Diabetic foot ulcers occur on the feet of people with type 1 and type 2 diabetes and are usually found on the bottom of the foot. Up to 25% of people with diabetes develop foot problems. Over 80% of leg amputations in the United States are associated with diabetic foot ulcers. The sooner these ulcers are treated, the better the outcome.

Phase II Trial of Microcyn^® Technology in Treatment of Mildly Infected Diabetic Foot Ulcers

Oculus has completed an open-label Phase II clinical trial evaluating its shelf-stable Microcyn Technology in the treatment of mildly infected diabetic foot ulcers. The study, which was conducted at 15 U.S. sites, was specifically designed to identify strong trends relative to the clinical benefits and establish a baseline of safety. This will provide the rationale for larger Phase III trials designed to demonstrate statistically significant safety and efficacy, fundamental in securing NDA marketing approval. Also being examined are a number of other trial parameters for consideration in the design of the larger Phase III trials that will be required for FDA approval. This Phase II trial is now completed and the company released top-line data (see press release) on February 27, 2008 and Clinically Evaluable (CE) population data (see press release) on March 14, 2008 during DFCon 08, one of the world’s premier international diabetic foot conferences.  The clinical success rate at visit 4 (Test of Cure) for Microcyn-alone-treated patients was 93.3% compared to 56.3% for the levofloxacin plus saline-treated patients (p= 0.033).  This study was not statistically powered but the high clinical success rate (93.3%) and the p-value (0.033) would suggest the difference is meaningfully positive for the Microcyn-treated patients.

The trial evaluated three different treatment arms: 1) topical Microcyn alone 2) topical Microcyn in combination with oral levofloxacin; and 3) oral levofloxacin plus topical saline. Each patient received 10 days of treatment with a 14-day follow-up. Designed into the trial were three assessment time points: day 3, day 10, and day 24. This design allows for various options to analyze the data, which will provide important information for the design of the next phase in our clinical program.