Allergan Selected as Partner for National Eye Institute-Sponsored Macular Edema Studies.Business Editors IRVINE, Calif.--(BUSINESS WIRE)--April 28, 2004 Allergan, Inc. (NYSE NYSE See: New York Stock Exchange :AGN AGN Again (Amateur Radio) AGN Active Galactic Nucleus AGN Acute Glomerulonephritis AGN Accountants Global Network AGN Air Gabon (ICAO code) ) announced today that the company was selected as a partner to supply its novel ophthalmic formulation of triamcinolone triamcinolone /tri·am·cin·o·lone/ (tri?am-sin´o-lon) a synthetic glucocorticoid used in replacement therapy for adrenocortical insufficiency and as an antiinflammatory and immunosuppressant in a wide variety of disorders. for two National Eye Institute (NEI NEI National Eye Institute (NIH) NEI Nuclear Energy Institute NEI National Emission Inventory NEI Not Enough Information NEI Netherlands East Indies NEI Nuevos Estados Independientes )-sponsored clinical trials on macular edema (swelling of the retina). These multi-center, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. trials will investigate the efficacy and safety of the new intravitreal triamcinolone formulation for macular edema associated with diabetic retinopathy and retinal vein occlusion Retinal Vein Occlusion Definition Retinal vein occlusion refers to the closure of the central retinal vein that drains the retina or to that of one of its branches. . Macular edema associated with diabetic retinopathy will be studied through the Diabetic Retinopathy Clinical Research Network (DRCR DRCR Design Review Completion Report .net). Macular edema from retinal vein occlusion will be studied through the Standard Care versus Corticosteroid for Retinal Vein Occlusion (SCORE) study. Under the agreement, Allergan will be responsible for all costs associated with drug development, manufacturing, pharmacokinetic studies, and regulatory aspects of the trials. In addition, Allergan will pay a total of $1.8 million to the DRCR.net and SCORE coordinating centers for the conduct of the trials. "We are very pleased that we have been selected as a partner for these two NEI-sponsored trials," said Dr. Scott Whitcup, Senior Vice President and Head of the Ophthalmology Therapeutic Area at Allergan. "Macular edema is a common cause of vision loss in patients with a number of retinal diseases including diabetic retinopathy and retinal vein occlusion and there is clearly a need for effective treatments for these conditions." Macular edema affects approximately one to two million patients in the United States. Diabetic retinopathy is a complication of diabetes and a leading cause of blindness. It occurs when diabetes damages the tiny blood vessels inside the retina, the light-sensitive tissue at the back of the eye. Retinal vein occlusions are also a common cause of vision loss and occur when larger blood vessels inside the retina become blocked. In either condition, blurred vision may occur when the macula - the part of the retina that provides sharp, central vision - swells from the leaking fluid. This condition is called macular edema.(a) Previous studies suggest that intravitreal triamcinolone can significantly improve visual acuity (sharpness of vision) in patients with macular edema; however, the safety and efficacy of this treatment has not yet been proven in large, multi-center, randomized clinical trials. The NEI is one of the Federal government's National Institutes of Health, an agency of the U.S. Department of Health and Human Services Noun 1. Department of Health and Human Services - the United States federal department that administers all federal programs dealing with health and welfare; created in 1979 Health and Human Services, HHS . It was established by Congress in 1968 to discover safe and effective ways to prevent, diagnose, and treat eye diseases and disorders This is a partial list of human eye diseases and disorders. The World Health Organization publishes a classification of known diseases and injuries called the International Statistical Classification of Diseases and Related Health Problems or ICD-10. . The NEI is the major sponsor of vision research in the United States. Forward-Looking Statements The forward-looking statements in this press release relating to management's expectations and beliefs are based on preliminary information and management assumptions. Such forward-looking statements are subject to a wide range of risks and uncertainties that could cause results to differ materially from management's expectations and beliefs, including, among other things, those relating to product research and development, intellectual property rights and litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. , competitive products, results of clinical trials, the need for additional research and testing, delays in manufacturing, funding and the timing and content of decisions made by regulatory authorities, including the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. . About Allergan, Inc. Allergan, Inc., with headquarters in Irvine, California, is a technology-driven, global health care company providing eye care and specialty pharmaceutical products worldwide. Allergan develops and commercializes products in the eye care, neuromodulator, skin care and other specialty markets that deliver value to our customers, satisfy unmet medical needs, and improve patients' lives. (a) National Eye Institute, "What You Should Know About Diabetic Retinopathy." |
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