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| |  New Drug Likely To Be Effective Treatment In Leading Cause Of Blindness FT. LAUDERDALE, May 12, 1997 -- Data presented yesterday at the annual meeting of the Association of Research in Vision and Ophthalmics confirms the potential of a new drug to halt the deterioration of sight caused by Age-related Macular Degeneration (AMD), the leading cause of blindness in persons over the age of 50. The new drug is called Benzoporphyrin derivative (BPD-MA Sverteporfin) and is being co-developed by QLT PhotoTherapeutics Inc. (QLT) and CIBA Vision Corporation. The severe or "wet" form of AMD is caused by the rapid growth of abnormal blood vessels under the central retina. These abnormal vessels leak fluid causing scarring and a steady loss of visual acuity. Results of Phase I/II clinical trials investigating BPD-MA as a treatment for AMD show that BPD-MA can selectively close abnormal leaking blood vessels, without causing the vision loss associated with currently-available treatments. BPD-MA is used in a two-step medical procedure known as photodynamic therapy. The drug is first administered intravenously and circulates in the blood where it rapidly accumulates preferentially in the abnormal blood vessels. The drug has no effect until it is activated by light from a non-thermal laser which then causes occlusion of the abnormal blood vessels associated with AMD. Commenting on the presentations made on Sunday, Dr. Julia Levy, President and CEO of QLT, says the new data shows that optimum dosage prevents leakage in abnormal blood vessels for up to three months and that patients can tolerate multiple treatments without any evidence of vision loss attributable to the treatment. A multi-center Phase III clinical trial investigating BPD-MA for the treatment of AMD is already underway at 22 sites throughout Canada, the U.S. and Europe. The BPD-MA clinical trials program is directed by Dr. Neil Bressler of the Wilmer Ophthalmological Institute, at the Johns Hopkins Medical Institutions, in Baltimore, Maryland. "These Phase I/II clinical results validate and confirm our earlier studies that show BPD-MA may be an effective treatment for AMD," says Dr. Bressler. "The Phase III trials are designed to demonstrate effectiveness in a larger number of patients and in a more definitive way." The Phase I/II results were presented in Fort Lauderdale by Dr. Ursula Schmidt-Erfurth of the University Eye Hospital of Lubeck, Germany; Dr.Evangelos S. Gragoudas of the Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, Massachusetts; and Dr. Michel Sickenberg of Hopital Ophtalmique Universitaire of Lausanne, Switzerland. In Sunday's first presentation, a multi-center trial involving more than 100 patients who received a single treatment of BPD-MA, confirmed preliminary results released in 1996. Partial or complete absence of leakage from diseased blood vessels responsible for wet AMD was demonstrated in all lesions post-treatment, usually without any significant visual loss. No significant reduction in vision was identified on three month follow-up, at optimum doses. In the second presentation, a Phase I/II clinical research study, exploring for the first time the effects of multiple treatments, indicated that AMD patients can be re-treated with BPD-MA and the therapeutic benefit may be repeated and often improved. The study, involving more than 40 patients who received either two or three treatments, suggested that the area of leakage was reduced upon re-treatment without any negative impact or vision loss. In the third presentation, patients with abnormal growth of blood vessels in the eye that were not caused by AMD (but rather pathologic or progressive myopia, infection, or other unknown causes), responded positively to BPD-MA treatment. These promising preliminary results will be further tested in larger patient populations in a phase III clinical trial with BPD-MA for the treatment of abnormal blood vessels due to pathologic myopia set to begin later this year. Although the incidence of abnormal blood vessels in pathologic myopia is much less than that for AMD and vision loss occurs at a slower rate, it affects patients 20 to 30 years younger than those with AMD. Based on proprietary market research, QLT and CIBA Vision estimate that approximately 2.5 million people in developed countries suffer from the severe or "wet" form of AMD. Approximately 200,000 new cases of the wet form are diagnosed annually. Headquartered in Atlanta, Georgia, USA, CIBA Vision is engaged in research, development and manufacturing of optical and ophthalmic products and services, including contact lenses, lens care products, and ophthalmic pharmaceuticals. CIBA Vision has operations in more than 60 countries. QLT PhotoTherapeutics is engaged in the development and commercialization of proprietary pharmaceutical products for photodynamic therapy, a field of medicine that utilizes light-activated drugs in the treatment of cancer, diseases of the eye and other medical conditions.
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