Oculus Innovative Sciences, Inc. (Nasdaq: OCLS), today announced that it has received new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for new dermatology indications for Microcyn® Skin and Wound HydroGel.
Hoji Alimi, founder and CEO of Oculus says specific formulations of Microcyn Technology reduces itch, relieves pain, helps clean infections and hydrates the skin.
"Due to Microcyn Technology¹s reduction of histamine release from mast cells--and thus its reduction of inflammation along with its broad-spectrum antimicrobial nature and its ability to restore the skin barrier, specific formulations are designed to reduce pain and itch related to certain dermal disorders. To date, we have seen a number of case studies supporting the cleared indications."
"There are both Rx and OTC treatments currently available for dermal application, yet it appears that none of these products are meeting the needs of the market. Current Rx products with calcineurin inhibitors are saddled with black box warnings for cancer. Topical steroids present a long-term safety concern. And prescription moisturizers deliver modest efficacy. Nothing available today is both effective and safe. That's why we believe that the market will embrace the new Microcyn HydroGel."
The Rx product, under the supervision of a healthcare professional, Microcyn Skin and Wound HydroGel is intended for management of wounds including itch and pain relief associated with dermal irritation, sores, injuries and ulcers of dermal tissue.
Microcyn-based products, branded as Microcyn Skin and Wound Care and Microcyn Skin & Wound HydroGel in the United States, Microdacyn60™ in Mexico, Dermacyn™ Wound Care in Europe and China and Oxum in India, have treated over two million patients worldwide without a single report of a serious adverse effect.
Noridian Administrative Services LLC, which is the pricing, data analysis and coding contractor for the Medicare program, has assigned Medicare HCPCS code #A6248 to the Microcyn HydroGel.
“We are especially excited to receive our first FDA clearance for the Microcyn HydroGel for dermatology indications including the reduction of itch and pain relief for troublesome skin afflictions,” said Hoji Alimi, founder and CEO of Oculus.
Microcyn HydroGel for dermatology indications will be commercially available in April 2010. Oculus is partnering with a series of independent sales groups in key metropolitan regions with a combined thirty-six person commissioned-based sales team experienced in dermatology, which will focus on the dermatology market including cosmetic and plastic surgeons, pediatricians, aesthetic clinics and dermatologists.
According to a report from Business Insights, in terms of size, the United States market dominates the global dermatology market, responsible for some 41.2% of sales or $4.6 billion in 2005.
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