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Oculus’ Microcyn over FDA hurdle

WOUND TREATMENT EXCEEDS EXPECTATIONS IN SMALL PHASE II TRIAL

PETALUMA – The wound-care solution Microcyn made by Oculus Innovative Sciences aced its FDA Phase II trials, giving the company’s staff a big boost and further demonstrating the product is effective in treating mildly infected diabetic foot ulcers.

“We have clear proof that our technology works,” said Oculus founder and CEO Hoji Alimi. “And the product performed beyond our expectations.”

Microcyn was tested alongside the current leading therapy for infected diabetic foot ulcers, in this case the orally administered antibiotic Levofloxacin.

Microcyn is a shelf-stable oxychorine compound intended to help prevent and treat infections in chronic and acute wounds through its antibacterial properties. It’s used directly on the wound.

In addition, unlike other anti-infectives, studies show that the technology also promotes wound healing through increased blood flow to the site and reduction of inflammation.

Sixty-six patients at 15 sites were treated for 10 days with Microcyn alone, Levofloxacin with a cleansing saline solution, and Levofloxacin and Microcyn together.

Microcyn alone had a cure or improvement rate of 75 percent compared with a 57 percent cure or improvement rate for Levofloxacin and saline.

“More importantly, that rate held for the follow-up period two weeks later, while the Levofloxacin rate dropped to 52 percent,” said Mr. Alimi.

He emphasized that this was not a study to demonstrate superiority of Microcyn over another product. But if the numbers hold true for the larger statistical trials of Phase III, Microcyn could prove to be a more effective form of treatment than has yet been approved.

On Friday, March 14, Oculus will present the expanded Phase II findings, along with the results of two confirmatory trials in Italy and India, at the DFCon 2008 in Los Angeles, one of the premier international diabetic foot conferences.

In mid-2008, the company will sit down with FDA scientists to design the next phase of its U.S. clinical program, which may look for a repeat of what was demonstrated during Phase II using a far larger population group, or may seek to demonstrate Microcyn’s superiority to a product or products currently in use.

“The FDA decides, and they also determine the size of the study, its breadth and its methodology,” said Mr. Alimi. “It’s foolhardy to proceed without the guidance of the FDA because even if you obtain the results they are looking for, they might object to your methods.”

Oculus is taking no chances because its product could represent a major step forward in the treatment of a condition that affects a growing number of Americans – one in three born in 2000 –who will develop diabetes in their lifetimes.

Diabetic ulcers, common where the circulation to extremities is affected, are costly and difficult to treat because the more severe the infection, the more difficult it is to reach with oral antibiotics.

The average cost of treatment for a single ulcer is currently about $8,000, $17,000 for an infected ulcer and $45,000 for an ulcer requiring amputation. In the U.S., more than 80,000 such amputations are performed each year.

“These figures, including high rates of second amputations and mortality following them, haven’t changed much in the past 30 years, despite huge advances in the medical and surgical treatment of patients with diabetes,” said Mr. Alimi.

Microcyn, if it proves itself equally effective as oral antibiotics in treating infected diabetic ulcers, will save the patient from side effects caused by the numerous chemicals that enter the system with oral medicines, he pointed out.

For more information, visit www

.oculusis.com.

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