ISTA Pharmaceuticals Reports Results From the Second of Two Studies in the REMURA(TM) Phase 3 Clinical Program for Dry Eye Disease
IRVINE, CA, Oct 13, 2011 (MARKETWIRE via COMTEX) -- ISTA Pharmaceuticals, Inc. ISTA -1.96% today announced top-line results from the second of its two Phase 3 studies to evaluate the short-term safety and efficacy of two concentrations of REMURA(TM) (bromfenac ophthalmic solution for dry eye) in alleviating the signs and symptoms of dry eye disease. In the EAST study, REMURA was highly effective in treating a sign and symptom of dry eye but was not statistically significantly better than placebo in the entire patient cohort, a common outcome reported in studies testing other dry eye therapies. In both Phase 3 studies, safety data demonstrated REMURA was well-tolerated, with an adverse event profile similar to placebo and consistent with those observed previously with REMURA in a Phase 2 study and with other prescription dry eye drops. All three formulations were rated by patients as very comfortable.
"For the EAST study, we amended the statistical plan to focus on the subpopulation identified in the WEST study as responders. In the previously announced WEST study, the results showed a statistically significant improvement over placebo in the sign of conjunctival staining, as measured using the Lissamine Green (LG) Staining test, among female patients 51-70 years of age with moderate dry eye disease. However, the EAST study did not show a significant difference from placebo in this subpopulation, which we believe is partly due to the fact that the EAST study enrolled far fewer patients with mild to moderate dry eye disease," stated Timothy R. McNamara, Pharm.D., Vice President of Clinical Research and Medical Affairs of ISTA Pharmaceuticals. "We will complete a full analysis of the data, but focus our efforts on the potential use of the vehicle as an over-the-counter artificial tear product."