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Vitrase (Hyaluronidase Injection) Now Available to US Ophthalmologists

IRVINE, CA -- January 6, 2005 -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA) today announced ISTA's United States market launch of Vitrase® (hyaluronidase injection) ovine in a 200 USP Units/mL vial in sterile solution and Vitrase (hyaluronidase for injection) lyophilized, ovine in a 6200 USP Units multi-purpose vial, both for use as a spreading agent to facilitate the absorption and dispersion of other injected drugs, for hypodermoclysis and as an adjunct in subcuteanous urography. 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, "The launch of two vial sizes of Vitrase will provide ophthalmologists and other physicians with the flexibility they require in their practice. To support our Vitrase launch, we plan on converting the Ventiv Pharma Services sales representatives that are currently promoting Istalol™ to ISTA employees but we will continue our relationship with Ventiv Pharma Services for sales force administration and other services. In addition, we plan to expand our sales force from 28 representatives to 50 during the first quarter of 2005 to allow us to extend our reach to over 7000 ophthalmologists in the U.S."

The Vitrase launch is ISTA's second new product launch within the past six months. Istalol, a once-a-day formulation of timolol for the treatment of glaucoma, was launched in July 2004. First shipments of Vitrase to physicians, hospitals, ambulatory surgery centers, and wholesalers will begin within the next few weeks. For additional information concerning the availability of Vitrase, please call 1-877-4Vitrase, or 1-877-484-8727, or send an e-mail to Vitrase@istavision.com.

ABOUT VITRASE®
ISTA's Vitrase is a proprietary formulation of highly purified ovine hyaluronidase. In May 2004, the FDA approved Vitrase in a lyophilized 6200 USP Units multi-purpose vial for use as a spreading agent; a 200 USP Units/mL vial in sterile solution for use as a spreading agent was approved in December 2004.

FDA's approval of Vitrase for use as a spreading agent in May 2004 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.

In addition to its approval for use as a spreading agent, for hypodermoclysis and as an adjunct in subcuteanous urography, Vitrase has been studied for the treatment of vitreous hemorrhage. A New Drug Application, or 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.

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