This is the latest on Ista Pharmaceutical's Phase IIb clinical trials of ecabet sodium as a dry eye treatment. Positive trends were noted in blink rate, OSDI scores and subjective assessment of patients' most bothersome symptom.
Ista anticipate starting Phase III clinical trials next year.
A total of 112 patients were assigned randomly to receive either ecabet sodium or placebo four times a day for 90 days. There were four primary efficacy endpoints: two objective signs (blink rate and corneal staining) and two subjective symptoms (the patient's most bothersome symptom and the patient's response to the Ocular Surface Disease Index (OSDI)). Patients were evaluated in a controlled adverse environment ("dry eye chamber") twice during the study, once on Day 1 and once on Day 91. The objective signs were measured pre- and post-exposure to the dry eye chamber on Day 91. The subjective symptoms were measured following exposure to the dry eye
chamber on both Day 1 and Day 91. To date, the FDA has considered improvement, as measured in Phase III studies, in one sign and one symptom to be acceptable for approval of a prescription dry eye product.