vis Sci. 2004 Jun;81(6):407-13. 3.

Paragon CRT® Contact Lenses are a trademark of Paragon Vision Sciences

SOURCE Paragon Vision Sciences

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