PETALUMA, Calif., Aug. 16, 2012 (GLOBE NEWSWIRE) -- Oculus Innovative Sciences, Inc. (Nasdaq:OCLS), today announced it has enrolled the first patients in its double-blind, randomized clinical study evaluating an advanced Microcyn® hydrogel for management of hypertrophic or keloid scars under an FDA-reviewed protocol. The company plans to complete its 40-patient trial and provide top-line data by mid-2013 calendar year. The study design calls for recruitment of up to 40 patients at four different U.S. sites, which are Albuquerque, NM, High Point, NC, Austin, TX and College Station, TX.
"Our dermatology partner, AmDerma/Quinnova, has agreed to pay an upfront milestone payment at the time of the FDA Pre-Market Notification clearance that will reimburse Oculus for the cost of this trial. This, along with their seasoned dermatology sales team, supports our continued business strategy of ramping revenues without increasing overhead. We expect to complete the trial and submit the data to FDA within the first half of calendar year 2013."
Upon completion of the study, the data will be submitted to the FDA in support of the 510k application. The FDA's published key performance index indicates the standard review time from submission to clearance is ninety days, although industry averages suggest this process can take up to six months.Scar Treatment Market According to a 2003 report by Frost & Sullivan, it is estimated that 62 million scars are formed each year in the United States. There are about 93 million people in the United States suffering from scars, out of which about 169 million scars can be characterized as hypertrophic (raised) and keloid (red colored) scars. The raised and red scars market forms the primary target for the scar therapy products. Annually, about 600,000 visits for burns and more than 2.6 million emergency room visits for cut injuries, this forms the potential market for the scar therapy products. The statistics show that out of 6.2 million reconstructive procedures performed on patients in a year, 250,000 surgeries are related with scar revisions.