Oculus Innovative Sciences Enrolls First Patient in Study of Microcyn Hydrogel in Management of Scars
- Thu, 8/16/12 - 1:40pm
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Oculus Innovative Sciences, Inc. (Petaluma, CA) 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 a US Food and Drug Administration (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 4 different US sites: Albuquerque, NM; High Point, NC; Austin, TX; and College Station, TX.
The data will be submitted to the FDA in support of the 510k application upon completion. The FDA's published key performance index indicates the standard review time from submission to clearance is 90 days, although industry averages suggest this process can take up to 6 months.
Visit www.oculus.com for more information.