ISTA Pharmaceuticals plans phase III study of ecabet sodium for dry eye

Irvine, CA-ISTA Pharmaceuticals Inc. has announced tentative plans to begin a phase III clinical study of ecabet sodium for dry eye syndrome in 2008. The news follows the receipt of positive results from a preliminary analysis of the company’s phase IIb study of the drug.

In the phase IIb study, 112 patients were assigned randomly to receive either ecabet or placebo four times a day for 90 days. The four primary efficacy endpoints included two objective signs (blink rate and corneal staining) and two subjective symptoms (most bothersome symptom and the patient score on 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 before and after exposure to the chamber on day 91. The subjective symptoms were measured following exposure to the chamber on day 1 and day 91.

Investigators found a strong trend in the blink rate of the ecabet group. Also, the ecabet group demonstrated a strong trend on the OSDI and a positive trend in the subjective assessment of most bothersome symptom.

Although the phase IIb study was not powered to show statistical significance, ecabet achieved statistical significance in the OSDI assessment. No serious ocular adverse events were reported compared with placebo. Further analyses of the phase IIb study results are ongoing.

“Ecabet sodium may provide advantages over other dry eye products and product candidates, as we believe the drug not only improves the quality of tears by enhancing mucin production, but may increase the quantity of tears produced,” said Vicente Anido Jr., PhD, president and chief executive officer of ISTA. “Although not a predetermined endpoint in this study, 14% of patients in the treatment group reported increases in the quantity of tears produced, compared [with] only 1.8% in the placebo group.”

Dr. Anido said that the company will request a meeting with the FDA to determine how to bring the drug to market, after it completes analysis of phase II study results.