Oculus Innovative Announces Addnl. Positive Mid-stage Trial Results For Microcyn Technology In Mildly Infected Diabetic Foot Ulcers - Quick Facts

(RTTNews) - Friday, Oculus Innovative Sciences, Inc. (OCLS | news | PowerRating | PR Charts ) reported additional positive results from its U.S. Phase II clinical trial evaluating Microcyn Technology as a topical antimicrobial treatment for mildly infected diabetic foot ulcers.

In the clinically evaluable population of the study, the clinical success rate at visit 3, i.e end of therapy, for Microcyn-alone-treated patients was 77.8% compared to 61.1% for the levofloxacin plus saline treated patients.

The clinical success rate at visit 4, Test of Cure, for Microcyn-alone-treated patients increased to 93.3% compared to 56.3% for the levofloxacin plus saline-treated patients. This study was not statistically powered but the high clinical success rate of 93.3% and the p-value of 0.033 would suggest the difference is meaningfully positive for the Microcyn-treated patients, the company said.

Hoji Alimi, CEO and founder of Oculus Innovative Sciences, said, "This additional data reaffirms our belief that Microcyn has the potential to be a benefit to patients with infected diabetic foot ulcers."

Oculus Innovative plans to request an end-of-Phase II meeting with the FDA to discuss Phase II results and define the scope and parameters for advancing the clinical program to a New Drug Application.

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