PETALUMA, Calif., March 14, 2013 (GLOBE NEWSWIRE) -- Oculus Innovative Sciences, Inc. (Nasdaq:OCLS), a commercial healthcare company that designs, produces and markets innovative, safe and effective drugs, devices and nutritional products, including Microcyn® Technology solutions which are used in multiple markets including dermatology, post-surgical, wound care, and animal healthcare, today announced completion of the 112-day follow-up period in the company's clinical trial for the management of hypertrophic or keloid scars. The 40-patient comparative, double-blinded and randomized clinical study was based on an FDA-approved protocol. Patients were enrolled at four different U.S. clinical sites, including Albuquerque, NM, High Point, NC, Austin, TX and College Station, TX.
The company is encouraged by the initial clinical trial results from the management of scars trial and expects to complete data analysis and submit the 510k application to the FDA for review within the next 60 to 90 days. In accordance with FDA regulations, the company expects to release the data immediately after completion of FDA's review. The FDA's standard review time from submission to clearance is ninety days, although industry averages suggest this process can take up to six months.
The trial's primary endpoint was to compare a uniquely formulated Microcyn Technology-based hydrogel versus a dimethicone comparator using the Vancouver Scar Scale that measured vascularity, height/thickness, pliability and pigmentation of scars. There were no direct product-related serious adverse events in either arm reported during the study. Secondary endpoints included the measurements of pain and itch and other reported adverse events and treatment satisfaction as reported by patients through a questionnaire.
"According to a LifeSci Advisors 2012 report, there are currently no FDA-approved pharmaceuticals indicated to reduce scar severity and several available procedure-based and over-the-counter treatments are either invasive, costly or have been reported with limited clinical efficacy or high recurrence rates," said Jim Schutz, CEO of Oculus. "We believe the rapid patient enrollment is indicative of the need for effective and safe management of scars. We remain optimistic about achieving our intended results and upon FDA clearance, anticipate that our U.S. dermatology partner, AmDerma/Quinnova, will launch later in 2013."
AmDerma/Quinnova has agreed to pay Oculus a milestone payment at the time of the FDA pre-market notification clearance that will reimburse Oculus for the cost of this trial.
Scar Treatment Market
According to a 2003 report by Frost & Sullivan, it is estimated that 62 million scars are formed each year in the United States. There are about 93 million people in the United States suffering from scars, out of which about 169 million scars can be characterized as hypertrophic (raised) and keloid (red colored) scars. The raised and red scars market forms the primary target for the scar therapy products. Annually, about 600,000 visits for burns and more than 2.6 million emergency room visits for cut injuries, this forms the potential market for the scar therapy products. The statistics show that out of 6.2 million reconstructive procedures performed on patients in a year, 250,000 surgeries are related with scar revisions.
About AmDerma Pharmaceuticals/Quinnova Pharmaceuticals
AmDerma Pharmaceuticals is a privately held company engaged in the development of pharmaceutical products with dermatological indications. Quinnova Pharmaceuticals, Inc., a wholly owned subsidiary of AmDerma Pharmaceuticals, is a specialty pharmaceutical company founded on innovative, patent-protected dermal delivery technologies. Our 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 our 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, Inc. is a commercial healthcare company that designs, produces and markets innovative, safe and effective drugs, devices and nutritional products. Oculus is pioneering innovative solutions in multiple markets for the dermatology, surgical, wound care and animal healthcare markets, and has commercialized products in the United States, Europe, India, China, 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.
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 "expects," "achieving," and "submit" 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.
Oculus and Microcyn Technology are trademarks or registered trademarks of Oculus Innovative Sciences, Inc. All other trademarks and service marks are the property of their respective owners.
CONTACT: Media and Investor Contact: Oculus Innovative Sciences, Inc. Dan McFadden VP of Public and Investor Relations (425) 753-2105
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