CollaGenex Pharmaceuticals Initiates Clinical Study of Periostat in Patients with Meibomianitis, a "Dry Eye" Syndrome.Business Editors/Health & Medical Writers NEWTOWN, Pa.--(BUSINESS WIRE)--June 17, 2002 Disease affects 15 million adults in the U.S., with no FDA-approved systemic therapy for this disease. CollaGenex Pharmaceuticals, Inc. (Nasdaq:CGPI CGPI Corporate Goods Price Index (Japan) CGPI Capital Goods Price Index (New Zealand) ) today announced that it has initiated a multi-center, double-blinded, placebo-controlled clinical study to evaluate the efficacy of its product, Periostat(R), for the treatment of meibomianitis, also known as ocular rosacea and characterized by symptoms of "dry eye". There is currently no FDA-approved systemic treatment for meibomianitis. The study, which will enroll 70 patients, is being conducted by Edward Holland, M.D., Professor of Clinical Ophthalmology at the University of Cincinnati The University of Cincinnati is a coeducational public research university in Cincinnati, Ohio. Ranked as one of America’s top 25 public research universities and in the top 50 of all American research universities,[2] and Director of Cornea cornea: see eye. Service at the Cincinnati Eye Institute, Stephen Lane, M.D., Clinical Professor of Cornea and External Diseases at the University of Minnesota (body, education) University of Minnesota - The home of Gopher. http://umn.edu/. Address: Minneapolis, Minnesota, USA. and Refractive refractive capacity to refract light. refractive error a difference between the focal length of the cornea and lens, and the length of the eye, resulting in myopia or hyperopia. Surgeon at Associated Eye Care located in Stillwater, MN, and Janine Tabas, M.D., Associate Clinical Professor at the Wills Eye Hospital, Philadelphia, PA and Cataract and Refractive Surgeon at Kay & Tabas Ophthalmology Associates in Bala Cynwyd, PA. "Meibomianitis is a chronic inflammatory disease, with no cure," said Dr. Edward Holland. "The primary mode of treatment is to administer doxycycline doxycycline /doxy·cy·cline/ (dok?se-si´klen) a semisynthetic broad-spectrum tetracycline antibiotic, active against a wide range of gram-positive and gram-negative organisms; used also as d. calcium and d. hyclate. at doses of 100 to 200 mg per day, along with daily eyelid eyelid /eye·lid/ (-lid) either of two movable folds (upper and lower) protecting the anterior surface of the eyeball. eye·lid or eye-lid n. hygiene, for long periods of time. This treatment regimen often leads to significant side effects, primarily nausea and diarrhea, and also increases the risk of developing microbial microbial pertaining to or emanating from a microbe. microbial digestion the breakdown of organic material, especially feedstuffs, by microbial organisms. resistance. Anecdotal evidence suggests that Periostat, a 20-mg formulation of doxycycline, may be equally effective in treating meibomianitis without the side effects of high dosage antibiotics." "The potential to treat meibomianitis with Periostat is based on our knowledge and in-depth understanding of certain mechanisms of action occurring in inflammatory diseases, as well as numerous anecdotal reports from current patients that their dry eye symptoms improved while taking Periostat for periodontitis periodontitis Inflammation of soft tissues around the teeth (see tooth). Poor dental hygiene leads to deposition of bacterial plaque on the teeth below the gum line, irritating and eroding nearby tissues. ," said Brian M. Gallagher, PhD, chairman, president and chief executive officer of CollaGenex. "Periostat, the first FDA-approved and commercialized product from our IMPACs technology, has demonstrated the ability to inhibit a number of destructive proteases and cytokines Cytokines Chemicals made by the cells that act on other cells to stimulate or inhibit their function. Cytokines that stimulate growth are called "growth factors. involved in inflammatory processes. We look forward to obtaining the results of this trial, and the potential to offer a novel treatment for patients suffering from this disease." Meibomianitis is the most frequent diagnosis made by ophthalmologists, affecting more than 15 million people in the United States. The disease is characterized by a chronic inflammation and dysfunction of the meibomian glands, which are located on the eyelids and produce the lipids that comprise the surface layer of tears. Meibomian gland dysfunction often leads to alterations in the composition of tears, causing patients to experience pain, ocular redness, light sensitivity, dry eye and decreased visual acuity. Symptoms can be ameliorated through the application of artificial tears and other topical applications, although there currently is no FDA-approved systemic medication for meibomianitis. CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical company currently focused on providing innovative medical therapies to the dental and dermatology markets. Currently, the Company's 120-person professional dental pharmaceutical sales force markets Periostat, the first and only pharmaceutical to treat periodontal disease by inhibiting the enzymes that destroy periodontal support tissues, Vioxx(R), a Merck & Co. drug that CollaGenex co-promotes for the treatment of acute dental pain, and Atridox(R), Atrisorb(R) and Atrisorb-D(R), Atrix Laboratories Inc.'s products for the treatment of adult periodontitis. Research has shown that the enzyme suppression technology underlying Periostat may also be applicable to other diseases involving inflammation and/or destruction of the body's connective tissues, including acne, rosacea Rosacea Definition Rosacea is a skin disease typically appearing in people during their 30s and 40s. It is marked by redness (erythema) of the face, flushing of the skin, and the presence of hard pimples (papules) or pus-filled pimples (pustules), and , meibomianitis and cancer metastases Metastasis (plural, metastases) A tumor growth or deposit that has spread via lymph or blood to an area of the body remote from the primary tumor. Mentioned in: Malignant Melanoma , among others. CollaGenex is further developing Periostat as well as a series of novel, proprietary compounds known as IMPACS (Inhibitors of Multiple Proteases and Cytokines) to address these applications. To receive additional information on the Company, please visit our Web site at www.collagenex.com, which is not a part of this press release. Periostat(R), and IMPACS(R) are trademarks of CollaGenex Pharmaceuticals, Inc. VIOXX(R)is a trademark of Merck & Co., Inc. Atridox(R), Atrisorb(R) and Atrisorb-D(R) are trademarks of Atrix Laboratories, Inc. |
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