ISTA announces results of phase IIb study of ecabet

Irvine, CA

-Patients treated with ecabet sodium demonstrated a strong positive trend in the objective sign of tear film break-up time and a positive trend in the objective sign of quantity of tears produced (Schirmer’s test) in a phase IIb study conducted by ISTA Pharmaceuticals, according to the company, which is developing the drug as a treatment for dry eye disease.

No trends for either objective sign were seen in the placebo group, according to the company, and no trends were seen in either group in subjective symptoms as measured by the Ocular Surface Disease Index (OSDI) or patient’s worst reported symptom.

“The phase IIb results from this environmental study add further support to our belief that ecabet sodium has the ability to treat signs and symptoms of dry eye syndrome,” said Vicente Anido Jr., PhD, president and chief executive officer of ISTA Pharmaceuticals.

Dr. Anido said that the company expects to receive market approval for the drug “by conducting two successful phase III environmental clinical trials for improvement in signs and two successful phase III controlled chamber clinical trials for the improvement of symptoms.”

The company also expects results from a phase II clinical trial studying the potential of a lower strength of bromfenac (Xibrom) to treat the signs and symptoms of dry eye disease in the first half of this year. “Once this . . . trial is completed, we will make a decision on which product or products in our dry eye franchise to move into phase III trials, which could start as early as 2010,” Dr. Anido said.

ISTA’s previous two phase II trials of ecabet, which were conducted in a controlled environment chamber, demonstrated positive trends in patient symptoms (OSDI and patient’s worst symptom, both trials) and in the signs of corneal staining (one trial) and blink rate (both trials), according to a statement from the company. The company said that it is not concerned about the lack of response to ecabet in symptoms in the most recent trial, “in part because the OSDI responses to ecabet were strong and predictable in the previous phase II trials.”

“Given the ability to demonstrate a positive effect on signs in the environment and on symptoms in the controlled environment chamber, there is now a clear path forward to phase III studies and new drug application filing for this product,” the statement said.