ISTA Pharmaceuticals Files New Drug Application With U.S. Food And Drug Administration For T-Pred(TM), A Tobramycin And Prednisolone Acetate Product

Main Category: Eye Health / Blindness
Also Included In: Infectious Diseases / Bacteria / Viruses;  Clinical Trials / Drug Trials
Article Date: 07 Jul 2006 - 0:00 PDT

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ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA) announced today that the Company has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for its investigational ophthalmic product, T-Pred(TM), containing tobramycin and prednisolone acetate in a fixed combination. The Company is seeking approval for T-Pred as a treatment for inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial ocular infections or a risk of bacterial infections exists.

According to 2005 IMS Health data, prednisolone acetate is the most prescribed ophthalmic steroid, and tobramycin is the most prescribed aminoglycocide antibiotic solution by ophthalmologists in the United States.

"We are pleased with the successful and timely achievement of this regulatory milestone in the development of T-Pred. This product candidate represents ISTA's commitment to bringing novel or uniquely improved products to ophthalmologists and their patients. If approved, we believe T-Pred will offer patients a powerful new treatment combining fast anti-inflammatory relief with excellent anti-bacterial coverage," stated Vicente Anido, Ph.D., President and Chief Executive Officer of ISTA Pharmaceuticals. "Pending acceptance and timely approval of our T-Pred(TM) NDA submission, we anticipate a potential launch of this product in mid-2007."

ABOUT TOBRAMYCIN AND PREDNISOLONE ACETATE COMBINATION PRODUCT

In the fourth quarter of 2005, ISTA completed its U.S. Phase III study of its combination product containing tobramycin and prednisolone acetate for the treatment of inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial ocular infections or a risk of bacterial infections exists. The multi-center, randomized, double-masked U.S. Phase III trial successfully achieved its primary endpoint, demonstrating bioequivalence of prednisolone between ISTA's combination product (prednisolone acetate 1.0% and tobramycin 0.3%) and prednisolone acetate 1.0%. To demonstrate the two products were bioequivalent, the ratio of the concentrations of prednisolone needed to establish bioequivalence must fall between 80% and 125%, with 90% confidence. ISTA's combination product achieved or exceeded its goal both in the intent-to-treat and the per-protocol patient populations.

ISTA expects its 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's estimates and IMS Health 2005 prescription data, ISTA estimates 2005 sales in the U.S. topical ophthalmic anti-inflammatory market exceeded $400 million, with total prescriptions of approximately 8.8 million.

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 through a combination of its own product development efforts and by acquiring complementary products and product candidates. For additional information regarding ISTA, please visit ISTA Pharmaceuticals' Website at http://www.istavision.com.

FORWARD-LOOKING STATEMENT

Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements. For example, and without limiting the foregoing, the statement that ISTA plans to launch the T-Pred(TM) product in mid-2007 if approved, is a forward-looking statement. 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 from current expectations. Important factors that could cause actual results to differ from current expectations include, among others: delays, risks, and uncertainties related to ISTA's product development activities, including timely FDA acceptance and approval of the NDA for the T-Pred(TM) product, as well as 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2006.

ISTA Pharmaceuticals, Inc.
http://www.istavision.com