The systemic safety of bromfenac ophthalmic solution 0.09%

The aim of this study was to evaluate the systemic safety of a commercially available bromfenac ophthalmic solution 0.09% for the treatment of postoperative inflammation and reduction of ocular pain in subjects who have undergone cataract extraction.

Two phase III, multicenter, randomized, double-masked, parallel, placebo-controlled, clinical trials were conducted under a common protocol. These data were pooled for analysis.

The setting for this study was a series of multicentered, private, and university-affiliated ophthalmology clinics in the United States.

A total of 527 subjects were sequentially assigned, according to a computer-generated randomization list (2:1) to either bromfenac (n = 356) or placebo (n = 171). Potential subjects were excluded if using nonsteroidal anti-inflammatory drugs (NSAIDs), steroids, anticoagulants, or with uncontrolled ocular or systemic disease, preexisting ocular inflammation, surgical complications, or liver chemistry values of > or =Grade 1 according to World Health Organization Common Toxicity Criteria scoring.

Subjects who underwent cataract surgery without prior anti-inflammatory treatment and had a postsurgical Summed Ocular Inflammation Score (SOIS) of > or =3 were treated with either bromfenac or placebo. Subjects self-instilled 1 drop of the assigned test agent twice-daily for 14 days and were followed for an additional 14 days for safety evaluation.

Safety data were collected and the results for systemic safety are reported in this paper.

Five hundred and twenty-seven (527) subjects comprised the safety population. A total of 290 of 356 bromfenac and 93 of 171 placebo subjects received 28 doses of test agent. No clinically significant treatment-related systemic adverse effects or changes in liver chemistries were observed.

Bromfenac ophthalmic solution 0.09% demonstrated neither treatment-related systemic adverse events nor evidence of hepatic toxicity.