According to the company, patients treated with ecabet sodium achieved 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. In contrast, there were no trends seen in the placebo group for either objective sign.
In addition, there were no trends seen in either group in subjective symptoms as measured by the ocular surface disease index or patient’s worst reported symptom. In Phase II tests where observations are not powered to show statistical significance, strong and positive trends are used as indicators of potential efficacy in subsequent Phase III studies, the company said.
Vicente Anido, Jr, president and CEO of Ista Pharmaceuticals, said: After reviewing the guidance from and our discussions with the FDA, we believe that 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, we should receive marketing approval.
In addition, we are expecting results from a Phase II clinical trial studying the potential of a lower strength of Xibrom to treat the signs and symptoms of dry eye disease in the first half of 2009. Once this lower strength Xibrom 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.