The preliminary results of the study demonstrated a strong trend in efficacy for the lower (3%) dose with respect to ecabet sodium’s ability to address two objective signs of dry eye syndrome, corneal staining and blink rate.
In addition, patients treated with the lower dose of ecabet sodium reported positive trends for reductions in symptomatology as measured by ocular surface disease index.
However, in the preliminary results, no efficacy trends versus placebo were observed with respect to the higher (3.9%) dose. Further analyses of the phase IIb results are ongoing, the company said.
A total of 162 patients were enrolled in the trial and were randomly assigned to receive placebo, 3% or 3.9% ecabet sodium in the study eye four times a day for 90 days.
The company estimates that sales in the US prescription dry eye market were approximately $200 million in 2005 and are anticipated to grow to approximately $350 to $700 million in annual sales within three to five years.
“We are very encouraged by the preliminary findings, which show that ecabet sodium may be effective in addressing signs and symptoms of dry eye syndrome, a painful and debilitating eye disorder. The positive trends in symptomatology that were observed in our phase IIb trial appear better than the results we have seen in other drugs studied for this syndrome,” said Dr Vicente Anido, Jr., president and CEO of Ista.