Positive Phase I for SurModics’ ocular device

SurModics has completed the three year Phase I trial of I-vation TA (triamcinolone acetonide), which uses a novel drug delivery system capable of sustained ocular release of a therapeutic.

The product has been developed to treat patients with diabetic macular edema (DME), a difficult to treat disease that affects the back of the eye.

SurModics’ I-vation technology may be able to provide a superior way of administering drugs to this area, putting it in a strong position in a market that companies including Merck & Co and Pfizer have an interest in.

Pravin Dugel, principal investigator in the trial, said: “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.

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.”

The I-vation system is an intravitreal implant comprising a rigid non-ferrous metallic scaffold coated with SurMedics' Bravo durable polymer matrix, which controls the release of the active drug for periods ranging from six months to two years.

Opportunities in ophthalmology

Current topical, systemic and intraocular delivery methods suffer from limited efficacy due to physiological barriers and potential side effects. Consequently considerable effort has been put into the development of novel drug delivery devices.

SurModics believes it is well placed to meet the demand for more effective and convenient forms of ocular delivery, with its I-vation technology being complemented by an array of other platforms.

Bruce Barclay, SurModics’ president and CEO, said: “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.”