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Once-daily bromfenac fails to reach significance in endpoints in one arm of trial program
IRVINE, Calif. — Two phase 3 clinical trials of once-daily formulations of bromfenac sodium ophthalmic solution have found that the drug showed efficacy for eliminating ocular inflammation 15 days after cataract surgery and for eliminating ocular pain at 1 day postop.
However, both primary and secondary endpoints did not achieve statistical significance in one arm of the clinical program, according to a press release from Ista Pharmaceuticals, the developer of the drug.
The two identical, multicenter, randomized, double-masked, parallel-group, vehicle-controlled studies evaluated the 0.09% formulation of Xibrom (bromfenac sodium ophthalmic solution) dosed once-daily against placebo. The studies were performed under a common protocol and were designated as the East region trial and the West region trial.
When considered independently, the West region trial achieved statistical significance for both the primary endpoint of eliminating ocular inflammation at 15 days postop and the secondary efficacy endpoint of eliminating ocular pain at 1 day postop. However, the East region trial failed to meet statistical significance for either, the release said.
In the East region trial, six times more patients discontinued participation due to lack of efficacy than in the West region trial. In addition, there was a 20 percentage point higher placebo effect for the relief of pain in the East region trial compared with both West region results and previous trial results.
Both studies showed statistically significant results in the proportion of patients with no photophobia at every postoperative visit. There were no serious ocular or systemic adverse events, and the safety profile of the once-daily formulation remained consistent with the company's currently marketed twice-daily formulation of the drug.
Ista has discussed the data with the U.S. Food and Drug Administration and plans to perform a confirmatory phase 3 trial in 2009, according to the release.