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Phase III Data Presented for Vitrase in the Treatment of Vitreous Hemorrhage
The integrated results demonstrated a statistically significant reduction in vitreous hemorrhage density as early as one month and through three months following a single intravitreous injection of Vitrase when compared to a single injection of saline solution. This reduction allows the investigator to see into the back of the eye and diagnose the underlying cause of the hemorrhage. These clinical results were previously submitted to the U.S. Food & Drug Administration as part of the Company's New Drug Application (NDA) for Vitrase for vitreous hemorrhage and were announced last year.
ISTA's Vitrase is a proprietary formulation of highly purified ovine hyaluronidase, which has been studied for administration by injection into the vitreous of the eye.
On August 5th, 2003, ISTA submitted a second NDA seeking approval for use of Vitrase as a spreading agent to facilitate the dispersion and absorption of other drugs. In addition, in the Dosage and Administration section of the NDA, the Company is seeking approval from the FDA to provide directions for reconstitution of Vitrase for potential treatment applications in the back of the eye.
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 become a fully integrated specialty pharmaceutical company by acquiring complementary products, either already marketed or in late-stage development.
Source: ISTA Pharmaceuticals, Inc.