The US FDA has approved a single-use vial of ISTA Pharmaceuticals' 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, the company announced here.

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.

Vicente Anido, Jr, ISTA's CEO, 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."

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. In addition to its approval for use as a spreading agent, Vitrase has been studied for the treatment of vitreous haemorrhage. An NDA was filed for the treatment of vitreous haemorrhage in 2002 and an approvable letter for that NDA was received in 2003.