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 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 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 www.surmodics.com
and at the SEC website at www.sec.gov.
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
