ISTA Pharmaceuticals Inc announced that the US Food and Drug Administration has approved ISTA's New Drug Application (NDA) for Vitrase (hyaluronidase for injection; lyophilized, ovine) for use as a spreading agent to facilitate the dispersion and absorption of other drugs. This approval removes hyaluronidase from the FDA's drug shortage list where it has been listed since 2001. ISTA's Vitrase is a proprietary formulation of highly purified, preservative-free ovine hyaluronidase, which has been studied extensively in several ophthalmic conditions.

H. Dunbar Hoskins, Jr., MD, executive vice president of the American Academy of Ophthalmology (AAO), commented, "The Academy of Ophthalmology is pleased that ISTA Pharmaceuticals has made this drug available after a long absence from the market. Many ophthalmologists will find Vitrase to be highly useful in their surgical procedures." Prior to 2001, a bovine-derived, thimerosal-preserved form of hyaluronidase was reportedly used as a spreading agent in conjunction with other drugs in over 750,000 ophthalmic surgeries.

The Indications and Use section of the newly approved labeling state that "Vitrase is indicated as an adjuvant to increase the absorption and dispersion of other injected drugs; for hypodermoclysis; and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents." In addition, the Dosage and Administration section provides directions for reconstitution of Vitrase in five different dose concentrations facilitating its use for different conditions from a single vial of 6200 Units.

Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA stated, "We are thrilled by the ophthalmic community's and FDA's commitment to bringing this product forward and we will immediately initiate pre- commercialization activities, including scaling up manufacturing and addressing the reimbursement issues. We also plan to file in the near future a supplemental NDA for a smaller vial size at a dose concentration (150 Units/mL) that we believe is optimal for use as a spreading agent. We anticipate that, pending timely submission of our NDA supplement and FDA review, this new vial size could be approved by the FDA during the second half of 2004."