ISTA Pharmaceuticals, Inc. has announced positive preliminary Phase 3 results from a confirmatory clinical trial with Xibrom™ (bromfenac ophthalmic solution) 0.09% QD. Xibrom 0.09% QD reached statistical significance in the absence of ocular inflammation 15 days following cataract surgery, and in the elimination of ocular pain one day post surgery. During the study, there were no serious ocular or systemic adverse events and the safety profile is similar to the twice daily formulation.

This phase 3 study was a multi-center, randomized, double-masked, parallel-group study in 299 patients who underwent cataract surgery in one eye. The groups were randomized to either receive Xibrom once a day or placebo and received the eye drops for 14 days after cataract surgery.

The FDA had required ISTA to conduct an additional confirmatory study with the once-daily formulation based on the results from 2 previous studies. This current study confirms the efficacy and safety of Xibrom 0.09% QD. 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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