ISTA's combination ophthalmic product yields positive phase 3 results

By Lisa Kerner

Erie, Pa., Feb. 2 - ISTA Pharmaceuticals, Inc. announced positive results from a phase 3 bioequivalence study of its proprietary investigational combination ophthalmic product. The combination product contains tobramycin and prednisolone acetate for the treatment of steroid-responsive inflammatory ocular conditions where risk of bacterial infection exists.

Prednisolone acetate is a commonly prescribed anti-inflammatory agent, while tobramycin is a commonly prescribed aminoglycoside antibiotic solution, according to a company news release.

A total of 132 patients undergoing bilateral cataract surgery were enrolled in the multi-center, randomized, double-masked U.S. phase 3 trial.

Patients were randomly assigned to receive either ISTA's combination product or prednisolone acetate 1% in each eye. Of these 132 patients, 124 had a viable aqueous humor sample taken from each eye at the time of surgery at either 30, 60, 90, 120, 180 or 240 minutes following administration of the test agent.

The trial successfully achieved its primary endpoint, demonstrating bioequivalence of prednisolone between ISTA's combination product (tobramycin 0.3%/prednisolone acetate 1.0%) and prednisolone acetate 1.0%, the company said.

The trial's secondary endpoints were also achieved, demonstrating that ISTA's proprietary combination product and prednisolone acetate 1% had similar maximum concentrations, and the time to reach maximum concentration was identical for both.

ISTA's combination product demonstrated a favorable safety profile, and no treatment-related adverse events were reported, the company said.

"We are pleased with the pharmacokinetic data from our phase 3 study indicating bioequivalence in both the intent-to-treat and per protocol populations," ISTA president and chief executive officer Vicente Anido Jr. said in the release.

Based on the phase 3 study results, ISTA said it plans to submit a New Drug Application to the Food and Drug Administration in the first half of 2006.

ISTA, an Irvine, Calif.-based specialty pharmaceutical company, develops and commercializes ophthalmic products.

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