Oculus Innovative Sciences : Chinese SFDA Regulatory Approval of Microcyn Technology

Mar 27, 2008 - Oculus Innovative Sciences, Inc. (NASDAQ:OCLS) announced that the Chinese State Food and Drug Administration (SFDA) has approved Microcyn® Technology for use in China. The Chinese agency approved Microcyn Technology for treatment of various acute and chronic wounds including ulcers, cuts, contusions and burns. This approval allows Oculus' Chinese partner to market Microcyn Technology as a technology that provides a moist environment for wounds and accelerates wound healing through the reduction of microorganisms in wounds.
This approval follows the completion and submission of two randomized controlled Chinese clinical trials of Microcyn in December of 2007--a burn wound study with 162 patients and a chronic wound treatment study with 35 patients. The Microcyn Technology will be marketed by Oculus' Chinese partner, China Bao Tai... Oculus Innovative Sciences' Press Release -

Oculus Innovative Sciences, Phase II Data with Microcyn® Technology in Mildly Infected Diabetic Foot Ulcers

Feb 27, 2008 - Oculus Innovative Sciences, Inc. (Nasdaq:OCLS) announced positive top-line results from its U.S. Phase II clinical trial evaluating Microcyn® Technology as a topical antimicrobial treatment for mildly infected diabetic foot ulcers. Microcyn demonstrated a positive clinical response, defined as the clinical cure or improvement of infection, as a monotherapy and in combination with levofloxacin, a systemic antibiotic. The company 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... Oculus Innovative Sciences' Press Release -

Oculus Innovative Sciences, Phase II Study for Microcyn(R) Technology in Mildly Infected Diabetic Foot Ulcers

Sep 17, 2007 -Oculus Innovative Sciences, Inc. (NASDAQ:OCLS) announced that it held an investigator meeting yesterday at the Interscience Conference on Antimicrobial Agents and Chemotherapy in Chicago...Sixteen medical centers and clinics across the United States are participating in the current Phase II trial, which is a 60-patient, randomized and open-label Phase II study to evaluate the preliminary safety and efficacy of topical Microcyn(R) Technology for the treatment of mildly infected diabetic foot infections... Oculus Innovative Sciences' Press Release -