Ista reports positive results from phase 2b study of ecabet sodium

IRVINE, Calif. — Results from a phase 2b environmental study of ecabet sodium show that the drug achieved a strong positive trend in tear film break-up time and tear production among patients with dry eye disease, according to a press release from Ista Pharmaceuticals, the developer of the drug.

The trial enrolled 144 patients who were randomly assigned to receive four daily doses of either ecabet sodium or placebo under normal environmental conditions for 43 days. Anesthetized Schirmer test results revealed a strong trend for ecabet sodium, which neared statistical significance against placebo as early as day 22 of treatment and thereafter until the completion of the trial. In addition, the investigators found that patients with more severe disease were more likely to respond to ecabet sodium than placebo.

There were no observable trends in either group in subjective symptoms as measured by the Ocular Surface Disease Index or patient's worst reported symptom. There were also no serious ocular or systemic adverse events, the release said.

"After reviewing the guidance from and our discussions with the FDA, we believe that by conducting two successful phase 3 environmental clinical trials for improvement in signs and two successful phase 3 controlled chamber clinical trials for the improvement of symptoms, we should receive marketing approval," Vicente Anido Jr., PhD, president and chief executive officer of Ista Pharmaceuticals, said in the release.

The company also expects to release results from a phase 2 clinical trial of a lower strength of Xibrom (bromfenac ophthalmic solution 0.09%) for treating the signs and symptoms of dry eye disease in the first half of 2009. Once the trial is completed, Ista will choose which dry eye products in its portfolio to accelerate into phase 3 clinical trials, which could start as early as next year, according to the release.