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Copyright 2003 |
For Immediate
Release: Mesa, Arizona – April 2003: Paragon Vision Sciences is pleased to announce the US Food and Drug Administration (FDA) has granted approval of the Company’s Investigational Device Exemption (IDE) application for clinical study of Corneal Refractive Therapy for presbyopia using the Paragon CRT® design platform. The commencement of this study represents the further expansion of Paragon’s technological leadership in this emerging business segment. Presbyopia is the inability of the aging eye to adjust focus from far to near. About 35% of all persons in United States are presbyopic. Paragon CRT is currently the only system for contact lens Corneal Refractive Therapy approved by the FDA for overnight use in the correction of myopia. This study will utilize the principles of the Paragon CRT design and prescribing system to manage the presbyopic condition while correcting distance vision in patients with or without myopia and astigmatism. “We are excited about the potential scientific benefit that this new non-surgical corneal reshaping therapeutic lens can provide to presbyopic patients,” noted Joe Sicari, President and C.E.O. of Paragon Vision Sciences. “The segment of the population with presbyopia is rapidly growing and many of these consumers are asking for options that provide visual freedom during the day, including freedom from the use of reading glasses. The Paragon CRT for presbyopia study is the next step in bringing this non-surgical corneal reshaping option to market. Eye care practitioners who become involved now with the current Paragon CRT lens design platform for myopia will be ready to not only fit new patients with the Paragon CRT presbyopic lens design but transition patients from our myopic design to the presbyopic design fluidly.” The next generation clinical study will start early next month to evaluate the use of therapeutic lens corneal reshaping in overnight use for temporary reduction of presbyopia. The study eventually will include over 200 patients at 15 locations throughout the US. “This will probably be the most in-depth clinical investigation of presbyopic treatment using contact lenses ever conducted for FDA approval. While previous device studies have failed to rule out the possibility of placebo effect we have incorporated numerous new procedures to demonstrate both subjectively and objectively how the lens will perform and the level of the unaided vision upon removal under all likely environmental conditions. Most previous bifocal contact lens approaches are successful only with early presbyopes having residual accommodation. Final approval of this product will signify a real step forward in the treatment of presbyopia” Commented Bill Meyers, PhD, Paragon’s Vice-President, Science & Technology. Paragon CRT is manufactured with exacting standards, exclusively by Paragon with Paragon HDS® 100, an HDS Technology® material. The existing FDA clearance for Paragon CRT is up to –6.00 diopters of myopia with or without astigmatism up to –1.75 diopters and with no age restriction. Paragon HDS 100 also holds FDA clearance for up to 7 days of continuous wear in standard GP lens designs. Paragon CRT is the ideal vision correction option for consumers that desire freedom from the hassles of contact lenses and spectacles during their waking hours, but prefer a non-surgical vision correction alternative. Paragon CRT provides 24-hour vision (the patient can see with the lenses on or off) without the inconvenience of daytime contact lenses and, importantly, allows the eye-unencumbered access to oxygen throughout waking hours. Corneal Refractive Therapy with Paragon CRT provides an opportunity for practitioners not involved with refractive surgery to compete in the corneal reshaping market with a temporary, non-surgical and reversible option. For practices involved in refractive surgery, Paragon CRT is an ideal complement as it offers an exiting opportunity for those patients underage for refractive surgery and those people of all ages who are averse to surgery. Paragon CRT also provides a “test drive” of the visual freedom that surgery provides. This experience may lead patients to elect surgery in the future. Paragon, in conjunction with a select group of authorized laboratory partners, officially launched Paragon CRT across the United States in August 2002. Each Paragon CRT eye care practitioner must be trained and certified to fit the product. In 2003, Paragon CRT will become widely available in Canada and eventually worldwide. Specific information for practitioners and patients about Paragon CRT can be obtained at the product web page: www.paragoncrt.com. Paragon Vision Sciences is a privately held, specialty vision products company, located near Phoenix in Mesa, Arizona, which is owned and operated by Joe 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 and other Paragon products contact an Authorized Paragon Laboratory Partner or 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. Information can also be obtained on the company’s Internet Web page: www.paragonvision.com. |