Healthcare Industry News: hyaluronidase
News Release - January 12, 2006
ISTA Pharmaceuticals Announces Acceptance of ISTA's European Marketing Application for Ovine Hyaluronidase for the Treatment of Vitreous HemorrhageIRVINE, Calif., Jan. 12 (HSMN NewsFeed) -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA ) announced today that the European Medicines Evaluations Agency (EMEA) has accepted for review ISTA's centralized Marketing Authorisation Application (MAA) seeking European market approval of Vitragan(TM) (Ovine hyaluronidase) for the treatment of vitreous hemorrhage. Vitragan is ISTA's proprietary formulation of highly purified ovine hyaluronidase which is commonly known in the U.S. as Vitrase®. A vitreous hemorrhage occurs when retinal blood vessels rupture and bleed into the vitreous humor. These hemorrhages result from leakage from abnormal, weak blood vessels and are associated with trauma, diabetic retinopathy and other factors.
"Vitreous hemorrhage is a serious and debilitating eye condition that delays the diagnosis and treatment of the underlying problem, and, if left unchecked, can lead to blindness. ISTA has accumulated a wealth of clinical data demonstrating that Vitrase can have a meaningful impact on reducing hemorrhage density and improving best-corrected visual acuity after only a single dose of treatment," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA Pharmaceuticals. Dr. Anido added, "Our development and regulatory teams have worked tirelessly to achieve this major milestone for the Company and their efforts have resulted in EMEA acceptance of this marketing application. Based on a recent notification from the EMEA, we expect that the review process will most likely result in a decision by the first half of 2007."
ISTA filed its Vitragan MAA in the EU during the third quarter of 2005. The filing was based primarily upon the Company's existing clinical trial data, including results from two randomized, double-masked, placebo-controlled international Phase III clinical trials. The pooled analyses of these two studies demonstrated a statistically significant reduction in vitreous hemorrhage (VH) density as early as one month that persisted through three months following a single intravitreous injection of Vitrase® when compared to a single injection of saline solution. 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. The results also demonstrated that Vitrase has a favorable safety profile, and no serious safety issues were reported following a single intravitreous injection of Vitrase.
In addition to a reduction in VH density, the results of the Phase III trials demonstrated that patients receiving a single intravitreous injection of Vitrase showed improvement in best-corrected visual acuity (BCVA) of three or more lines on an eye chart as early as one month and through three months when compared to a single injection of saline solution. Furthermore, there was a decrease in the density of the vitreous hemorrhage that was clinically meaningful and statistically significant as compared to placebo as early as one month and through three months following a single intravitreous injection of a 55 IU (68 USP Unit) dose of Vitrase.
ISTA's Vitrase® is a proprietary formulation of highly purified ovine hyaluronidase. In May 2004, the U.S. Food & Drug Administration (FDA) approved in the U.S. Vitrase® 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 the U.S. 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 by FDA for use as a spreading agent, for hypodermoclysis and as an adjunct in subcutaneous urography, Vitrase® has been studied for the treatment of vitreous hemorrhage. A New Drug Application (NDA) was filed 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. Vitrase ® has also been studied for the treatment of diabetic retinopathy.
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 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. For example and without limiting the foregoing, the statement regarding the timing of any EMEA decision regarding the Vitragan MAA is a forward-looking statement. 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: risks and uncertainties related to ISTA's research and development programs (including the difficulty of predicting the timing or outcome of product development efforts and EMEA or other regulatory agency approval or actions); and, such other 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 quarters ended March 31, 2005, June 30, 2005 and September 30, 2005.
Source: ISTA Pharmaceuticals
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