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ISTA also announced today a second poster presentation at the AAO meeting.This study demonstrated the currently marketed twice-daily formulation ofXibrom was as effective as both diclofenac sodium 0.1% ophthalmic solution orketorolac tromethamine 0.5% ophthalmic solution, each dosed four times daily,when used for 3 months in the treatment of cystoid macular edema (CME)following uncomplicated cataract surgery.
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Poster Presentations at AAO Meeting:
Monday, November 12th; 12pm - 2pm, Location: Morial Convention Center,Hall D
Abstract # 0259: Integrated Results from 2 Phase III Clinical Trials of aOnce Daily Bromfenac Ophthalmic Solution for Ocular Surgery
Contributing authors: William B. Trattler, MD; Peter A. Rapoza, MD; JamesH. Peace, MD; Y. Ralph Chu, MD; Thomas R. Walters, MD; Robert H. Stewart, MD;Ralph Bianca, PhD; James A. Gow, MD; Timothy R. McNamara, PharmD.
A total of 542 patients were enrolled in two randomized, double-masked,placebo-controlled studies under the same protocol at 39 sites in the U.S.Subjects were assigned randomly to receive either Xibrom once-daily or placebo(n=360) or (n=182). Dosing began one day before cataract surgery andcontinued through post-surgery day 14. Elimination of ocular pain wasassessed at Day 1 and complete absence of ocular inflammation was assessed onDay 15.
Sunday, November 11th; 2pm - 3:30pm, Location: Morial Convention Center,Hall D
Abstract: Bromfenac Versus Diclofenac Versus Ketorolac in the Treatment ofAcute Pseudophakic Cystoid Macular Edema
Contributing authors: David S. Rho, MD, Rochelle E. Tractenberg, PhD,Bruce J. Markovitz, MD, Stephen M. Soll, MD.
In this study, 122 patients with acute CME within 1 year afteruncomplicated cataract surgery were treated for 3 months as follows:approximately half of the patients with Xibrom twice daily, and 30 each witheither diclofenac or ketorolac four times daily. Visual acuity was measuredwith Early Treatment Diabetic Retinopathy Study (ETDRS) charts. While nosignificant difference in ETDRS letters gained was noted between the threetreatment groups, the patients treated with Xibrom recorded the greatest gainin visual function.
Xibrom(TM) (bromfenac ophthalmic solution)
Xibrom is a topical non-steroidal anti-inflammatory compound for thetreatment of ocular inflammation and pain. Xibrom is the first and onlyFDA-approved twice-daily NSAID for inflammation and pain following cataractsurgery. In 2006, Xibrom became the second highest-prescribed topical NSAIDby ophthalmologists on a dollar basis, according to IMS data. Xibrom, under adifferent trade name but identical formulation, was launched in Japan in 2000by Senju Pharmaceuticals Co. Ltd. ISTA acquired U.S. marketing rights forXibrom in 2002 and launched the product in the U.S. in 2005.
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