SurModics I-vation(TM) Intravitreal Implant 36 Month Clinical Study Results Presented at the 2009 ARVO Meeting

May 6, 2009 at 4:01 PM EDT

EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--May. 6, 2009-- SurModics, Inc. (Nasdaq: SRDX), a leading provider of drug delivery and surface modification technologies to the healthcare industry, announced that the 36 month Phase I clinical trial results for I-vation™ TA (triamcinolone acetonide) were presented today by Dr. Pravin Dugel at the 2009 Association for Research in Vision and Ophthalmology (ARVO) Meeting. The primary objective of this study was to evaluate the safety and tolerability of the I-vation TA product in patients with diabetic macular edema (DME). Secondarily, preliminary efficacy was assessed through collection and analysis of retinal thickness and visual acuity data. The 36 month data represents the final patient follow-up required in this phase of the clinical trial.

“These results demonstrate that the I-vation drug delivery system is easily implanted and removed and that the I-vation TA product is safe and well tolerated,” said Pravin Dugel, M.D., Retina Consultants of Arizona, and a Principal Investigator in this I-vation TA clinical trial. “Although this study was not powered to draw any firm conclusions regarding efficacy, results show a significant trend towards early and sustained reduction in macular thickness and a corresponding benefit to visual acuity. I am very encouraged that 71% of patients demonstrated improvement from baseline in visual acuity at their 35 month visit.”

“Our ophthalmology program continues to be an important business driver for SurModics,” said Bruce Barclay, president and CEO. “We are encouraged with the results from our I-vation TA Phase I study and the significant advancements we have made developing this technology. SurModics remains committed to, and confident in, the promising future of our ophthalmology business. We continue to have numerous customer development programs in ophthalmology evaluating several different drug delivery platforms including I-vation, microparticles and biodegradable implants, and have made good progress with each system. We believe ophthalmology will remain a strong contributor to SurModics revenue diversification in the years to come.”

SurModics is currently seeking a global development and commercialization partner for advancement of the I-vation TA sustained delivery product into the next stage of clinical development. The Company possesses an extensive global patent portfolio on the product and has now completed the three year Phase I clinical trial that has shown the I-vation TA product to be safe and well tolerated by patients.

The Phase I trial was the first clinical evaluation of the I-vation sustained drug delivery system evaluating the safety and tolerability of the implant coated with TA in patients with DME. This prospective study was conducted at multiple study centers across the United States, and the 31 subjects were randomized to receive either a slow-release or fast-release formulation of TA. Participants in the study were monitored for 3 years.

About SurModics, Inc.

SurModics’ vision is to extend and improve the lives of patients through technology innovation. The Company partners with the world’s foremost medical device, pharmaceutical and life science companies to develop and commercialize innovative products that result in improved diagnosis and treatment for patients. Core offerings include: drug delivery technologies (coatings, microparticles, nanoparticles, and implants); surface modification coating technologies that impart lubricity, prohealing, and biocompatibility capabilities; and components for in vitro diagnostic test kits and specialized surfaces for cell culture and microarrays. SurModics is headquartered in Eden Prairie, Minnesota and its SurModics Pharmaceuticals subsidiary is located in Birmingham, Alabama. For more information about the Company, visit 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 release contains forward-looking statements. Statements that are not historical or current facts, including statements about beliefs and expectations, such as the future performance of our ophthalmology business or the safety or efficacy of the I-vation TA product are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and important factors could cause actual results to differ materially from those anticipated, including those identified under “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2008, and updated in our subsequent reports filed with the SEC. These reports are available in the Investors section of our website at and at the SEC website at Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update them in light of new information or future events.

Source: SurModics, Inc.

SurModics, Inc.
Phil Ankeny, Senior Vice President and Chief Financial Officer
(952) 829-2700