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Phase III Trial Results Demonstrate Bromfenac Effective in Ocular Inflammation
In two double-masked, placebo-controlled U.S. Phase III studies conducted under a single protocol, a statistically significant proportion of patients treated with Xibrom achieved treatment success as compared to placebo. Treatment success was defined as the complete absence of ocular inflammation. In one study involving 296 patients at 20 study sites, more Xibrom-treated patients cleared their ocular inflammation at 15 days when compared to patients receiving placebo at a rate of 62.6 % versus 39.8%, respectively. In a second U.S. study, which involved 231 patients at 19 study sites, the rates of ocular inflammation clearance at the primary endpoint of 15 days were 65.8% for Xibrom-treated patients and 47.9% for patients receiving placebo. Statistical significance in each trial reached a p value of less than 0.01. The company's analyses showed that Xibrom's treatment effect was evident as early as day three in both trials. The primary endpoint for both studies was the proportion of patients with complete absence of ocular inflammation, as measured by an assessment of immune cells in the anterior chamber of the eye (cells) and cellular debris ("flare").
For each trial, the secondary efficacy analysis of inflammation clearance in patients only on assigned treatment (with no other medications administered) also showed a statistically significant benefit for Xibrom treatment at 15 days versus placebo. In the 20-site study, the rates of clearance were 57.6% for Xibrom and 23.5 % for placebo. In the 19-site study, the rates of clearance were 62.0 % for Xibrom and 31.5 % for placebo. Both studies, when analyzed separately, also showed that Xibrom was well tolerated with a very low incidence of ocular adverse events. The efficacy and safety findings were consistent with results of previous studies conducted in Japan by Senju Pharmaceuticals Co. Ltd.
Based upon the results of the two trials, ISTA plans to file a New Drug Application (NDA) for Xibrom with the U.S. Food & Drug Administration in the second quarter of 2004.
"We are very pleased with our Phase III results for each of the two trials, for which our initial analysis has shown that Xibrom dosed twice daily results in statistically significant efficacy with a low incidence of ocular irritation," stated Vicente Anido, Jr., Ph.D., ISTA's Chief Executive Officer. "Xibrom's twice-daily dosing should make it more convenient than and an important therapeutic advance over other non-steroidal anti-inflammatory drugs which are usually administered four times a day."
Dr. Anido added, "Based upon our current schedule for the NDA filing and assuming timely FDA review and approval, ISTA's marketing team could launch Xibrom in the United States in the first half of 2005."
About the Clinical Trials
A total of 527 patients were enrolled in two randomized, double- masked, placebo-controlled studies under the same protocol at 39 sites in the U.S. Under the trial protocols patients who had undergone cataract surgery in one eye and baseline inflammation post surgery were randomly assigned to either Xibrom or placebo twice daily for 14 days. At entry to the studies, each patient's summed ocular inflammation score was at least grade three on a five point scale. Efficacy was assessed on Day 15 and was defined as complete absence of ocular inflammation. The secondary endpoint measured clearance of ocular inflammation in patients at day 15 for patients who only received the assigned treatment (with no other medications administered).
Xibrom is a topical non-steroidal anti-inflammatory compound for the treatment of ocular inflammation. Xibrom was launched in Japan in 2000 by Senju Pharmaceuticals Co. Ltd. ISTA acquired U.S. marketing rights for Xibrom in May 2002.
Source: Ista Pharmaceuticals