Oculus Innovative Sciences, Inc. received European CE Mark for the Microcyn-based GramaDerm Solution and GramaDerm Hydrogel. Both products are intended for use in the topical treatment of mild to moderate acne and are designed to complement other acne treatments.

The new CE Mark was issued by the European notified body, EMKI. The CE Mark is an indication that a medical device complies with the essential requirements of the medical devices directive (93/42/EEC) and that the device has been subjected to conformity assessment procedures. Receipt of the CE Mark will allow Oculus to market and sell the Microcyn-based GramaDerm Solution and GramaDerm Hydrogel in EU member countries that have adopted the medical devices directive without being subject to additional national regulations with regard to demonstration of performance and safety, although  certain EU member countries may request or require additional performance and/or safety data from time to time, on a case-by case basis.

"Securing the CE Mark for our acne products is just the beginning of Oculus' multiple product development initiatives in our continuing European growth strategy," said Bruce Thornton, Oculus executive vice president of international operations. "With CE Mark approval, our EU partnering process has picked up considerably. In addition, we anticipate announcing regulatory approvals and commercialization of other Microcyn-based products, including those for new oral and advanced wound care indications, over the next few quarters."

While a new drug application for Microcyn acne formulation has not yet been filed in the United States, a number of US dermatologists have been using the Microcyn-based atopic dermatitis hydrogel since its introduction in early 2012. As permitted by law, some of these physicians have clinically evaluated the impact of Microcyn in the management of a wide range of dermatological afflictions including acne.

"We've been successfully using a Microcyn-based hydrogel in my clinic for two years," said Dr. Rebecca Smith, a dermatologist at Fort Mill Dermatology in South Carolina. "I have seen promising secondary benefits of Microcyn in the reduction of inflammation and severity of acne outbreaks. In light of the European directive to reduce the use of topical  antibiotics to minimize resistance concerns, European dermatologists will be delighted with the news regarding GramaDerm's approval. We look forward to a similar product approval in the US in the future."

In a study published in the Journal of Dermatological Treatment (April 2009) by Tirado-Sánchez, A. "Efficacy and Tolerance of superoxidized solution in the treatment of mild to moderate inflammatory acne," the Microcyn Technology, upon which the GramaDerm HydroGel is based, outperformed benzyl peroxide (a standard ingredient in many acne treatments) in the reduction of inflammatory lesions as a monotherapy associated with the treatment of acne. At the end of the 12-week study period, the percentage reduction in the number of inflammatory lesions from the initial baseline was 65% in the Microcyn arm versus 54% in the benzyl peroxide arm. The Microcyn product outperformed the benzyl peroxide, the general standard of care, but the difference was not statistically significant. However, the Microcyn technology has not, thus far, demonstrated any bacterial resistance and has an excellent safety profile.