Mechanism of Action

Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that has anti-inflammatory activity. The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2.

Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure.

Pharmacokinetics

The plasma concentration of bromfenac following ocular administration of 0.09% XIBROM (bromfenac ophthalmic solution) in humans is unknown. Based on the maximum proposed dose of one drop to each eye (0.09mg) and PK information from other routes of administration, the systemic concentration of bromfenac is estimated to be below the limit of quantification (50 ng/mL) at steady-state in humans.

Clinical Trials

Clinical efficacy was evaluated in two randomized, double-masked, placebo-controlled U.S. trials in which subjects with a summed ocular inflammation score 3 after cataract surgery were assigned to XIBROM (bromfenac ophthalmic solution ) or placebo in a 2:1 ratio following surgery. One drop of XIBROM (bromfenac ophthalmic solution ) or vehicle was self-instilled in the study eye twice a day for 14 days, beginning the day after surgery. The primary endpoint was reduction of ocular inflammation (to trace inflammation or clearing) assessed 14 days post-surgery using a slit lamp binocular microscope. In the intent-to­treat analyses of both studies, a significant effect of XIBROM (bromfenac ophthalmic solution ) on ocular inflammation after cataract surgery was demonstrated (62-66% vs. 40-48%).

Last reviewed on RxList: 6/23/2009
This monograph has been modified to include the generic and brand name in many instances.