Non-steroidal anti-inflammatory agent superior to placebo in studies

November 12, 2007

Results were presented for two phase III clinical trials of an ocular, non-steroidal anti-inflammatory agent, bromfenac (Xibrom, ISTA Pharmaceuticals). These results were presented by William B. Trattler, MD, at the 2007 annual meeting of the American Academy of Ophthalmology in New Orleans. The new once-daily formulation was evaluated versus placebo in more than 500 patients who underwent cataract surgery.

Results were presented for two phase III clinical trials of an ocular, non-steroidal anti-inflammatory agent, bromfenac (Xibrom, ISTA Pharmaceuticals). These results were presented by William B. Trattler, MD, at the 2007 annual meeting of the American Academy of Ophthalmology in New Orleans. The new once-daily formulation was evaluated versus placebo in more than 500 patients who underwent cataract surgery.

The findings demonstrated that the product was superior to placebo, 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, reported Dr. Trattler. There was an overall lower, incidence of ocular adverse events compared with placebo.

In addition, a poster presentation at the meeting demonstrated that the currently marked twice-daily formulation of bromfenac was as effective as both diclofenac sodium 0.1% ophthalmic solution or ketorolac tromethamine 0.5% ophthalmic solution. These are each dosed four times daily, when used for 3 months in the treatment of cystoid macular edema following uncomplicated cataract surgery.