Ista announces positive preliminary results from phase 2b dry eye drug study

IRVINE, Calif. — Preliminary results of a phase 2b clinical study of ecabet sodium show that the drug can improve signs and symptoms of dry eye syndrome, according to a press release from Ista Pharmaceuticals, the drug's developer.

The study enrolled 112 patients who were randomly assigned to receive either ecabet sodium or placebo four times daily for 90 days. Investigators found that patients treated with the drug had a strong trend in the objective sign of blink rate. These patients also reported a strong trend in the Ocular Symptom Disease Index (OSDI) and a positive trend in the subjective assessment of their most bothersome symptom.

There were no reports of serious ocular adverse events compared with placebo. Further analyses of the study results are ongoing, according to the release.

Although the phase 2b study was not powered to show statistical significance, ecabet sodium achieved statistical significance in the OSDI assessment, the release said.

Also, "Although not a predetermined endpoint in this study, 14% of patients in the treatment group reported increases in the quantity of tears produced, as compared to only 1.8% in the placebo group," said Vicente Anido Jr., PhD, Ista's president and CEO, in the release.

"We are continuing our analyses of both of our phase 2 clinical studies to identify the signs and symptoms to evaluate in phase 3 testing. Upon completion of the analyses, we will request a meeting with the Food and Drug Administration to discuss its recommended clinical path," he said, noting that company officials anticipate beginning phase 3 studies in 2008.