ISTA submits European application for eye hemorrhage injection

By Angela McDaniels

Seattle, Jan. 12 - ISTA Pharmaceuticals Inc. said the European Medicines Evaluations Agency has accepted for review the company's application for European market approval of Vitragan, known as Vitrase in the United States, for the treatment of vitreous hemorrhage.

A vitreous hemorrhage occurs when retinal blood vessels rupture and bleed into the vitreous humor, according to a company news release. These hemorrhages are caused by 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," president and chief executive officer Vicente Anido Jr. said in the release.

"Based on a recent notification from the European Medicines Evaluations Agency, we expect that the review process will most likely result in a decision by the first half of 2007."

ISTA filed its Vitragan application in the European Union during the third quarter of 2005. ISTA said the filing was based primarily upon the company's existing clinical trial data, including results from two randomized, double-blind, placebo-controlled phase 3 clinical trials.

The pooled analyses of these two studies demonstrated a statistically significant reduction in vitreous hemorrhage density and an improvement in best-corrected visual acuity, the company said. The results also demonstrated that Vitrase, which is administered via intravitreous injection, has a favorable safety profile.

ISTA's Vitrase is a proprietary formulation of highly purified ovine hyaluronidase. In May 2004, the Food and Drug Administration approved Vitrase for use as a spreading agent, for hypodermoclysis and as an adjunct in subcutaneous urography.

A New Drug Application was filed with the FDA for the treatment of vitreous hemorrhage in 2002, and ISTA said it received an approvable letter in 2003. The FDA requested additional analysis of the existing data and an additional confirmatory clinical study based upon that analysis.

ISTA is a specialty pharmaceutical company based in Irvine, Calif., that develops and commercializes ophthalmic products.

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