FDA Chimes in as Oculus Reportedly Preps Stock Sale

The company announced results from this study in February 2008 and again in March 2008.

However, the positive result announced by Oculus was not the primary endpoint of the study and was derived from a smaller subset of the total patients enrolled.

The actual results of the study, which only enrolled 66 patients with mildly infected diabetic foot ulcers, showed that treatment with Microcyn alone did not lead to a statistically significant difference in "cure or improvement" of infection compared to levofloxacin plus saline or the combination of levofloxacin and Microcyn.

Moreover, Microcyn is not an approved or recommended treatment for infected diabetic foot ulcers, according to the official treatment guidelines of the Infectious Disease Society of America (IDSA).

Oculus did not respond to questions about the Microcyn studies. The company's 10-K states, "Most of these studies were not intended to be rigorously designed or controlled clinical trials and, as such, did not have all of the controls required for clinical trials used to support a new drug application, or NDA, submission to the FDA."

Meantime, Oculus is in danger of running of cash, which is why Oculus and its banker Dawson James are working to line up investors to buy into a new stock offering of 1.2 million shares and 600,000 warrants, according to a person familiar with the company's plans.

Oculus spokesman Dan McFadden would neither confirm nor deny the imminent stock sale. Oculus filed an amended registration statement for the new stock and warrants with the SEC last week. The company cannot sell the shares until the SEC deems the registration statement effective.