ISTA to seek bromfenac label change

September 2, 2009

ISTA Pharmaceuticals plans to ask the FDA to approve a change to the label of its bromfenac 0.09% ophthalmic solution after obtaining positive preliminary phase III results in a confirmatory clinical study of once-daily bromfenac (Xibrom QD) for the treatment of inflammation and pain after cataract surgery.

Irvine, CA —ISTA Pharmaceuticals plans to ask the FDA to approve a change to the label of its bromfenac 0.09% ophthalmic solution after obtaining positive preliminary phase III results in a confirmatory clinical study of once-daily bromfenac (Xibrom QD) for the treatment of inflammation and pain after cataract surgery. The topical non-steroidal anti-inflammatory compound currently is labeled for twice-daily use beginning 24 hours after such surgeries.

Statistically significant results were achieved related to the study’s primary endpoint, the absence of ocular inflammation 15 days after cataract surgery, and the secondary efficacy endpoint, the elimination of ocular pain 1 day after surgery, according to the company. Also, no serious ocular or systemic adverse events occurred, and the safety profile is consistent with the currently marketed formulation, a press release said.

The study was a multicenter, randomized, double-masked, parallel-group trial involving 299 patients who underwent cataract surgery in one eye. Patients were assigned randomly 1:1 to receive either once-daily bromfenac 0.09% or placebo. Dosing began 1 day before cataract surgery and continued for 14 days after surgery.

In December, ISTA announced integrated results of two phase III studies with once-daily bromfenac. Based on the results of the studies, the FDA required the company to conduct an additional confirmatory study with once-daily bromfenac. The current study confirms the efficacy and safety of once-daily bromfenac previously demonstrated in an identical phase III clinical trial last year, according to ISTA.

The company expects to complete its analysis of the full data set from the confirmatory study and file a supplemental new drug application with the FDA, seeking approval of bromfenac as a once-daily treatment for inflammation and pain after cataract surgery, before the end of the year.