ISTA Pharmaceuticals Announces Physician-Sponsored Clinical Studyof Xibrom Combination Therapy with LucentisPresentation is One of Five Posters Scheduled for the 2008 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO)
IRVINE, Calif., February 22, 2008 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. , announced today the acceptance of an abstract describing the results of a study using Xibrom(TM) (bromfenac ophthalmic solution) 0.09% therapy in combination with Lucentis(R) (ranibizumab injection) in patients with age-related macular degeneration (AMD). According to the abstract, patients who received Xibrom required 1.6 +/- 0.69 injections of Lucentis during the six-month study period, while patients who received only Lucentis received 4.5 +/- 0.41 injections. Patients with Lucentis alone received significantly more (2.83 times) injections of ranibizumab (p=0.0002) than those receiving the combination. There was a numerical trend in favor of the combination treatment group on improvement in visual acuity but this difference did not achieve statistical significance. These data are expected to be presented at the ARVO 2008 annual meeting, which begins at the end of April.
The study results were gathered from 60 patients receiving Lucentis therapy for wet AMD. Patients were monitored monthly using optical coherence tomography (OCT) and fluorescein angiography. When leakage from vessels was detected, patients were re-injected with Lucentis. 30 patients received Xibrom dosed twice daily in addition to the Lucentis injection, and their results were compared to 30 patients who received Lucentis only. There were no adverse events associated with the extended topical administration of bromfenac. The study was designed as a retrospective case control series.
The clinical findings will be presented on Sunday April 27, 2008 from 11 am - to 12:45 pm by Calvin A. Grant, M.D., author of the study, in a poster (#A531) titled, "Combination Therapy: Lucentis (ranibizumab injection) and Xibrom (bromfenac ophthalmic solution) 0.09% in the Treatment of CNV Membrane Secondary to AMD".
"We are very excited about these preliminary results and look forward to exploring this effect further," stated Timothy R. McNamara, Pharm.D., Vice President, Clinical Research and Medical Affairs of ISTA. "ISTA intends to initiate additional studies to confirm these findings and explore the potential to enhance patient safety and response in wet AMD therapy."
Additional Poster Presentations scheduled for the 2008 ARVO Meeting, which will be held at the Greater Fort Lauderdale/Broward County Convention Center:
Thursday, May 1st; 10:45 am - 12:30 pm; Poster # A593: Efficacy of Bromfenac Ophthalmic Solution Administered Once Daily for Ocular Inflammation and Pain Associated With Cataract Surgery; Steven M. Silverstein, M.D., et al
Tuesday, Apr 29th; 8:30 am - 10:15 am; Poster # A486: The Incidence of Macular Edema from Two Integrated Phase III Clinical Trials of Bromfenac Ophthalmic Solution Administered Once Daily for Cataract Surgery; Thomas R. Walters, M.D., et al
Wednesday, April 30th; 3:00 pm - 4:45 pm; Poster # A548: Effects of Bromfenac Sodium on Acute and Chronic Uveitis in Rabbits; Takahiro Ogawa, Ph.D., et al
Sunday, April 27th; 8:30 am - 10:15 am; Poster #D946: Evaluation of Aqueous Humor Concentrations of Istalol(R) and Betimol(R) following Ocular Instillation into the Eyes of New Zealand White Rabbits; George A. Baklayan, et al
About Xibrom(TM) (bromfenac ophthalmic solution)
Xibrom is a topical non-steroidal anti-inflammatory compound for the treatment of ocular inflammation and pain. Xibrom, approved in 2005, is the first and only FDA-approved twice-daily NSAID for inflammation and reduction of pain following cataract surgery. Xibrom was the fastest-growing ophthalmic product in 2007, 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.
Istalol is a once-daily, topical solution of timolol, a beta-blocking agent for the treatment of glaucoma. ISTA holds exclusive marketing rights to Istalol in the United States under license from Senju Pharmaceutical Co., Ltd., which developed the product in Japan.
ABOUT ISTA PHARMACEUTICALS
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.
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 presentation of data at the ARVO 2008 annual meeting, ISTA initiating further studies on the combination use of Xibrom and Lucentis, 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.
Posted: February 2008