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FDA Approves New, Smaller Vial Size for Vitrase (Hyaluronidase Injection) IRVINE, CA -- December 3, 2004 -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA) today announced that the U.S. Food & Drug Administration (FDA) has approved a single-use vial of Vitrase® (hyaluronidase injection) Ovine sterile solution for use as a spreading agent to facilitate the dispersion and absorption of other drugs. ISTA's Vitrase is a proprietary formulation of highly purified, preservative-free ovine hyaluronidase, which has been studied extensively in several ophthalmic conditions. Vicente Anido, Jr., Ph.D., ISTA's Chief Executive Officer, stated, "We are pleased with the current approval and anticipate that we will launch the new vial size, as well as the previously approved 6,200 USP Units multi-purpose vial, early in the first quarter of 2005. We believe the smaller-sized vial will greatly enhance the convenience of using Vitrase as a spreading agent by ophthalmologists. Further, the availability of Vitrase provides ophthalmologists with a preservative-free alternative to other available hyaluronidases, including non-FDA approved hyaluronidases sold by compounding pharmacies." In May 2004, the FDA approved Vitrase in a 6,200 USP Units multi-purpose vial, for use as a spreading agent to facilitate the absorption and dispersion of other drugs. This approval removed hyaluronidase from the FDA's drug shortage list where it had been listed since 2001. According to the American Academy of Ophthalmology, prior to 2001, a hyaluronidase spreading agent was used in conjunction with other drugs in over 750,000 ophthalmic surgeries in the United States. About Vitrase® 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. According to the approved labeling "Hyaluronidase is a spreading or diffusing substance, which modifies the permeability of connective tissue through the hydrolysis of hyaluronic acid, a polysaccharide found in the intercellular ground substance of connective tissue, and of certain specialized tissues, such as the umbilical cord and vitreous humor." Further: "Hyaluronidase hydrolyzes hyaluronic acid by splitting the glucosaminidic bond between C1 of the glucosamine moiety and C4 of glucuronic acid. This temporarily decreases the viscosity of the cellular cement and promotes diffusion of injected fluids or of localized transudates or exudates, thus facilitating their absorption." In addition to its approval for use as a spreading agent, Vitrase has been studied for the treatment of vitreous hemorrhage. An 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 has also been studied for the treatment of diabetic retinopathy. SOURCE: ISTA Pharmaceuticals, Inc. E-mail this page to a friend or colleague! To print, use this version