ISTA Pharmaceuticals, Inc, announced positive results from the company's phase-IIb clinical study of ecabet sodium, which is being developed as a treatment for dry eye disease. Patients treated with ecabet sodium achieved a strong positive trend in the objective sign of Tear Film Break-Up Time (TFBUT) and a positive trend in the objective sign of quantity of tears produced (Schirmer Test). 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 (OSDI) 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 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. Ecabet sodium may provide advantages over other products used to treat dry eye and those that are in development, as we believe ecabet sodium not only improves the quality of tears but also increases the quantity of tears," stated Vicente Anido president and chief executive officer of ISTA Pharmaceuticals. "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."
ISTA's previous two phase-II trials of ecabet, which were conducted in a controlled environment chamber, demonstrated positive trends in patient's symptoms (OSDI and patient's worst symptom, both trials) and in the signs of corneal staining (one trial) and blink rate (both trials). The company believes the lack of response to ecabet in symptoms in the most recent trial is not of concern, in part because the OSDI responses to ecabet sodium were strong and predictable in the previous phase-II trials. ISTA believes that 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.
ISTA acquired US rights to ecabet sodium for the treatment of dry eye syndrome from Senju Pharmaceuticals Co, Ltd, in November of 2004.
ISTA Pharmaceuticals is an ophthalmic pharmaceutical company. ISTA's products and product candidates addressing the $4.7 billion US prescription ophthalmic industry include therapies for inflammation, ocular pain, glaucoma, allergy, and dry eye.