SurModics Completes Enrollment of Phase I Clinical Trial of the I-vation(TM) Intravitreal Implant
EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--March 20, 2006--SurModics, Inc. (Nasdaq:SRDX), a leading provider of surface modification and drug delivery technologies to the healthcare industry, announced today the completion of patient enrollment in the STRIDE (Sustained Triamcinolone Release for Inhibition of Diabetic Macular Edema) Phase I Clinical Study. The trial is assessing the safety and tolerability of the I-vation(TM) Intravitreal Implant with triamcinolone acetonide in patients with Diabetic Macular Edema (DME) under an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA).
"Completing Phase I enrollment in our STRIDE clinical trial marks a significant milestone in the development of technologies and therapies for our Ophthalmology Division," said Bruce Barclay, President and CEO of SurModics. "We are particularly pleased with the strong interest expressed by ophthalmology and pharmaceutical companies in identifying ways of delivering drugs in the eye over an extended period of time. We look forward to completing the six-month follow-up and submitting results to the FDA later this year."
The I-vation Intravitreal Implant is a drug delivery system that can deliver a variety of drugs on a sustained release basis for well over a year, can be implanted in a minimally invasive procedure, and may be removed once the drug has been fully released. Currently, the majority of treatments being developed for age-related macular degeneration (AMD) and DME require repeat injections into the eye every one to three months, often with a suboptimal drug dosing profile. Replacing multiple injections with a single implant providing long-term, controlled drug release could represent a significant advance in therapeutic treatment, including improved patient compliance, reduced side effects and greater efficacy.
Eugene de Juan, Jr., M.D., Distinguished Professor of Ophthalmology at University of California, San Francisco, renowned retinal surgeon and an inventor of the I-vation Intravitreal Implant, commented, "The clinical experience with the I-vation Intravitreal Implant in this Phase I trial has been excellent and is a continuing validation of this sustained drug delivery system. The ease of implantation and patient acceptance of the I-vation Intravitreal Implant is very encouraging. This delivery system offers significant benefits over existing therapies for patients with serious retinal conditions such as DME and AMD and for the physicians who treat them. The ability to remove the implant if complications arise offers a significant advantage over alternative implant approaches."
"We are very pleased with the efforts of our principal investigators and their ability to fully enroll this study in such a timely manner," said Paul Lopez, President of the Ophthalmology Division at SurModics. "We believe our progress to date confirms the strong interest in utilizing innovative drug delivery systems to treat serious back of the eye diseases, such as AMD and DME. We will continue to follow these patients as required under our IND protocol with the intent of establishing the long term safety profile of our I-vation Intravitreal Implant. This safety profile will be important for future patients, clinicians and development partners."
The I-vation Intravitreal Implant can be used in combination with drugs developed by other companies to provide sustained release intraocular drug delivery of their drugs. The platform nature of this technology facilitates the use of SurModics' many drug delivery polymer matrix technologies, including the Bravo(TM) polymer matrix, which is currently used on the Cypher(R) Sirolimus-Eluting Coronary stent from Cordis Corporation, a Johnson & Johnson company.
About SurModics, Inc.
SurModics, Inc. is a leading provider of surface modification technologies in the areas of biocompatibility, site-specific drug delivery, biological cell encapsulation, and medical diagnostics. SurModics partners with the world's foremost medical device, pharmaceutical and life science companies to bring innovation together for better patient outcomes. Recent collaborative efforts include the implementation of SurModics' Bravo(TM) drug delivery polymer matrix as a key component of the first-to-market drug-eluting coronary stent and the use of the CELLabration(TM) encapsulation system as an immunoprotective coating for implantable human islet cells. SurModics is also active in the ophthalmology market with the I-vation(TM) Sustained Drug Delivery System, which is currently in human trials for treatment of retinal disease. A significant portion of SurModics' revenue is generated by royalties earned from the sale of our customers' commercial products. SurModics is headquartered in Eden Prairie, MN. More information about the company can be found at www.surmodics.com. The content of SurModics' web site is not part of this release or part of any filings the company makes with the SEC.
Safe Harbor for Forward Looking Statements
Certain statements contained in this press release may be deemed to be forward looking statements under federal securities laws, and SurModics intends that such forward looking statements be subject to the safe harbor created thereby. SurModics does not undertake an obligation to publicly update or revise any forward looking statements, whether as a result of new information, future events or otherwise.
CONTACT: SurModics, Inc.
Phil Ankeny, 952-829-2700
SOURCE: SurModics, Inc.