Vitrase

Findings Presented in Poster Session during 109th American Academy of Ophthalmology Annual Meeting in Chicago, Illinois

IRVINE, Calif., Oct. 20 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. today announced the presentation of data from a pooled, subset analysis of the Company's two randomized, double-masked, placebo- controlled Phase III studies of Vitrase(R) (Ovine Hyaluronidase) for the management of vitreous hemorrhage, a serious condition affecting the back of the eye for which there is currently no drug treatment. The data were presented in a scientific poster session entitled, "Three Line Improvement in BCVA Using Vitrase in Subjects with Vitreous Hemorrhage Not Related to AMD," during the 109th Annual Meeting of the American Academy of Ophthalmology, currently being held in Chicago, Ill.

The subset analysis considered results in patients suffering from severely decreased visual acuity associated with non-clearing vitreous hemorrhage (VH) not due to age-related macular degeneration (AMD). According to the analysis, a single intravitreous injection of 55 IU Vitrase resulted in statistically greater improvement in best-corrected visual acuity (BCVA) of three or more lines on an eye chart when compared to a single injection of saline solution (p = .002).

"The wealth of positive 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 patients with non-clearing VH not due to AMD," stated Lisa R. Grillone, Ph.D., Vice President of Clinical Research and Medical Affairs at ISTA Pharmaceuticals. "We believe that the results from our clinical trials for Vitrase demonstrate the potential clinical usefulness of this drug, particularly in patients without AMD."

About the Clinical Trials

A total of 1,306 patients were enrolled in two randomized, double-masked, placebo-controlled international 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; a 200 USP Units/mL vial in sterile solution for use as a spreading agent was approved in December 2004. FDA's approval of Vitrase 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 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. A New Drug Application, or NDA, was filed 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. 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 more information, please visit the company's Web site 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. ISTA disclaims any intent or obligation to update any 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, 2004 and ISTA's Quarterly Reports on Form 10-Q for the periods ended March 31, 2005 and June 30, 2005.

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 Media: Justin Jackson, jjackson@burnsmc.com or Jason Farber, jfarber@burnsmc.com, or Investors: Lisa Burns, or Laura Siino, lsiino@burnsmc.com, +1-212-213-0006, all of Burns McClellan for ISTA Pharmaceuticals

Web site: http://www.istavision.com/

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