Oculus Sidesteps FDA Rules With Wound Cleaner

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Oculus Innovative Sciences(OCLS Quote) appears to be skirting U.S. drug laws by claiming that its wound-cleansing product containing common diluted bleach has drug-like therapeutic properties.

The Petaluma, Calif.-based company sells Microcyn, a liquid- and gel-based antiseptic sold over the counter for $20 a bottle that is used to clean minor skin abrasions and irrigate or dress more serious wounds like leg and diabetic ulcers.

The U.S. Food and Drug Administration allows Oculus to market Microcyn as a wound cleaner under the agency's regulation of simple medical devices known as 510(k) approvals. Microcyn is similar to numerous other wound-cleaning products sold commercially for years.

Oculus refused to verify the active ingredients in Microcyn.

But Oculus is marketing Microcyn as a drug with specific medical claims that the product cures infections, accelerates wound healing and reduces inflammation in patients with serious diabetic ulcers, according to comments made by the company's CEO Hoji Alimi and CFO Bob Miller on a conference call with investors held on June 11.

Oculus has conducted a single, small phase II study of Microcyn in patients with diabetic foot ulcers, but the company has not followed through with larger, phase III studies required to get the product approved as a wound-healing drug by the FDA.

AUDIO: Listen to Adam Feuerstein and Elizabeth Trotta discuss Oculus

Instead, Oculus CEO Alimi said the company found a "shortened pathway to FDA approval" that would "bypass the proposed $30 million to $40 million cost for the phase III trials in the United States," according to a transcript of the company's June 11 conference call.