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news.Oculus Innovative Sciences has finalized a unique proprietary formulation with antimicrobial claims that allows for immediate marketing of this product in the US within a specific medical market without the need for pre-approval by the FDA.
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The company is pursuing patent protection on this unique formulation. Outside the US, the company is moving rapidly to secure regulatory approvals, if needed, in those regions where the original Microcyn Technology formulation is already commercialized, which includes India, Europe, Mexico, and soon China.
While clinical studies are not required for commercialization in the US, the company will sponsor a number of studies to be used for marketing purposes for these novel formulations.
Jim Schutz, vice president of corporate development at Oculus, said: “We are exploring various partnerships and commercialization opportunities with these new and innovative formulas. We plan to market these products both domestically and via our partners outside of the US.”