April 23, 2004
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Ista reduces net loss in first quarter

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IRVINE, Calif. — Ista Pharmaceuticals decreased its net loss in the first quarter of 2004 compared to the same period a year ago, the company announced in a press release. Its net loss of $5.2 million in the quarter equated to $0.30 per share, compared to $5.3 million or $0.40 per share in the first quarter of 2003.

Revenue generated during the period is attributable to the license fee payment from Otsuka Pharmaceutical Co. in connection with a license for Vitrase (ovine hyaluronidase) in Japan, according to a press release from Ista.

Vitrase is being developed for the treatment of vitreous hemorrhage, for use as a spreading agent and for diabetic retinopathy. In the United States, Vitrase has been issued an approvable letter for the treatment of vitreous hemorrhage, and a separate formulation is undergoing review for use as a spreading agent, the company said.

Istalol (timolol) received an approvable letter from the Food and Drug Administration last year, and an amended application in December sought to qualify Bausch & Lomb as an alternative manufacturer. The Ista press release said final regulatory approval is expected during the second quarter of 2004.

Xibrom (bromfenac) is a topical nonsteroidal anti-inflammatory compound for the treatment of ocular inflammation, also manufactured by Ista. Phase 3 studies have been completed and results were announced last month. The company expects to submit a New Drug Application for Xibrom during the second quarter.

Caprogel (aminocaproic acid) is a topical gel formulation of the drug for the treatment of hyphema. The drug is undergoing feasibility studies.