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Copyright 2003 |
| Paragon
Vision Sciences Receives Approval for Corneal Refractive Therapy for Overnight Contact Lens Corneal Reshaping - the First Approval for
This Indication.
Mesa, Arizona - June 13, 2002 - Today Paragon Vision Sciences received FDA approval for Paragon CRT®, its Corneal Refractive Therapy contact lens, for overnight contact lens corneal reshaping for the temporary reduction of myopia. This is the first approval for this overnight indication. The issuance of this approval is the culmination of Paragon's years of research and development including the most extensive clinical study to date 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 proprietary, 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 this summer. Paragon will then turn its attention to Europe and, eventually, to worldwide distribution. Paragon CRT with Proximity Control Technology™ offers eye care practitioners a unique lens design. Unlike traditional designs such as reverse geometry, Paragon CRT is a single lens modality that utilizes design elements such as a sigmoid return zone permitting an unprecedented level of fitting control and predictability. The Paragon CRT lens design also features a straight-angle landing zone providing a safe, non-impinging lens periphery. The Paragon CRT lens will be featured in Paragon HDS® 100 material and available, upon request, in Paragon HDS®. "Paragon CRT is more than an extraordinary lens design," observed Tim Koch, FCLSA and Paragon's Director of Clinical Affairs and Professional Development. "Paragon CRT is a complete approach to overnight contact lens corneal reshaping including an in-office diagnostic dispensing system that will permit practitioners to dispense nearly 80% of patients immediately following the initial eye exam. The Paragon CRT system will also provide software exclusively for the Humphrey® ATLAS™ topographer for integrating corneal topography to deliver even greater office efficiency. State-of-the-art manufacturing produces micron level accuracy and lens reproducibility and professional education and consultation will be available utilizing the latest interactive multimedia. Additionally, Paragon will offer a complete package to assist the practitioner in effectively presenting the option of Corneal Refractive Therapy to patients." As with all of its GP materials, Paragon will exclusively recommend Alcon's Unique pH® multi-purpose solution for the proper care and disinfection of Paragon CRT lenses. Paragon Vision Sciences is a privately held, specialty vision products company located near Phoenix in Mesa, Arizona, which is owned and operated by Joseph Sicari, President & CEO and members of his management team. Paragon is the manufacturer of world-renowned oxygen permeable contact lens materials including Paragon HDS®, Paragon HDS® 100, Paragon Thin™, FluoroPerm®, Paraperm® and SportSight® GP. For more information on Paragon CRT contact an Authorized Paragon CRT Laboratory Partner, the company's customer service team at 1-800-528-8279 within the United States and Canada or 1-480-892-7602 from other countries or log on to www.paragoncrt.com. Company and general product information is also available on the company's website: www.paragonvision.com. |