Tobramycin and Prednisolone Combination for Inflammatory Ocular Conditions
Apr 28, 2005 - 10:25:00 AM
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"This new combination ophthalmic product was developed by ISTA and is a fixed combination of tobramycin and prednisolone acetate in a proprietary formulation that we believe will provide greater patient comfort in inflamed eyes. Both of the active ingredients in the product are approved drugs on their own. Based upon the timely commencement of the Phase III clinical trials this year, we would expect to submit a New Drug Application (NDA) to the FDA during the first half of 2006."
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By ISTA Pharmaceuticals, Inc.,
[RxPG] ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA - News) announced today that the Company has filed an Investigational New Drug (IND) application with the U.S. Food & Drug Administration (FDA) to initiate a U.S. Phase III study of a new combination ophthalmic product containing tobramycin and prednisolone acetate for the treatment of steroid-responsive inflammatory ocular conditions where risk of bacterial infection exists.
Vicente Anido, Jr., Ph.D., ISTA's Chief Executive Officer, stated, "This new combination ophthalmic product was developed by ISTA and is a fixed combination of tobramycin and prednisolone acetate in a proprietary formulation that we believe will provide greater patient comfort in inflamed eyes. Both of the active ingredients in the product are approved drugs on their own. Based upon the timely commencement of the Phase III clinical trials this year, we would expect to submit a New Drug Application (NDA) to the FDA during the first half of 2006."
The tobramycin and prednisolone acetate combination product, if approved, will compete in the antibiotic steroid segment of the U.S. topical ophthalmic anti-inflammatory market. Based upon management estimates of sales and 2004 prescription data from IMS Health, 2004 sales in the U.S. topical ophthalmic anti-inflammatory market were approximately $400 MM, with total prescriptions of 8.6 million.
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Additional information about the news article
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ABOUT ISTA
ISTA is a specialty pharmaceutical company focused on the development and commercialization of unique and uniquely improved ophthalmic products. ISTA's products and product candidates seek to address serious diseases and conditions of the eye such as dry eye, vitreous hemorrhage, diabetic retinopathy, hyphema, glaucoma, ocular pain and inflammation. Building on this pipeline, ISTA's goal is to continue its growth as a specialty pharmaceutical company by acquiring complementary products, either already marketed or in late-stage development. For more information, please visit the company's web site 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 the expected timing and outcome of the tobramycin and prednisolone acetate combination product Phase III clinical trials (including but not limited to the results such trials are expected to show), the expected timing of the filing of the tobramycin and prednisolone acetate combination product NDA, and the possibility of FDA approval of tobramycin and prednisolone acetate combination product, are forward-looking statements. ISTA disclaims any intent or obligation to update any forward-looking statements. Such 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: delays, risks and uncertainties related to ISTA's research and development programs (including the difficulty of predicting the timing or outcome of tobramycin and prednisolone acetate combination product development efforts, clinical studies and results, or FDA or other regulatory agency approval or actions); uncertainties and risks regarding the continued timely performance by ISTA's strategic partners of their respective obligations under existing collaborations; risks and uncertainties related to successful compliance with FDA and/or other governmental regulations applicable to ISTA's or its contractors' facilities, products and/or business, respectively; 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; uncertainties and risks regarding the impact of competitive products (either already marketed or under development); and, such 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, 2004.
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