Global Experience With Xibrom (Bromfenac Ophthalmic Solution) 0.09%: The First Twice-daily Ophthalmic Nonsteroidal Anti-inflammatory Drug

Ophthalmic nonsteroidal anti-inflammatory drugs (NSAIDs) are becoming a cornerstone for the management of ocular pain and inflammation. Their well-characterized anti-inflammatory activity, analgesic property, and established safety record have also made NSAIDs an important tool to optimize surgical outcomes. Ophthalmic NSAIDs currently play four principal roles in ophthalmic surgery, including the prevention of intraoperative miosis during cataract surgery, management of postoperative inflammation, the reduction of pain and discomfort after cataract and refractive surgery, and the prevention and treatment of cystoid macular edema (CME) after cataract surgery. In clinical practice, an optimal ophthalmic NSAID therapy will have highly effective anti-inflammatory activity, a rapid onset of action that produces sustained relief of inflammation and pain, an excellent safety profile, a formulation that is comfortable and well-tolerated, and a convenient dosing regimen. Based upon its features, bromfenac ophthalmic solution 0.09% seems to satisfy each ideal NSAID parameter. This chapter will review the clinical and postapproval experience with bromfenac ophthalmic solution 0.09% (Xibrom, ISTA Pharmaceuticals, Inc., Irvine, CA). Bromfenac sodium ophthalmic solution 0.1% was first approved in May 2000 as Bronuck (Senju Pharmaceutical Company, Ltd., Osaka, Japan) and is presently approved by the Ministry of Health in Japan for the clinical indications of the treatment of postoperative inflammation, blepharitis, conjunctivitis, and scleritis. The same formulation was approved in the United States by the Food and Drug Administration (FDA) in March 2005 as Xibrom (bromfenac ophthalmic solution 0.09%)

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