Post-cataract inflammation drug fares well in phase 3 trials

IRVINE, Calif. — A new anti-inflammatory drug is showing efficacy in clinical trials, according to the drug’s maker.

Positive, statistically significant results from a phase 3 trial of Xibrom (0.1% bromfenac sodium ophthalmic solution) a topical nonsteroidal anti-inflammatory drug for treatment of ocular inflammation following cataract surgery, were released earlier this week by developer Ista Pharmaceuticals.

Xibrom underwent two double-masked, placebo-controlled phase 3 trials. Success in the trial was defined as the complete absence of ocular inflammation.

The first clinical trial involved 296 patients at 20 study sites; 62.6% of the Xibrom-treated patients cleared their ocular inflammation at 15 days, compared to 39.8% of patients on placebo. A second trial involved 231 patients at 19 study sites. At 15-day follow-up, 65.8% of Xibrom-treated patients were cleared of ocular inflammation, compared to 47.9% of patients on placebo.

According to an Ista press release, Xibrom’s treatment effect was evident as early as day 3 in both trials.

Ocular inflammation was measured by cell and flare in the anterior chamber. Ista noted its efficacy and safety findings were consistent with results from previous trials conducted by Senju Pharmaceuticals in Japan. According to the release, Ista plans to file a new drug application with the Food and Drug Administration in the second quarter of this year, with an anticipated U.S. launch some time in 2005.