Xibrom(™) (bromfenac ophthalmic solution)
Xibrom is a topical non-steroidal anti-inflammatory compound for the treatment of ocular inflammation and pain following cataract surgery. Xibrom, under a different trade name but identical formulation, was launched in Japan in 2000 by Senju Pharmaceuticals Co. Ltd. ISTA acquired U.S. marketing rights for Xibrom in 2002 and launched the product in the U.S. in 2005. According to IMS data, Xibrom is the 2009 dollar market share leader in the U.S. ophthalmic nonsteroidal anti-inflammatory market, with net sales of $33.8 million for the six-month period ended June 30, 2009.
Xibrom currently is labeled as an eye drop used twice-daily beginning 24 hours after cataract surgery. Xibrom has not been approved by the FDA as a once-daily treatment. ISTA's sNDA filing will request the Agency to approve a change to the drug's label to reflect Xibrom's efficacy as a once-daily treatment in this patient population.
ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced 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, and the secondary efficacy endpoint, the elimination of ocular pain one day post surgery. During the study, no serious ocular or systemic adverse events occurred, and the safety profile is consistent with ISTA's currently marketed Xibrom twice-daily formulation.
