IRVINE, Calif., Jan. 30 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA) today announced that Edgar L. Thomas, M.D., of the Retina-Vitreous Associates Medical Group, presented integrated data from two Phase III clinical trials of Vitrase(R) (ovine hyaluronidase) for the treatment of vitreous hemorrhage (VH) in patients with diabetes at Hawaii 2004: the Royal Hawaiian Eye Meeting. Vitreous hemorrhage is a serious condition affecting the back of the eye for which there is currently no drug treatment.
Nearly 80 percent of the patients enrolled in two double-masked, placebo-controlled trials had a history of diabetes and approximately 90 percent of the patients could not read any letters on a vision chart at the beginning of the study. The results from the diabetic subset analysis showed that more than twice the number of patients treated with Vitrase(R) had a reduction in hemorrhage density compared to the control group as early as one month following a single intravitreous injection. This reduction in VH density allowed the investigator to see into the back of the eye to diagnose the underlying cause of the hemorrhage and treat with laser therapy when appropriate. For those patients with proliferative diabetic retinopathy as the likely cause for their hemorrhage, more than twice the number of those patients treated with Vitrase(R) were able to receive laser therapy as early as one month following a single intravitreal injection, as compared to those in the control group.
These Phase III clinical results were previously submitted to the U.S. Food & Drug Administration as part of ISTA's New Drug Application (NDA) for Vitrase(R) for vitreous hemorrhage and were publicly announced last year.
ISTA's Vitrase(R) is a proprietary formulation of highly purified ovine hyaluronidase, which has been studied for administration by injection into the vitreous of the eye.
ABOUT ISTA
ISTA is a specialty pharmaceutical company focused on the development and commercialization of unique and uniquely improved ophthalmic products. ISTA's product candidates and programs seek to address serious diseases and conditions of the eye such as vitreous hemorrhage, diabetic retinopathy, hyphema, glaucoma, ocular pain and inflammation. Building on this pipeline, ISTA's goal is to continue its growth as a specialty pharmaceutical company by acquiring complementary products, either already marketed or in late-stage development. For additional information regarding ISTA, please visit ISTA Pharmaceuticals' Website at www.istavision.com.
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements. ISTA disclaims any intent or obligation to update any forward-looking statements. These forward-looking statements are based on ISTA's expectations as of the date of this press release and are subject to risks and uncertainties that could cause actual results to differ materially from current expectations, including, but not limited to, such risks and uncertainties as detailed from time to time in ISTA's public filings with the U.S. Securities and Exchange Commission, including but not limited to ISTA's Annual Report on Form 10-K/A, as amended, for the year ended December 31, 2002 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2003.
SOURCE ISTA Pharmaceuticals, Inc.
CONTACT: Vince Anido, +1-949-788-5311, vanido@istavision.com, or Lauren Silvernail, +1-949-788-5302, lsilvernail@istavision.com, both of ISTA Pharmaceuticals; or Justin Jackson, Media, or Lisa Burns or E. Blair Schoeb, Investors, +1-212-213-0006, bschoeb@ny.burnsmc.com, all of Burns McClellan, for ISTA Pharmaceuticals, Inc.
