ISTA Pharmaceuticals Files IND for Phase IIb Trial of Ecabet Sodium
ISTA Pharmaceuticals has submitted an investigational new drug application (IND) with the FDA to conduct a Phase IIb clinical trial for ecabet sodium, a prescription eye drop for the treatment of dry eye syndrome (keratoconjunctivitis sicca).
Pending clearance by the FDA, ISTA intends to initiate the Phase IIb trial in the second quarter of 2005. ISTA's ecabet sodium Phase IIb trial is designed to evaluate several ocular signs and symptoms, the results of which will be used to define the efficacy endpoints for the Phase III trial.
Ocular signs that will be evaluated during the Phase IIb trial include but are not limited to corneal and conjunctival staining and tear film break-up time. Ocular symptoms that will be evaluated during the Phase IIb trial include, but are not limited to, burning or stinging, itchiness or scratchiness, grittiness or sandiness, foreign body sensation, haziness, or blurriness. Generally, improvement in one sign and one symptom are considered acceptable by the FDA for approval of a prescription dry eye product.