ISTA Pharmaceuticals Announces Positive Preliminary Xibrom(TM) Once-daily Formulation Clinical Results From U.S. Phase III Trials
- Category: Small Molecules
- Published on Friday, 09 February 2007 02:00
- Hits: 1912
IRVINE, CA, USA | Feb 08, 2007 | ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced highly statistically significant results from its initial analysis of the Company's U.S. Phase III clinical trials of Xibrom(TM) (bromfenac sodium ophthalmic solution) once-daily formulation. The multi-center studies evaluated Xibrom once-daily formulation versus placebo in over 500 patients who underwent cataract surgery. The preliminary results of the Xibrom Phase III trials demonstrated Xibrom was highly statistically significant in treating post-operative ocular pain and inflammation associated with cataract surgery. Based upon preliminary analyses, the safety profile is consistent with the currently marketed Xibrom formulation. The Xibrom once-daily formulation contains both a higher concentration of the active ingredient, bromfenac, and a new formulation compared to the original twice-daily product. If FDA-approved, this Xibrom formulation will provide patients with the most significant improvement to date in treating ocular pain and inflammation associated with cataract surgery, as it will be the only available once-a-day treatment.
Based upon the preliminary results of the studies and pending final analyses, ISTA plans to file a supplemental New Drug Application (sNDA) with the U.S. Food & Drug Administration in the second half of 2007 for the Xibrom once-daily formulation for the treatment of ocular pain and inflammation associated with cataract surgery.
"We believe these data represent the successful achievement of our efforts to improve upon Xibrom, our flagship product. The once-daily formulation will provide the most potent and conveniently dosed ophthalmic NSAID to patients undergoing cataract surgery. As studies show time and again, less-frequent dosing improves patient compliance, and we believe patients will benefit significantly should Xibrom once-daily receive FDA approval," stated Vicente Anido, Jr., Ph.D., ISTA's President and Chief Executive Officer. "We plan to complete our analysis of the Phase III data and announce detailed final results from these studies in a peer-reviewed forum."
Xibrom is a topical non-steroidal anti-inflammatory compound for the treatment of ocular inflammation and pain. 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 May 2002 and launched the product in the U.S. in June 2005. Xibrom is the first and only FDA-approved twice-daily NSAID for inflammation and pain following cataract surgery, and in 2006, Xibrom became the second highest-prescribed topical NSAID by ophthalmologists on a dollar basis according to IMS data.
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 allergy, dry eye, vitreous hemorrhage, diabetic retinopathy, hyphema, glaucoma, ocular pain, and inflammation. 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 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 ISTA's plan to submit to the FDA an sNDA for the Xibrom once-daily formulation in the second half of 2007 and FDA's subsequent acceptance and approval of this sNDA, ISTA's plan to complete its analysis of the Xibrom once-daily Phase III data and announce in the future detailed final results in a peer-reviewed forum, the assumption that final results of the Xibrom once-daily Phase III data will be consistent with the preliminary results and support the filing of an sNDA, the potential benefits of Xibrom once-daily, if approved by FDA, for patients as compared to other currently marketed therapies, and ISTA's strategic objective to launch a new product every 12 to 18 months, thereby continuing its growth toward its goal of 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 risk that full analysis of the Xibrom once-daily Phase III data will not reflect the preliminary Phase III results reported in this press release or be sufficient to support the submission of an sNDA; timely and successful implementation of ISTA's strategic initiatives; delays and uncertainties related to ISTA's research and development program (including the difficulty of predicting the timing or outcome of the Xibrom once-daily 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 (Xibrom once-daily if approved by FDA) and the impact of competitive products and pricing; 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, 2005, and its Form 10Q for the quarters ended March 31, 2006, June 30, 2006, and September 30, 2006.
SOURCE: ISTA Pharmaceuticals, Inc