ISTA Pharmaceuticals's Once-Daily Ocular Inflammation Drug Meets Goal
IRVINE, Calif., Nov. 12 -- ISTA Pharmaceuticals presented today results from the Company's two Phase III clinical trials of Xibrom(TM) (bromfenac sodium ophthalmic solution) QD (once- daily) formulation, a new formulation of ISTA's ocular, non-steroidal anti- inflammatory agent. The multi-center studies evaluated the new once-daily formulation of Xibrom versus placebo in over 500 patients who underwent cataract surgery. The highly statistically significant findings demonstrated Xibrom QD (once-daily) was superior to placebo (P less than or equal to 0.0001) in achieving both the primary efficacy endpoint of absence of ocular inflammation 15 days following surgery and the secondary efficacy endpoint of elimination of ocular pain at day one. In addition, compared to placebo, bromfenac produced a lower overall incidence of ocular adverse events. William B. Trattler, M.D. presented the results during the 2007 Annual Meeting of the American Academy of Ophthalmology (AAO) being held in New Orleans, Louisiana.
ISTA also announced today a second poster presentation at the AAO meeting. This study demonstrated the currently marketed twice-daily formulation of Xibrom was as effective as both diclofenac sodium 0.1% ophthalmic solution or ketorolac 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.
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 a Once Daily Bromfenac Ophthalmic Solution for Ocular Surgery
Contributing authors: William B. Trattler, MD; Peter A. Rapoza, MD; James H. 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 and continued through post-surgery day 14. Elimination of ocular pain was assessed at Day 1 and complete absence of ocular inflammation was assessed on Day 15.
Sunday, November 11th; 2pm - 3:30pm, Location: Morial Convention Center, Hall D
Abstract: Bromfenac Versus Diclofenac Versus Ketorolac in the Treatment of Acute 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 after uncomplicated cataract surgery were treated for 3 months as follows: approximately half of the patients with Xibrom twice daily, and 30 each with either diclofenac or ketorolac four times daily. Visual acuity was measured with Early Treatment Diabetic Retinopathy Study (ETDRS) charts. While no significant difference in ETDRS letters gained was noted between the three treatment groups, the patients treated with Xibrom recorded the greatest gain in visual function.
Xibrom(TM) (bromfenac ophthalmic solution)
Xibrom is a topical non-steroidal anti-inflammatory compound for the treatment of ocular inflammation and pain. Xibrom is the first and only FDA-approved twice-daily NSAID for inflammation and pain following cataract surgery. In 2006, Xibrom became the second highest-prescribed topical NSAID by ophthalmologists on a dollar basis, according to IMS data. Xibrom, under a different trade name but identical formulation, was launched in Japan in 2000 by Senju Pharmaceuticals Co. Ltd. ISTA acquired U.S. marketing rights for Xibrom in 2002 and launched the product in the U.S. in 2005.
ISTA Pharmaceuticals is an ophthalmic pharmaceutical company. ISTA's products and product candidates addressing the $3.2 billion U.S. prescription ophthalmic industry include therapies for inflammation, ocular pain, glaucoma, allergy, and dry eye. The Company currently markets three products and is developing a strong product pipeline to fuel future growth and market share. The Company's product development and commercialization strategy is to launch a new product every 12 to 18 months, thereby continuing its growth to become the leading niche ophthalmic pharmaceutical company in the U.S. For additional information regarding ISTA, please visit ISTA Pharmaceuticals' website at http://www.istavision.com.
Any statements contained in this press release referring to future events or other non-historical matters are forward-looking statements. Without limiting the foregoing, but by way of example, statements contained in this press release concerning prospects related to the projected timelines for filing of a supplemental New Drug Application for Xibrom QD (once-daily) with the Food and Drug Administration and the expected approval of ISTA's application, the Company's expectation patients and physicians will choose Xibrom QD (once-daily) over other ophthalmic NSAID formulations, and ISTA's goals of bringing a new product to market every 12 to 18 months and becoming the leading niche ophthalmic pharmaceutical company in the U.S., are forward-looking statements. Except as required by law, ISTA disclaims any intent or obligation to update any forward-looking statements. These forward- looking statements are based on ISTA's expectations as of the date of this press release and are subject to risks and uncertainties that could cause actual results to differ materially. Important factors that could cause actual results to differ from current expectations include, among others: the inherent uncertainty associated with financial projections and estimates, timely and successful implementation of ISTA's strategic initiatives; delays and uncertainties related to ISTA's research and development programs (including without limitation the difficulty of predicting the timing or outcome of bepotastine product development efforts); the timing, scope, and outcome of FDA or other regulatory agency approval or actions; uncertainties and risks regarding market acceptance of and demand for ISTA's approved products; the impact of competitive technologies, products, and pricing; uncertainties and risks related to ISTA's ability to properly manage its growth; uncertainties and risks related to the continued availability of third-party sourced products and raw materials on commercially reasonable terms, or at all; uncertainties and risks related to successful compliance with FDA and/or other governmental regulations applicable to ISTA's facilities, products, and/or business; uncertainties and risks related to the scope, validity, and enforceability of patents related to ISTA's products and technologies and the impact of patents and other intellectual property rights held by third parties; and such other risks and uncertainties as detailed from time to time in ISTA's public filings with the U.S. Securities and Exchange Commission, including but not limited to ISTA's Annual Report on Form 10-K for the year ended December 31, 2006 and its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2007, June 30, 2007 and September 30, 2007.