Executives blamed a “dramatic” placebo response
Jeepers creepers, if that ain't a lesson in attempting to spin the unspinnable. Sigh. Let's hope the EAST study (see below) fares better.
ISTA Pharmaceuticals Reports Results From the First of Two Trials in the REMURA(TM) Phase 3 Clinical Program for Dry Eye Disease
IRVINE, CA, Jul 28, 2011 (MARKETWIRE via COMTEX) -- ISTA Pharmaceuticals, Inc. ISTA +11.29% , today announced top-line results from the first 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. The company's Phase 3 safety and efficacy program, which consists of two studies known as EAST and WEST, is being conducted under a Special Protocol Assessment (SPA) agreed upon with the U.S. Food and Drug Administration (FDA). Today's top-line results are from the WEST study; the EAST study is now fully enrolled and the Company expects to announce top-line results from the EAST study during fourth quarter of 2011.
According to preliminary analysis of the top-line results from the WEST study, while REMURA was highly effective in treating a sign and symptom of dry eye, it was not statistically significantly better than placebo, a common outcome reported in studies testing other dry eye therapies. From baseline, both concentrations of REMURA and the placebo showed highly statistically significant improvement (p < 0.0001) in one sign and one symptom. The co-primary end-points identified in the SPA require REMURA to achieve a statistically significant difference from placebo, not baseline, which was not achieved in the WEST Study.
In analyzing the patient data, the higher concentration of REMURA achieved statistical significance against placebo in the sign of conjunctival staining as measured using the Lissamine Green (LG) Staining test among a sub-population of female patients 51-70 years of age with moderate dry eye disease. 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.
"Consistent with our Phase 2 Study data, today's results show REMURA has a significant impact on the signs and symptoms of dry eye when compared to baseline. Since REMURA did not meet its co-primary end points in the WEST study, armed with this data, we expect to amend the statistical plan to appropriately focus the EAST study," stated Timothy R. McNamara, Pharm.D., Vice President of Clinical Research and Medical Affairs of ISTA Pharmaceuticals. "The EAST study is now fully enrolled, but the database has not been locked. We continue to analyze the WEST data, and once we see the data from the EAST Study, which we plan to announce in the fourth quarter, we'll make decisions about future development plans."