Xibrom QD Formulation Trial Demonstrated Efficacy
ISTA Pharmaceuticals presented results from two Phase III clinical trials of Xibrom (bromfenac sodium ophthalmic solution) QD (once- daily) formulation, a new formulation of ISTA's ocular, non-steroidal anti- inflammatory agent.
The multi-center studies evaluated the new once-daily formulation of Xibrom versus placebo in over 500 patients who underwent cataract surgery. The highly statistically significant findings demonstrated Xibrom QD (once-daily) was superior to placebo (P less than or equal to 0.0001) in achieving both the primary efficacy endpoint of absence of ocular inflammation 15 days following surgery and the secondary efficacy endpoint of elimination of ocular pain at day one.
In addition, compared to placebo, bromfenac produced a lower overall incidence of ocular adverse events. William B. Trattler, M.D. presented the results during the 2007 Annual Meeting of the American Academy of Ophthalmology (AAO) being held in New Orleans, Louisiana.
ISTA also announced today a second poster presentation at the AAO meeting. This study demonstrated the currently marketed twice-daily formulation of Xibrom was as effective as both diclofenac sodium 0.1% ophthalmic solution or ketorolac tromethamine 0.5% ophthalmic solution, each dosed four times daily, when used for 3 months in the treatment of cystoid macular edema (CME) following uncomplicated cataract surgery.