Results: Bromfenac same as placebo

August 10, 2011

Initial top-line results from a Phase III study of bromfenac ophthalmic solution (Remura, ISTA Pharmaceuticals) indicate that bromfenac was not statistically superior to placebo in treating one sign and one symptom of dry eye disease. ISTA announced this result from the WEST study, the first of two phase III safety and efficacy studies being conducted under a special protocol assessment (SPA) agreed upon with the FDA.

Irvine, CA-Initial top-line results from a phase III study of bromfenac ophthalmic solution (Remura, ISTA Pharmaceuticals) indicate that bromfenac was not statistically superior to placebo in treating one sign and one symptom of dry eye disease.

ISTA announced this result from the WEST study, the first of two phase III safety and efficacy studies being conducted under a special protocol assessment (SPA) agreed upon with the FDA.

According to preliminary analysis of the top-line results from the WEST study, while bromfenac was highly effective in treating a sign (conjunctival staining) and a patient-reported symptom of dry eye, it was not statistically significantly better than placebo. Two concentrations of bromfenac were tested, and both concentrations showed highly statistically significant improvement (p < 0.0001) compared with baseline in conjunctival staining and one symptom, as did placebo. The co-primary endpoints identified in the SPA, however, require bromfenac to achieve a statistically significant difference from placebo, not baseline.

“Since [bromfenac] did not meet its co-primary end-points in the WEST study, armed with [these] data, we expect to amend the statistical plan to focus the EAST study appropriately,” said Timothy R. McNamara, PharmD, vice president of clinical research and medical affairs, 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 we'll make decisions about future development plans.”

ISTA is testing two concentrations of bromfenac in two separate studies, known as EAST and WEST, conducted under a common protocol. Together, the studies are designed to enroll a total of about 1,000 patients with mild or moderate dry eye disease, randomly assigned on a 1:1:1 basis to receive one of the two bromfenac dose levels, or placebo, in both eyes, twice daily, for 42 days. The sign of conjunctival staining is being measured using the lissamine green staining test, while the subjective symptoms are being measured using the Ocular Surface Disease Index, a 12-question survey used by patients to document symptoms. The WEST study enrolled a total of 420 patients, 140 in each of the three arms. ISTA expects to announce top-line results from the EAST study during fourth quarter of 2011.

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