Ista Pharmaceuticals has reported data from a clinical trial designed to compare the efficacy of Xibrom (bromfenac ophthalmic solution) 0.09 percent with two topical non-steroidal anti- inflammatory solutions (NSAIDs) that were given four times a day for the treatment of acute pseudophakic cystoid macular edema (CME).
According to the results of the trial, patients treated with Xibrom achieved statistically significant improvements in both visual acuity and EDTRS letters gained. Fifty-two patients with pseudophakic cystoid macular edema following cataract surgery were randomized to treatment according to one of three regimens: Xibrom one drop twice daily, Voltaren Ophthalmic one drop four times daily, and Acular one drop four times daily. Each patient was examined monthly for three months and measured for improvement in visual acuity using standardized ETDRS charts. None of the ophthalmic NSAIDs are indicated for the prevention or treatment of CME, an occasional complication of ocular surgery caused by swelling of the focusing area of the retina that can impair vision, although prior clinical investigations have demonstrated activity by the class in the condition.