FDA Chimes in as Oculus Reportedly Preps Stock Sale

The FDA was asked if Oculus had specific FDA permission to claim that Microcyn has wound-healing benefits for patients with diabetic foot ulcers.

The FDA's response: "No," according to spokesperson Long, adding that, "It is in our [the FDA's] purview to investigate companies which make unsupported claims about drugs or devices." She would not comment about any pending or ongoing FDA investigation involving Oculus.

Oculus did not respond to questions about the FDA's comments on Microcyn, but in its recent 10-K annual report filed with the Securities and Exchange Commission, the company states, "We do not have the necessary regulatory approvals to market Microcyn as a drug in the United States."

At Metro Medical Online, an Internet pharmacy, consumers can buy an 8.5 oz. bottle of Microcyn for $19.95 without a prescription.

According to the Metro Medical Web site, "Microcyn has been studied for its clinical benefits and safety, a number of these findings peer-reviewed and published. These studies demonstrate that the Microcyn Technology delivers wound healing benefits, reduction of inflammation, cure or improvement of infection and antimicrobial activity; all while remaining safe and biocompatible as evidenced in a 2007 study published in the International Wound Journal."

That study examined the effect of Microcyn in laboratory cell cultures, not in humans. And one of the study's investigators, Dr. Andres Gutierrez, was Oculus' Director of Medical Affairs at the time he participated in the study, according to Oculus' SEC filings.

In another company-sponsored phase II study conducted in late 2007, Oculus claimed treatment with Microcyn "cured or improved" 93% of infections in patients with diabetic foot ulcers compared to an infection "cure or improvement" rate of 56% for patients treated with the oral antibiotic levofloxacin.