01.11.17

Paragon CRT Contact Lenses Approved by China Food & Drug Administration

Source: Paragon Vision Sciences

Paragon Vision Sciences 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 nonsurgical treatment option for managing myopia, 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, 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 5 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. 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.

Orthokeratology (also known as Ortho-K, corneal reshaping, and corneal refractive therapy [CRT]) is a nonsurgical 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,” 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, said in a company news release. "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,” Dr. Liu said. “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,” Richard Jeffries, president, Paragon Vision Sciences, said in the news release. “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.

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