Oculus Innovative Sciences, Inc. (Nasdaq:OCLS), a specialty pharmaceutical company that develops and markets solutions for the treatment of dermatological conditions and advanced tissue care in 37 countries, today announced the European commercialization of Microcyn(R)-based GramaDerm(TM) Solution and GramaDerm(TM) Hydrogel, approved for use in the topical treatment of mild-to-moderate acne.
"After much planning, we are excited to kick off our commercialization efforts this week of four best-in-class Microcyn-based products for acne, scar management and atopic dermatitis," said Frans Maes, European dermatology sales manager for Oculus. "Our robust clinical evidence of Microcyn's antimicrobial and anti-inflammatory properties bodes well for our new line of dermatology products, especially in light of concerns regarding antimicrobial resistance in acne and the controversial use of corticosteroids in atopic dermatitis. We believe our four new products and strong pipeline of dermatology drug and device candidates will quickly put IntraDerm EU on the radar with healthcare professionals in all 27 EU member countries."
In a study published in the Journal of Dermatological Treatment (April 2009) by Tirado-Sanchez, A. "Efficacy and Tolerance of Superoxidized Solution in the Treatment of Mild to Moderate Inflammatory Acne," Microcyn 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 it tends to have an impeccable safety profile.
"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 availability."
GramaDerm will be marketed under the IntraDerm Pharmaceuticals EU brand, a recently created division of Oculus Innovative Sciences. Four new products, GramaDerm spray and gel, Pediacyn(TM) and Epicyn(TM), will kick off commercial efforts at Medica Trade Fair (http://www.medica-tradefair.com) in Dusseldorf, Germany on November 12-15, 2014.
Overseeing the development and launch of the IntraDerm EU dermatology products in Europe will be dermatology sales manager, Frans Maes. Maes has an extensive background in nursing and more than 15 years of experience in international sales and marketing within various international healthcare companies. To date, Oculus and its European divisions have secured 10 CE Mark approvals for both dermatology and advanced tissue care products.