Paragon Vision Sciences has been granted approval by the US FDA for its Paragon CRT Corneal Refractive Therapy contact lens - this new approach involves wearing special contact lenses overnight to achieve corneal reshaping for the temporary reduction of myopia. The approval is the culmination of years of research and development including an extensive clinical study to establish the safety and efficacy of contact lens corneal reshaping in overnight use.
The study involved 11 investigational sites and 205 patients. It was designed for overnight lens wear only and patient follow-up was for nine months. Patients in the study achieved the following visual results based on binocular vision: 93.3% with 20/32 or better and 67.4% with 20/20 or better. In the FDA study lifestyle questionnaire, 91.7% of patients rated their post-treatment unaided daytime vision as good to excellent while rating their vision good to excellent at 91.5% with their previous vision correction modality. There were no serious adverse events reported in the study.
The approved indications cover individuals with up to -6.00 diopters of myopia with or without astigmatism up to -1.75 diopters. The approval also mandates that eye care practitioners be trained and certified specifically in the fitting and prescribing of Paragon CRT.
"For years many dedicated eye care professionals and pioneers have believed in the potential for overnight contact lens corneal reshaping," commented Dr. Jerome Legerton, one of the developers of Paragon's patent-pending design for contact lens corneal reshaping, Paragon CRT. "We are pleased to bring the nexus of science, research and documentation necessary to replace previous anecdotal information. Corneal Refractive Therapy, the FDA approved procedure, will now begin to move to the forefront of mainstream vision correction as a non-surgical option for eye care practitioners to offer their patients. Everyone will benefit."
"The excitement has been building at Paragon and throughout the ophthalmic community in anticipation of the FDA clearance," declared Joe Sicari, President and CEO of Paragon Vision Sciences. "Eye care professionals are now able to offer an exciting option to consumers who desire freedom from contact lenses and spectacles during their waking hours, but who do not elect surgery. Paragon CRT is the safe, effective and convenient non-surgical vision correction option consumers have been seeking." Continued Sicari, "The entire Paragon team including clinical investigators, outside consultants and Paragon's own research and development group, are to be congratulated for the dedicated, thoughtful and diligent work that has led us to this milestone. Now we will focus on bringing this opportunity to the market."
Paragon, in conjunction with their authorized laboratory partners, will officially launch Paragon CRT across the United States and Canada in Q3, 2004. Paragon will then turn its attention to Europe and, eventually, to worldwide distribution.