The US FDA has granted three years of market exclusivity for ISTA Pharmaceuticals' Vitrase (hyaluronidase for injection; lyophilized, ovine), 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 ovine hyaluronidase. 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 injected drugs. In August 2004, ISTA filed a supplemental New Drug Application (sNDA) for a smaller, single-use, 150 USP Units/mL vial of Vitrase that the Company believes it will be more convenient and cost effective for use as a spreading agent. Pending FDA review and approval, ISTA plans to launch this new vial size in early 2005, a release from ISTA said.

Vicente Anido, Jr., president and CEO of ISTA stated, "The approval of Vitrase earlier this year allowed for the reintroduction of a drug to the market that had previously been listed on the FDA's Drug Shortages list. To date, we have made the product available to physicians free of charge. Once we have approval for the 150 USP units/mL vial, a smaller and more convenient configuration, we'll start full-scale commercialization efforts. We expect approval of the smaller Vitrase vial later this year."

ISTA's US market exclusivity extends until May 5, 2007; prior to this date, the FDA can not approve any other hyaluronidase in the United States for this indication, the release added.

ISTA is a specialty pharmaceutical company focused on the development and commercialization of ophthalmic products. ISTA's products seek to address serious diseases and conditions of the eye such as vitreous haemorrhage, diabetic retinopathy, hyphema, glaucoma, ocular pain and inflammation.