To: David Bogdanoff who wrote (947 ) 6/18/1999 11:23:00 AM From: bob zagorin Respond to of 1060
Thursday June 17, 4:02 pm Eastern Time Company Press Release InSite Vision Announces Positive Results of Phase II Glaucoma Therapeutic Study ALAMEDA, Calif.--(BW HealthWire)--June 17, 1999--InSite Vision Incorporated (AMEX:ISV - news) today announced the positive results of its ISV-205 Phase II glaucoma therapeutic study. Pharmacia & Upjohn, Inc., (P&U), licensed ISV-205 from InSite Vision earlier this year and will be leading the continued clinical development of the product, with InSite's technical assistance, and will market the product if it receives FDA approval. ''These exciting results add a new dimension to the current glaucoma therapy,'' Dr. Chandrasekaran said. ''For the first time in the history of glaucoma management, we now have a drug that treats an important cause of the disease rather than its symptoms. ISV-205 has the potential of stopping the progress of the disease.'' Glaucoma is the leading cause of preventable blindness in the United States. Recent evidence indicates that the disease is caused by changes in the TIGR gene in glaucoma patients. These changes may lead to overproduction of the TIGR protein, which may plug up the drainage system of the eye, resulting in a buildup of pressure in the eye and optic nerve damage associated with glaucoma. ISV-205 is a special formulation of diclofenac, a non-steroidal anti-inflammatory drug (NSAID) delivered to the eye using InSite Vision's proprietary sustained-release DuraSite® technology. This technology enables the effective treatment of glaucoma by reaching higher concentrations and longer residence time of diclofenac inside the eye. ISV-205 was shown in various preclinical studies to inhibit the production of TIGR protein in the cells that line the drainage system of the eye. The current study provides the first evidence that ISV-205 is effective in treating the disease by blocking TIGR protein production in humans. Analysis of the data from the Phase II study showed that ISV-205 was safe and effective in reducing, by 75%, the number of subjects with clinically significant intraocular pressure elevations. Overall, ISV-205 markedly blunted the pressure rise during the six week dosing period. The study included 136 first degree relatives of glaucoma patients who were challenged with corticosteroids. A second Phase II study including a larger patient population is anticipated to be initiated this year. This press release contains, among other things, certain statements of a forward-looking nature relating to future events or the future business performance of InSite Vision. Such statements entail a number of risks and uncertainties involving the results of preclinical and clinical studies and determinations by the U.S. Food and Drug Administration, as well as the Risk Factors listed from time to time in the company's SEC filings including, but not limited to, its Form 10-Q for the quarter ended March 31, 1999. -------------------------------------------------------------------------------- Contact: InSite Vision Incorporated Sandra Heine, 510/865-8800 or Core Communications Group, Inc. Robert Ferri, 415/331-7003 San Francisco (IR) rferri@nextwavestocks.com Joshua Z. Levine, 516/487-8322 New York (IR) jzlevine@nextwavestocks.com -------------------------------------------------------------------------------- More Quotes and News: Insite Vision Inc (AMEX:ISV - news) Related News Categories: biotech, medical/pharmaceutical -------------------------------------------------------------------------------- Help