Once-daily bromfenac approved

November 1, 2010

ISTA Pharmaceuticals announced Oct. 16 that it had received FDA approval to market bromfenac ophthalmic solution 0.09% as a once-daily treatment for inflammation and reduction of ocular pain in patients who had undergone cataract surgery.

The once-daily product is being sold under the trade name Bromday. It is the same formulation of bromfenac as Xibrom (ISTA Pharmaceuticals), which has been marketed in the United States since 2005 for twice-daily use in treating inflammation and pain after cataract surgery, but Bromday received a once-daily indication based on evidence of its efficacy in two pivotal trials. According to the prescribing information, once-daily treatment with bromfenac 0.09% should be started one day prior to surgery with dosing continuing on the day of surgery and for 14 days after the procedure.

The total set of efficacy data for once-daily bromfenac 0.09% comprises three placebo-controlled studies (two of which the FDA selected as the pivotal trials) and the bromfenac 0.09% arm of a study comparing once-daily dosing of two concentrations of bromfenac; the efficacy dataset includes 584 patients taking once-daily bromfenac and 288 placebo-treated controls.

The studies enrolled patients scheduled to undergo cataract surgery and initiated treatment of the assigned study agent on the day before surgery. Corticosteroid use was allowed only as a rescue medication. The proportions of patients in each treatment group achieving absence of ocular inflammation on postoperative day 15 (Summed Ocular Inflammation Score [SOIS] = 0) was assessed as the primary efficacy endpoint.