PETALUMA, Calif., Mar 13, 2007 (BUSINESS WIRE) -- Oculus Innovative Sciences, Inc. (NASDAQ:OCLS) announced publication of results from a non-randomized study of its Dermacyn® Wound Care (DWC) product, conducted in Italy for the treatment of wide post-surgical infected diabetic foot ulcers. The results were published in the current issue of International Journal of Lower Extremity Wounds and a reprint of the submission can be viewed online at: http://www.oculusis.com/europe/study.pdf.
Researchers at the University of Pisa, Italy, used an experimental study design comparing 33 patients with diabetes who had post surgical lesions greater than 5 square centimeters without ischemia. Eighteen patients were treated with Dermacyn while a 15 patient historical control group was treated with diluted povidone iodine. All patients were treated with standard of care including antibiotic therapy and local surgical debridement. Patients received weekly assessment. At baseline, there were no significant differences between the two groups in the number of minor amputations and in the number of revascularizations.
The study results indicated that patients treated with Dermacyn in combination with antibiotics had a significant decrease in healing time and duration of antibiotic therapy, and experienced a higher healing rate at six months compared with the group treated with diluted povidone iodine in combination with antibiotics (p less than 0.01). Further results exhibited in the Dermacyn-treated arm included a significant decrease in recurrence of infection, a requirement for additional debridement procedures, along with the need for fewer amputations during the Dermacyn group's follow-up period (p less than 0.05). No adverse events were reported in the Dermacyn group, although one patient in the iodine group withdrew due to topical dermatitis.
At the end of study's follow-up, the frequency of minor amputations was significantly higher in the iodine group compared to the Dermacyn group; healing times were significantly faster in the Dermacyn group (p=.00361); and the proportion of patients healed in six months was significantly higher in the Dermacyn group (p=0.00827). In addition, the duration of antibiotic therapy was shorter for the Dermacyn group than the iodine group (p=0.01373). Also, the incidence of re-infection was significantly less in the Dermacyn group (p=0.0154). Finally, the Dermacyn group had significantly fewer surgical debridement procedures during follow-up (p=0.00121).
The researchers summarized that these preliminary data suggest that DWC, used as a wound dressing together with other local and systemic therapies, may have a role in reducing healing time as well as complications in patients with diabetes who have post-surgical lesions of the diabetic foot. These data, they indicated, propose the need for a robust controlled study of DWC-saturated dressings to explore its full potential. They also noted that the results from this small study show that DWC was more effective than povidone iodine in treating wide post-surgical wounds of the diabetic foot and promoting healing. However, there were no differences in safety between these two treatments. The researchers indicate that one limitation of this study is its non-randomized design.
Hoji Alimi, president and CEO of Oculus, commented, "The independent study results published in The Journal of Lower Extremity Wounds are consistent with earlier human study results across a spectrum of Dermacyn studies. Similarly, we are in the process of initiating a Phase 2 clinical trial of Dermacyn in diabetic foot ulcer infections. The Phase 2 study is the first in the U.S. clinical development plan that we have previously discussed which could lead to a NDA filing in early 2009."
About Diabetic Foot Ulcers
The Centers for Disease Control and Prevention (CDC) estimates that there are over 1.5 million new cases of diabetes diagnosed annually, and that the overall disease affects roughly 7% of the U.S. population, or 20.8 million people. Foot ulcers are a common complication of diabetes, accounting for high morbidity and mortality, with an estimated 15% of diabetic patients expected to develop a lower extremity ulcer during the course of their disease.
Oculus Innovative Sciences is a publicly traded, emerging specialty pharmaceutical company that develops, manufactures and markets a family of Microcyn® Technology-based products intended to help prevent and treat infections in chronic and acute wounds. Oculus' platform technology, called Microcyn®, is a non-irritating, super-oxidized, water-based solution that is designed to treat a wide range of pathogens, including antibiotic-resistant strains of bacteria, as well as viruses, fungi and spores.
Oculus' principal operations are in Petaluma, California, and it conducts operations in Europe and Latin America through its wholly-owned subsidiaries, Oculus Innovative Sciences Netherlands B.V. and Oculus Technologies of Mexico, S.A. de C.V. Our website is www.oculusis.com.
Certain statements in this press release are forward-looking pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These may be identified by the use of forward-looking words or phrases such as "believe," "could lead," and "should," among others. These forward-looking statements are based on Oculus Innovative Sciences, Inc.'s current expectations. Investors are cautioned that such forward-looking statements in this press release are subject to certain risks and uncertainties inherent in the Company's business, including, but not limited to: (1) risks inherent in the development and commercialization of potential products; (2) the Company's unproven ability to discover, develop, or commercialize proprietary drug candidates; (3) the risk that clinical studies or trials of products that the Company does discover and develop will not proceed as anticipated or may not be successful, or that such products will not receive required regulatory clearances or approvals; (4) the uncertainty that the Company's products will be accepted and adopted by the market, including the risk that these products will not be competitive with products offered by other companies, or that users will not be entitled to receive adequate reimbursement for these products from third-party payors such as private insurance companies and government insurance plans; (5) the Company's future capital needs; (6) the Company's ability to obtain additional funding; (7) the ability of the Company to protect its intellectual property rights and to not infringe the intellectual property rights of others; (8) and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Oculus' periodic reports, including the quarterly report on Form 10-Q for the quarter ended December 31, 2006.
Oculus, Dermacyn® and Microcyn® are trademarks or registered trademarks of Oculus Innovative Sciences, Inc. All other trademarks and services marks are the property of their respective owners.
SOURCE: Oculus Innovative Sciences, Inc.
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