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Two once-daily bromfenac formulations show equivalent efficacy for inflammation after cataract surgery
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IRVINE, Calif. — A clinical trial comparing two once-daily formulations of bromfenac sodium ophthalmic solution found that both formulations showed equivalent efficacy for eliminating ocular inflammation 15 days after cataract surgery, according to a press release from Ista Pharmaceuticals, the developer of the drugs.
The data also showed no statistically significant difference between the 0.18% formulation and the 0.09% formulation of Xibrom (bromfenac sodium ophthalmic solution) in achieving the secondary efficacy endpoints of eliminating ocular pain and reducing markers of inflammation (inflammatory cells and flare).
In addition, both formulations produced a low overall incidence of ocular adverse events, the release said.
Ista initiated the trial in connection with its Xibrom QD new drug application, which it submitted to the U.S. Food and Drug Administration in December.
"The nearly identical performance of the two concentrations was unexpected and inconsistent with the previously available data. The results suggest the 0.09% formulation is near the top of the dose-response curve," Vicente Anido Jr., PhD, Ista's president and CEO, said in the release.
"Our next steps are to complete the data analysis and speak with the FDA to determine a possible path forward, as well as consider other options in terms of new Xibrom products. Part of our discussions will be to review the possibility of a label change for the currently marketed 0.09% formulation of Xibrom so that it can be administered once-daily," he said.