ISTA: study shows twice-daily dosing of Xibrom improves visual acuity in macular edema

By Lisa Kerner

Erie, Pa., May 4 - ISTA Pharmaceuticals, Inc. said results of a physician-sponsored clinical trial of Xibrom (bromfenac ophthalmic solution) show patients treated with Xibrom achieved statistically significant improvements in both visual acuity and EDTRS letters gained after three months of treatment.

The improvements were equivalent to those after treatment with Voltaren Ophthalmic (diclofenac sodium ophthalmic solution) 0.1% and Acular (ketorolac tromethamine ophthalmic solution) 0.5% after three months of treatment.

Xibrom is a topical, twice-daily non-steroidal anti-inflammatory solution (Nsaid) approved by the Food and Drug Administration for the treatment of ocular inflammation and reduction of pain following cataract surgery, according to a company news release.

The trial was designed to compare the efficacy of Xibrom 0.09% with two topical Nsaids that were given four times a day for the treatment of acute pseudophakic cystoid macular edema (CME). A total of 52 patients with CME 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.

The data were presented in a poster session during the 2006 Association for Research in Vision and Ophthalmology Annual Meeting in Fort Lauderdale, Fla.

ISTA is an Irvine, Calif., specialty pharmaceutical company focused ophthalmic products.

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