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Oculus receives European CE mark for new microcyn-based atopic dermatitis Hydrogel

Oculus Innovative Sciences announced the issuance of a new CE Mark in Europe for microcyn-based Pediacyn Hydrogel.

Pediacyn Hydrogel is indicated for the care of lesions associated with atopic dermatitis by assisting with moistening while forming a protective barrier against physical, chemical and microbial invasion of the atopic dermatitis lesions.

Bruce Thornton, Oculus senior vice president for international operations said: "We have seen the successful adoption in the United States of our various Microcyn-based atopic dermatitis products with over 100,000 prescriptions written. The clinical evidence confirming Microcyn’s efficacy in the treatment of atopic dermatitis is highly compelling. Following our European introduction, we look forward to offering our partners in the Middle East, Asia and India this exciting new offering as well with significant supporting clinical data in six U.S. clinical studies or posters that collectively demonstrate rapid reduction of itch and improvement in the rash."

In October 2012, Oculus announced the results of a multicenter, prospective pilot study in which a Microcyn-based antipruritic hydrogel was evaluated in combination with a non-comedogenic water-soluble cream dressing.

The primary objective of the study, presented in a poster by authors Joseph F. Fowler, Jr, MD, Miriam S. Bettencourt, MD, and Stephen M. Schleicher, MD, was to evaluate efficacy in providing symptomatic relief among atopic dermatitis patients treated with these two products. A secondary objective evaluated whether the order of product application affected the clinical outcome. Eighteen patients completed the study.

The following assessments were used to evaluate efficacy and symptomatic relief associated with the use of the two products:
Change in body surface area (BSA) and target lesion area affected with atopic dermatitis from baseline to week 2 and week 4.
Change in several investigator assessments (ISGA) of the symptoms of atopic dermatitis, measured from baseline to week 2 and week 4.

Improvement of scores in the patients’ evaluation of signs and symptoms of atopic dermatitis; including burning, dryness, pain, itch, and redness.