Businessweek

Oculus Innovative Sciences, Inc. announced new regulatory approvals for Microcyn(R)-based antiseptic products, under the brand name Microdacyn(R), in Panama and El Salvador. Oculus' Latin American partner, More Pharma, intends to begin commercialization of these new antiseptic products in both countries in the summer of 2013.

Oculus Innovative Sciences, Inc. announced new regulatory approvals in Dubai, United Arab Emirates, Kuwait, and Iraq for three new Microcyn(R)-based consumer products: Face Cool(TM), a hydrogel for the treatment of acne and various dermatoses; Baby Cool(TM), a hydrogel for treatment of baby rash; and Lady Cool(TM), a feminine hygiene wash. All products are targeted to be launched in the fall of 2013.

Oculus Innovative Sciences, Inc. announced that the company's partner in that region, Dyamed Biotech Pte. Ltd, is initiating rollout of 5 new Microcyn(R) Technology-based products in Singapore and Malaysia, both in the hospital and consumer markets. The five products, which include Dermacyn(TM) BabyGuard, Dermacyn DermaGuard, Dermacyn SkinGuard Solution, Dermacyn SkinGuard Hydrogel and Dermacyn Wound Care Hydrogel, will be rolled out sequentially with all products commercialized by year's end.

Oculus Innovative Sciences, Inc. announced the issuance of three new international patents for the company's technology, Microcyn(R). These include a Chinese patent for treatment of second- and third-degree burns, and two Mexican patents, the first for treatment of skin ulcers and the second for treatment of second- and third-degree burns as well. The latest-issued patents join an intellectual property estate (either owned or licensed to Oculus) that now includes 35 issued patents (five in the United States, 12 registered in the E.U., and 18 other foreign patents) as well 109 pending applications (including U.S. provisional applications) directed to chemical compositions, apparatuses, methods of manufacturing and therapeutic uses.

Oculus Innovative Sciences, Inc. announced completion of the 112-day follow-up period in the company's clinical trial for the management of hypertrophic or keloid scars. The 40-patient comparative, double-blinded and randomized clinical study was based on an FDA-approved protocol. Patients were enrolled at four different U.S. clinical sites, including Albuquerque, NM, High Point, NC, Austin, TX and College Station, TX. The company is encouraged by the initial clinical trial results from the management of scars trial and expects to complete data analysis and submit the 510k application to the FDA for review within the next 60 to 90 days. In accordance with FDA regulations, the company expects to release the data immediately after completion of FDA's review. The FDA's standard review time from submission to clearance is ninety days, although industry averages suggest this process can take up to six months. The trial's primary endpoint was to compare a uniquely formulated Microcyn Technology-based hydrogel versus a dimethicone comparator using the Vancouver Scar Scale that measured vascularity, height/thickness, pliability and pigmentation of scars. There were no direct product-related serious adverse events in either arm reported during the study. Secondary endpoints included the measurements of pain and itch and other reported adverse events and treatment satisfaction as reported by patients through a questionnaire.