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Ista files with FDA for new tobramycin/prednisolone combo

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IRVINE, Calif. — A combination drug containing tobramycin and prednisolone acetate for ophthalmic use will begin phase 3 trials if the Food and Drug Administration gives its consent, according to drug developer Ista. The product will be intended for the treatment of steroid-responsive inflammatory ocular conditions where risk of bacterial infection exists, Ista said in a press release.

The tobramycin/prednisolone product, developed by Ista, is “a fixed combination of tobramycin and prednisolone acetate in a proprietary formulation that we believe will provide greater patient comfort in inflamed eyes,” said Vincente Anido Jr., PhD, Ista’s chief executive officer.

Dr. Anido noted that both active ingredients are already marketed separately. He said the company expects to begin phase 3 trials this year and to submit a new drug application to the FDA some time in the first half of 2006.

According to the press release, 2004 sales of topical ophthalmic anti-inflammatory medications in the United States totaled about $400 million.