IRVINE, Calif., May 1 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. announced today details of two scientific poster presentations that describe the first predictive model for treatment success with Vitrase(R) (Ovine Hyaluronidase) in managing vitreous hemorrhage associated with diabetes. Incorporating data from a pooled, subset analysis of the Company's two randomized, double-masked, placebo-controlled Phase III clinical studies of Vitrase(R) for the treatment of vitreous hemorrhage, the posters, entitled "A Simple Predictor of Vitrase(R) Efficacy for BCVA Improvement in Diabetic Patients With Severe Vitreous Hemorrhage" and "A Simple Predictor of Vitrase(R) Efficacy for Successful Laser Treatment in Diabetic Patients With Severe Vitreous Hemorrhage," were presented during the 2006 annual meeting of The Association for Research in Vision and Ophthalmology (ARVO) in Fort Lauderdale, FL.
According to the subset analysis of patients with diabetes from the Vitrase Phase III studies, a relatively simple measurement for the density of vitreous hemorrhage ("Total Hemorrhage Point Score," or THPS) allowed prediction of treatment success following a single intravitreous injection of 55 IU or 75 IU Vitrase. Specifically, THPS at one month was a predictor of treatment success with Vitrase as measured by best corrected visual acuity (BCVA) of three or more lines on an eye chart at three months when compared to a single injection of saline solution (p < .0001 or p< .0003 for 55 IU or 75 IU Vitrase, respectively). THPS at one month was also a predictor of treatment success with Vitrase as measured by completion of panretinal laser photocoagulation by three months without vitrectomy when compared to a single injection of saline solution (p < .0001 or p< .0003, for 55 IU or 75 IU Vitrase, respectively).
"The existing Phase III data on our thimerosal-free Vitrase to manage vitreous hemorrhage, a serious and severely debilitating eye ailment, is further reinforced by this subset analysis of treatment predictors in patients with diabetes," stated Lisa R. Grillone, Ph.D., Vice President of Clinical Research at ISTA Pharmaceuticals. "For the first time, clinicians can be provided with a tool for managing vitreous hemorrhage patient, and using this model, can predict treatment success one month post-injection."
About the Vitrase Phase III Clinical Trials
A total of 1,306 patients were enrolled in two randomized, double-masked, placebo-controlled international Phase III studies. The 750 patients enrolled in the North American study were assigned to one of four treatment arms (saline injection, 7.5 IU, 55 IU or 75 IU Vitrase injection), while the 556 patients treated in the second study outside North America were assigned to one of three treatment arms (saline injection, 55 IU or 75 IU Vitrase injection). In both studies, patients with a vitreous hemorrhage for at least one month were enrolled if their hemorrhage was designated as severe and their best-corrected visual acuity in the study eye was worse than 20/200 at the time of entry into the study. Treatment success for the primary (surrogate) endpoint in both studies was defined as the clearance of vitreous hemorrhage sufficient to allow the diagnosis and appropriate treatment, if needed, of the underlying cause of the vitreous hemorrhage within three months following treatment. Additionally, at each study visit and specifically at months one, two and three following treatment, BCVA was assessed using an eye chart.
ABOUT VITRASE(R)
ISTA's Vitrase(R) is a proprietary formulation of highly purified ovine hyaluronidase. In May 2004, the FDA approved Vitrase(R) in a lyophilized 6200 USP Units multi-purpose vial for use as a spreading agent, for hypodermoclysis and as an adjunct in subcutaneous urography; a 200 USP Units/mL vial in sterile solution for such indications was approved by the FDA in December 2004. FDA's approval of Vitrase(R) for use as a spreading agent in May 2004 removed hyaluronidase from the FDA's drug shortage list where it had been listed since 2001.
In addition to its approval by FDA for use as a spreading agent, for hypodermoclysis and as an adjunct in subcutaneous urography, Vitrase(R) has been studied for the treatment of vitreous hemorrhage. ISTA filed a New Drug Application (NDA) with the FDA for the treatment of vitreous hemorrhage in 2002 and an approvable letter for that NDA was received in 2003. In the letter, the FDA cited issues primarily related to the sufficiency of the efficacy data submitted with the NDA. The FDA requested additional analysis of the existing data and an additional confirmatory clinical study based upon that analysis. We are continuing to discuss with the FDA the clinical issues raised in the approvable letter and will determine the next appropriate steps based on these discussions. Vitrase(R) has also been studied for the treatment of diabetic retinopathy.
About ISTA
ISTA is a specialty pharmaceutical company focused on the development and commercialization of unique and uniquely improved ophthalmic products. ISTA's products and product candidates seek to address serious diseases and conditions of the eye such as dry eye, 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 http://www.istavision.com/ .
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements. Such 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. Important factors that could cause actual results to differ from current expectations include, among others, 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 for the year ended December 31, 2005.
