Healthcare Industry News: Tobramycin
News Release - February 2, 2006
ISTA Pharmaceuticals Announces Positive Phase III Results for Tobramycin and Prednisolone Acetate Combination ProductISTA Plans to Submit NDA for Drug Candidate in First Half of 2006
Conference Call to be Held Today at 1:30 p.m. Eastern Time
IRVINE, Calif., Feb. 2 (HSMN NewsFeed) -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA ) today announced positive results from a Phase III bioequivalence study of ISTA's proprietary investigational combination ophthalmic product containing Tobramycin and prednisolone acetate for the treatment of steroid-responsive inflammatory ocular conditions where risk of bacterial infection exists. According to IMS Health data, prednisolone acetate is the most prescribed anti-inflammatory agent, and Tobramycin is the most prescribed aminoglycoside antibiotic solution by ophthalmologists in the United States.
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 (Tobramycin 0.3%/prednisolone acetate 1.0%) and prednisolone acetate 1.0%. To demonstrate that 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.
The trial's secondary endpoints were also achieved, demonstrating that ISTA's proprietary combination product and prednisolone acetate 1% had similar maximum concentrations (Cmax), and the time to reach maximum concentration (Tmax) was identical for both. The results also demonstrated that ISTA's combination product has a favorable safety profile, and no treatment-related adverse events were reported.
"We are pleased with the pharmacokinetic data from our Phase III study indicating bioequivalence in both the Intent-to-Treat and Per Protocol populations," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA Pharmaceuticals. "Based on our Phase III study results, we plan to submit to the U.S. Food and Drug Administration a New Drug Application (NDA) for our combination product in the first half of 2006. If approved, we believe our combination product could have a number of important advantages, including supplying prednisolone and Tobramycin in one formulation selected to provide greater patient comfort in inflamed eyes."
ISTA will host a conference call with a simultaneous webcast today, February 2, 2006 at 1:30 PM Eastern Time concerning its Phase III results for its combination product. To access the live conference call, U.S. and Canadian participants may dial 800-510-9834; international participants may dial 617-614-3669. To access the 24-hour audio replay, U.S. and Canadian participants may dial 888-286-8010; international participants may dial 617-801-6888. The access code for the replay is 11961356. This conference call will also be webcast live and archived on ISTA's website for 30 days at http://www.istavision.com.
About the Phase III Clinical Trial
A total of 132 patients undergoing bilateral cataract surgery were enrolled in the multi-center, randomized, double-masked U.S. Phase III trial and were randomly assigned to receive either ISTA's combination product or prednisolone acetate 1% in each eye. Of these 132 patients, 124 had a viable aqueous humor sample taken from each eye at the time of surgery at either 30, 60, 90, 120, 180 or 240 minutes following administration of the test agent.
About ISTA's Tobramycin and Prednisolone Acetate Combination Product
In the fourth quarter of 2005, ISTA completed its U.S. Phase III study of a combination product containing Tobramycin and prednisolone acetate for the treatment of steroid-responsive inflammatory ocular conditions where risk of bacterial infections exists. This new combination ophthalmic product was developed by ISTA and is a fixed combination of Tobramycin and prednisolone acetate in a proprietary formulation.
ISTA expects that 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 estimates and 2005 IMS Health prescription data, ISTA estimates that 2005 sales in the U.S. topical ophthalmic anti-inflammatory market exceeded $400 million, with total prescriptions of 8.8 million.
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, 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 additional information regarding ISTA, please visit ISTA Pharmaceuticals' Website at http://www.istavision.com/.
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 concerning ISTA's plan to submit an NDA for its combination product in the first half of 2006 is a forward-looking statement. Except as required by law, 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 and uncertainties related to ISTA's research and development programs for its combination product (including the difficulty of predicting the timing or outcome of ISTA's product development efforts and the FDA or other governmental agency approval or actions); 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 and ISTA's Quarterly Reports on Form 10-Q for the quarters ended March 31, 2005, June 30, 2005 and September 30, 2005.
Source: ISTA Pharmaceuticals
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