ISTA Reports Positive Preliminary Phase 3 Clinical Results For Xibrom 0.09%
To support sNDA filing for Xibrom 0.09%
ISTA Pharmaceuticals (ISTA) has reported positive preliminary phase 3 results from the company's Xibrom (bromfenac ophthalmic solution) 0.09% QD (once-daily) confirmatory clinical study.
Xibrom 0.09% QD achieved statistical significance in the study's primary endpoint, the absence of ocular inflammation 15 days following cataract surgery. It also achieved the secondary efficacy endpoint - the elimination of ocular pain one day post surgery.
The phase 3 study was a multi-center, randomized, double-masked, parallel-group study in 299 patients, who underwent cataract surgery in one eye.
In December 2008, ISTA announced integrated results from two phase 3 studies with Xibrom 0.09% QD. Based on the results of the studies, the FDA required ISTA to conduct an additional confirmatory study with Xibrom 0.09% QD.
The company said that the current study confirms the efficacy and safety of Xibrom 0.09% QD, which was previously demonstrated in an identical phase 3 clinical trial in 2008.
ISTA expects to file a supplemental New Drug Application (sNDA) with the FDA prior to the end of 2009, seeking approval of the Xibrom 0.09% formulation for once-daily treatment for the inflammation and pain following cataract surgery.
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