PETALUMA, Calif., Oct. 9, 2012 (GLOBE NEWSWIRE) -- Oculus Innovative Sciences, Inc. (Nasdaq:OCLS), today announced results of a multicenter, prospective and open-label pilot study in which Microcyn® Technology-based Atrapro™ Antipruritic Hydrogel was evaluated in combination with Neosalus® Cream in the treatment of atopic dermatitis. The two products are frequently marketed as a comprehensive treatment regimen for skin dermatoses including atopic dermatitis.
Oculus licensed the Microcyn Technology-based products for treatment of atopic dermatitis in the United States to Quinnova Pharmaceuticals in February 2011. The lead product, branded as Atrapro™ Antipruritic Hydrogel, was introduced to U.S. dermatologists in February 2012. The Neosalus Cream was commercialized by Quinnova in 2010.
The primary objective of the study, presented in a poster by authors Joseph F. Fowler, Jr, MD, Miriam S. Bettencourt, MD, and Stephen M. Schleicher, MD, at the 2012 Fall Dermatology Conference in Las Vegas this past week, was to evaluate efficacy in providing symptomatic relief among atopic dermatitis patients treated with these two products. A secondary objective evaluated whether the order of product application affected the clinical outcome. Eighteen patients completed the study.
The following assessments were used to evaluate efficacy and symptomatic relief associated with the use of the two products:
- Change in body surface area (BSA) and target lesion area affected with atopic dermatitis from baseline to week 2 and week 4.
- Change in several investigator assessments (ISGA) of the symptoms of atopic dermatitis, measured from baseline to week 2 and week 4.
- Improvement of scores in the patients' evaluation of signs and symptoms of atopic dermatitis; including burning, dryness, pain, itch, and redness.
Patients were directed to apply the cream and the hydrogel sequentially, three times daily to the affected areas of the skin. Patients were assigned randomly into two order-of-application treatment groups: cream first, hydrogel second or the hydrogel first, cream second. The second product was applied immediately after the first product was dry. Patients were evaluated at baseline, week 2, and week 4 (end of treatment).
The clinical results of the study included:
- A statistically significant 50% reduction in the body surface area of the atopic dermatitis from baseline to week 4.
- The symptoms of the disease as assessed by the investigators showed that the majority of the patients at week 4 were clear or almost clear of the disease.
- The severity of the symptoms as indicated by the patients showed an 81% reduction by week 4 from the baseline.
The authors of the study concluded that Neosalus® Cream and Atrapro™ Antipruritic Hydrogel proved to be well-tolerated and effective treatments for patients with atopic dermatitis. Both order-of-application treatment regimens were shown to be effective and safe for patients with atopic dermatitis.
"The new Atrapro Antipruritic Hydrogel, when coupled with the Neosalus Cream, appears to provide a safe and effective one-two punch to mitigate atopic dermatitis," said Rebecca Smith, MD, pediatric dermatologist at Fort Mill Dermatology in South Carolina. "I've experienced this in my practice and now there is further validation as a result of this multicenter study. And just as important as the efficacy is the fact that both these products have excellent safety profiles, allowing me to prescribe this combination therapy without undue concern over adverse side effects."
About Atopic Dermatitis
More than 15 million patients have symptoms of atopic dermatitis, characterized by itchy skin, which can lead to rash, redness, swelling, crusting and scaling. The disease affects up to 20 percent of infants and young children, who continue to have symptoms as adults with significant impact on their quality of life. The exact cause is unknown, but genetics are considered a key factor.
About Quinnova Pharmaceuticals, Inc.
A wholly owned subsidiary of AmDerma, LLC, Quinnova Pharmaceuticals, Inc. is a specialty pharmaceutical company founded on innovative, patent-protected dermal delivery technologies. Quinnova's delivery platforms are utilized to transport safe and effective pharmaceutical ingredients through the epidermis in unique, convenient, and cosmetically elegant formulations. Addressing a wide variety of skin conditions, it is the company's mission to provide superior treatment solutions and product value to clinicians and patients alike. For more information, please visit www.quinnova.com.
About Oculus Innovative Sciences
Oculus Innovative Sciences is a commercial healthcare company that designs, produces and markets innovative, safe and effective healthcare products. Oculus is pioneering innovative solutions in multiple markets including dermatology, surgical, wound care, animal healthcare and others, and has commercialized products in the United States, Europe, India, China and Mexico and select Middle East countries. The company's headquarters are in Petaluma, California, with manufacturing operations in the United States and Latin America. More information can be found at www.oculusis.com.
Forward-Looking Statements
Except for historical information herein, matters set forth in this press release are forward-looking within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including statements about the Company's commercial and technology progress and future financial performance. These forward-looking statements are identified by the use of words such as "provide," "appears" and "allowing," among others. Forward-looking statements in this press release are subject to certain risks and uncertainties inherent in the Company's business that could cause actual results to vary, including such risks that regulatory clinical and guideline developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, protection offered by the Company's patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company's products will not be as large as expected, the Company's products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, the Company may not meet its future capital needs, and its ability to obtain additional funding, as well as uncertainties relative to varying product formulations and a multitude of diverse regulatory and marketing requirements in different countries and municipalities, and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission including the annual report on Form 10-K for the year ended March 31, 2012. Oculus Innovative Sciences disclaims any obligation to update these forward-looking statements except as required by law.
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