�SurModics, Inc. (Nasdaq: SRDX), a leading provider of surface alteration and dose delivery technologies to the healthcare diligence, announced that Merck & Co., Inc. has informed the fellowship that, in light of results reported in a recently published study comparison laser discussion and intravitreal injections of triamcinolone acetonide (TA) in patients with diabetic macular edema (DME), Merck is reevaluating the design of its Phase IIb clinical trial for I-vation� TA. Pending this review, Merck is suspending enrollment of new patients in the Phase IIb clinical test. The License and Research Collaboration Agreement with Merck continues, and other ongoing development programs with Merck are untouched.
Merck's Phase IIb clinical trial is intended to evaluate the safety and efficacy of SurModics' I-vation TA in patients with DME. The suspension of the clinical trial follows the publication of a study sponsored by the National Eye Institute suggesting a benefit for laser treatment over intravitreal injections of TA. This lately published reputation does non discuss I-vation TA, nor did the study value the safety or efficaciousness of free burning drug livery systems.
"The decision to suspend enrollment in this clinical tribulation is based solely on the results reported in a lately published study comparing laser treatment and intravitreal injections of TA," said Bruce Barclay, president and CEO of SurModics. "We believe the data from the Phase I and Phase IIb clinical trials generated to date provide support for the tolerability profile of I-vation TA, and more by and large, that of the I-vation sustained delivery platform."
Additionally, SurModics remains committed to its ongoing development programs with multiple other customers pursuing the development of products incorporating SurModics' sustained delivery technologies, including the I-vation chopine, for the treatment of diseases of the optic.
About SurModics, Inc.
SurModics, Inc. is a leading provider of surface qualifying and drug delivery technologies to the healthcare industry. SurModics partners with the world's foremost medical device, pharmaceutical and life science companies to develop and commercialize groundbreaking products that result in improved patient outcomes. Core offerings admit: drug livery technologies (coatings, microparticles, and implants); surface modification coating technologies that impart prurience, prohealing, and biocompatibility capabilities; and components for in vitro diagnostic test kits and specialized surfaces for cell culture and microarrays. Collaborative efforts include a sustained dose delivery system in human trials for treatment of retinal disease and the drug delivery polymer matrix on the first-to-market drug-eluting coronary stent. SurModics is headquartered in Eden Prairie, Minnesota and its Brookwood Pharmaceuticals subsidiary company is set in Birmingham, Alabama. For more information about the company, natter http://www.surmodics.com. The content of SurModics' website is not part of this release or part of any filings the company makes with the SEC.
Safe Harbor for Forward-Looking Statements
This press departure contains innovative statements. Statements that are not historical or stream facts, including statements around beliefs and expectations, ar forward-looking statements. Forward-looking statements involve implicit in risks and uncertainties, and important factors could grounds actual results to differ materially from those hoped-for, including the following: (1) realizing the full potential difference benefits of the company's agreement with Merck & Co., Inc. requires the development of new products and applications of engineering, and the successful management of clinical trials and related extraneous and domestic regulatory processes; (2) costs or difficulties relating to the integration of the businesses of Brookwood Pharmaceuticals and BioFX Laboratories with SurModics' business organisation may be greater than expected and may adversely affect the company's results of operations and financial condition; (3) developments in the regulative environment, as well as market and economic conditions, and our reliance on third parties, may adversely affect our business trading operations and gainfulness, and the company's ability to reach our fiscal 2008 incorporated goals and to realise the voltage of our pipeline; and (4) former factors identified under "Risk Factors" in Part I, Item 1A of our Annual Report on Form 10-K for the financial year concluded September 30, 2007, and updated in our subsequent reports filed with the SEC. These reports are available in the Investors section of our web site at hypertext transfer protocol://www.surmodics.com and at the SEC web site at hypertext transfer protocol://www.securities and Exchange Commission.gov. Forward-looking statements talk only as of the date they are made, and we undertake no obligation to update them in light of new information or future events.
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