Dr. Calvin Grant Presents Results from Xibrom Combination Therapywith Lucentis at the 2008 Annual Meeting of the Association forResearch in Vision and Ophthalmology (ARVO)
TAMPA, Fla., April 27, 2008 /PRNewswire-FirstCall/ -- Calvin A. Grant, MD, Retina Macular Care, presented the results from his 60-patient retrospective case control study that was designed to evaluate the adjuvant use of Xibrom(TM) (bromfenac 0.09mg ophthalmic solution) in Lucentis(R) (ranibizumab) treatment of choroidal neovascularization secondary to age-related macular degeneration (AMD) in an oral poster presentation at the 2008 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO). Dr. Grant reported patients who received Xibrom in addition to Lucentis (the Combination Group) required 1.6 +/- 0.69 injections of Lucentis during the six-month study period, while patients who received Lucentis only received 4.5 +/- 0.41 injections (p=0.0002). The original abstract, which was published in February 2008, stated there was a numerical trend in favor of the Combination Group on improvement in visual acuity but this difference did not achieve statistical significance. However, upon rigorous review and further statistical analysis, the data has shown the Combination Group did show a statistically significant improvement in visual acuity. In the Combination Group, mean visual acuity increased 1.2 +/- 1.64 lines compared with 0.06 +/-0.66 lines in patients in the Lucentis-only group (p=0.001).
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 subretinal fluid from leaking vessels was detected by OCT, patients were re-injected with Lucentis. 30 patients received Xibrom dosed twice daily in addition to the Lucentis injection (the Combination Group), 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.
ISTA Pharmaceuticals supported Dr. Grant's study with an unrestricted educational grant. Xibrom is not approved for use in the treatment of AMD or in adjunctive use with Lucentis. These results will need to be confirmed through clinical studies, and, should ISTA decide to pursue a potential label change, ISTA would speak with the US Food and Drug Administration (FDA) to determine the Agency's requirements.
Lucentis(R) is a registered trademark of Genentech.
About Xibrom(TM) (bromfenac ophthalmic solution)
Xibrom is a topical non-steroidal anti-inflammatory compound for the treatment of ocular inflammation and pain following cataract surgery. 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.
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 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, 2007.
Posted: April 2008