Medical Device Daily Associate

Taking a new direction from its traditional business model is surface modification and drug delivery technology provider SurModics (Eden Prairie, Minnesota).

The company began its first-ever internalized clinical trial this week, reporting the completion of the initial implants of its I-vation intravitreal implant, one of several technologies it acquired via its January acquisition of ophthalmology drug delivery company InnoRx (Medical Device Daily, Jan. 20, 2005), formerly located in Mobile, Alabama.

“It’s the first time we’ve actually owned the design for a device, if you will,” said Paul Ankeny, SurModics’ CFO and vice president of business development. He told MDD that while ultimately the company intends, as is its traditional model, to license out the technology to other companies that have ophthalmologic drugs and want to deliver them on a sustained basis in the eye, “the difference here is that we believe we can get much better licensing terms having a clinically proven product.”

While the company does not have a lot of experience in putting together clinical trials, Ankeny noted that SurModics had a nearly three-year relationship with InnoRx prior to acquiring that company. “We were integrally involved with the development and then some of the preclinical work,” he said, adding that “by virtue of that, we have great familiarity” with the implant.

Last year, SurModics, best known as the provider of the coating technology used in the Cypher drug-eluting stent from Cordis (Miami Lakes, Florida), invested roughly $3.5 million in InnoRx (MDD, Jan. 28, 2004). Prior to that investment, the companies had established a licensing agreement to develop what became the I-vation, an implantable coil designed to deliver therapeutic agents to the eye to treat various retinal diseases. The product uses SurModics’ site-specific drug delivery technology.

Retinal surgeon and inventor Eugene de Juan Jr., MD, founder of InnoRx, said the first clinical experiences with the I-vation went remarkably well. “For patients with serious retinal conditions such as DME and age-related macular degeneration [AMD], and for the physicians who treat them, this drug delivery system offers enhancements over currently available therapies. The market has confirmed the current need for novel approaches to ocular drug delivery, and I believe SurModics is well positioned to take advantage of this opportunity.”

The implantation procedures are part of a 30-patient, Phase I clinical study assessing the safety and tolerability of the implant in patients with diabetic macular edema (DME) under an investigational new drug application with the FDA. The drug delivery systems were implanted by Herbert Cantrill, MD, and David Williams, MD, retinal surgeons from VitreoRetinal Surgery (Edina, Minnesota).

In a statement, Cantrill said, “It was exciting for the doctors at VitreoRetinal Surgery to perform the first I-vation implant. The implant was easily inserted during a brief outpatient surgical procedure using local anesthesia. Early follow-up has shown the implant to be well tolerated.”

The device, which provides therapy on a sustained release basis for well over a year, can be implanted via a roughly 30-minute in-clinic procedure, rather than an operating room procedure, and may be removed once the drug has been fully released.

Currently, the majority of treatments being developed for AMD and DME require repeat injections into the eye every one to three months, often with a suboptimal drug dosing profile.

The company believes that replacing multiple injections with a single implant, which provides long-term, controlled drug release, could represent a significant advance in therapeutic treatment, including improved patient compliance, reduced side effects and greater efficacy and is the basis for the company’s recently created ophthalmology division.

The InnoRx technology can be used in combination with drugs developed by other companies to offer sustained-release drug-delivery platforms for their drugs. The platform nature of this technology, called the InnoRx Sustained Release System, can utilize one of SurModics’ eight drug delivery polymer matrix technologies, including the Bravo polymer matrix, which is currently used on the Cypher.

SurModics’ initial focus will be to use InnoRx’s technology platform to treat AMD and DME, two back-of-the-eye conditions that are known to be primary causes of blindness. According to industry analysts, these retinal diseases alone affect more than 15 million people in the U.S. and represent a market opportunity projected to reach $2.5 billion to $7 billion within six years.

The company believes the development of the I-vation technology is “very timely” given the growing list of promising drugs for both AMD and DME. Of particular interest in the AMD field, said Ankeny, are such drugs as FDA-approved Macugen, developed by Eyetech Pharmaceuticals (New York) and marketed by Pfizer (New York), as well as a promising new drug called Lucentis, an anti-VEGF compound developed by Genentech (South San Francisco, California).

The company also believes that the implant will be applicable in the treatment of what Ankeny termed “front-of-the-eye diseases” such as glaucoma.

As to a timeline for this feasibility study, Ankeny said the company estimates that it could take up to six months to complete enrollment, with a six-month follow-up before any results are officially reported.

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