ISTA Pharmaceuticals Announces Results of Clinical Trial of XibromQD (Once-Daily) Formulation
IRVINE, Calif., April 01, 2008, 2008 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. , today reported topline results of a clinical trial of Xibrom(TM) (bromfenac sodium ophthalmic solution) QD (once-daily) 0.18% formulation, a new formulation of ISTA's ocular, non- steroidal anti-inflammatory agent. The findings demonstrated equivalence between the 0.18% formulation and ISTA's 0.09% formulation of Xibrom given once daily in achieving the primary efficacy endpoint of absence of ocular inflammation 15 days following surgery. The data also showed no statistically significant difference between the two formulations in achieving the secondary efficacy endpoints of elimination of ocular pain and mean reduction of markers of inflammation (inflammatory cells and flare). In addition, the results indicated both formulations of bromfenac produced a low overall incidence of ocular adverse events.
"We undertook this trial in connection with our Xibrom QD NDA application, which was submitted to the FDA in December 2007. The nearly identical performance of the two concentrations was unexpected and inconsistent with the previously available data. The results suggest the 0.09% formulation is near the top of the dose-response curve," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA Pharmaceuticals. "Our next steps are to complete the data analysis and speak with the FDA to determine a possible path forward, as well as consider other options in terms of new Xibrom products. Part of our discussions will be to review the possibility of a label change for the currently marketed 0.09% formulation of Xibrom so that it can be administered once-daily."
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 is 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.
ABOUT ISTA PHARMACEUTICALS
ISTA Pharmaceuticals is an ophthalmic pharmaceutical company. ISTA's products and product candidates addressing the $4.7 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 that refer 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 related to the completion of the data analysis and discussions with the FDA regarding the Xibrom QD NDA or possible new Xibrom products and the possibility of a label change for the currently marketed 0.09% formulation of Xibrom, bringing a new product to market every 12 to 18 months, and becoming the leading niche ophthalmic pharmaceutical company 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: timely and successful implementation of ISTA's strategic initiatives; delays and uncertainties related to ISTA's research and development programs (including the difficulty of predicting the timing or outcome of product development efforts and the FDA or other regulatory agency approval or actions); uncertainties and risks regarding market acceptance of and demand for ISTA's approved products and the impact of competitive products and pricing; uncertainties and risks related to ISTA's ability to properly manage its growth; uncertainties and risks regarding the continued timely performance by ISTA's strategic partners of their respective obligations under existing collaborations and licensing arrangements; 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, 2007.
Posted: April 2008