Mixed results for bromfenac

October 19, 2011

Top-line results from the second of two phase III studies designed to assess the safety and efficacy of bromfenac ophthalmic solution (Remura, ISTA Pharmaceuticals) in alleviating the signs and symptoms of dry eye disease correspond to the findings of the first study: bromfenac was highly effective in treating a sign (conjunctival staining) and a patient-reported

Irvine, CA-Top-line results from the second of two phase 3 studies designed to assess the safety and efficacy of bromfenac ophthalmic solution (Remura, ISTA Pharmaceuticals) in alleviating the signs and symptoms of dry eye disease correspond to the findings of the first study: bromfenac was highly effective in treating a sign (conjunctival staining) and a patient-reported symptom of dry eye, but it was not statistically significantly better than placebo.

This second study, the EAST study, amended the statistical plan to focus on a subpopulation identified as responders in the WEST study. The WEST study results showed a statistically significant improvement over placebo in the sign of conjunctival staining among female patients aged 51 to 70 years who had moderate dry eye disease. The EAST study, however, did not show a significant difference from placebo in this subpopulation.

“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,” said Timothy R. McNamara, PharmD, vice president of clinical research and medical affairs, ISTA Pharmaceuticals.

ISTA also announced plans to file in the first quarter of next year a new drug application for its investigational low concentration of bromfenac in a modified ophthalmic solution (Prolensa) developed to treat pain and inflammation associated with cataract surgery.

In two phase 3 studies, low-concentration bromfenac was statistically significantly better than placebo and met the primary efficacy endpoint of absence of ocular inflammation 14 days after surgery and the secondary efficacy endpoint of elimination of ocular pain 1 day post-surgery. No serious drug-related ocular or systemic adverse events were reported, and the new formulation’s safety profile was found to be consistent with ISTA’s currently marketed topical nonsteroidal anti-inflammatory compound (bromfenac ophthalmic solution 0.09%, Bromday).

Vicente Anido Jr., PhD, president and chief executive officer of ISTA, said the company plans to discontinue bromfenac ophthalmic solution 0.09% sometime after the successful launch of the low-concentration solution.

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