PETALUMA, Calif., June 8, 2015 (GLOBE NEWSWIRE) -- Oculus Innovative Sciences, Inc. (Nasdaq:OCLS), a specialty pharmaceutical company that develops and markets solutions for the treatment of dermatological conditions and advanced tissue care, today announced that it has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company’s new Alevicyn SG Antipruritic Spray Gel with both prescription and over-the-counter indications. Produced using the patented Microcyn® Technology, The Alevicyn SG prescription product, under the supervision of a healthcare professional, is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis and atopic dermatitis. It may also be used to relieve the pain of first- and second-degree burns and helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
In the United States, Alevicyn SG will launch in July 2015, via Oculus’ direct dermatology sales force. Outside the United States, Oculus is working with its international distributors and partners to bring this novel technology to dermatology patients around the world.
In tandem with the prescription clearance, the Alevicyn SG Antipruritic Spray Gel has also been cleared for over-the-counter use in the United States. In this use, it is intended to relieve the burning and itching associated with many common types of skin irritation, lacerations, abrasions, and minor burns and is also indicated for the management of irritation and pain from minor burns, including sunburn. For more information, visit www.intraderm.com.
About Atopic Dermatitis
In a 2009 GlobalData study, it was estimated the global atopic dermatitis therapeutics market delivered revenues of $643 million in 2009. It is expected to grow to $810 million at a Compound Annual Growth Rate (CAGR) of 3.4% by 2016. Globally, the United States remains the largest market for atopic dermatitis therapeutics, and generated revenue of $402 million in 2009. It is forecast to grow at a CAGR of 3.8% over the next seven years to reach $582 million by 2016.
Symptoms of atopic dermatitis are 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.
Topical corticosteroids (such as hydrocortisone, betamethasone, and fluticasone) are the most common treatment for atopic dermatitis. As eczema tends to be persistent, most people will have to use topical steroids on and off for many years. If used continuously, topical steroids may lose their effectiveness after a few weeks. This is known as tachyphylaxis.
About IntraDerm Pharmaceuticals
A division of Oculus Innovative Sciences, IntraDerm Pharmaceuticals is a global dermatology enterprise with an initial focus on Microcyn-based dermatology products. The division’s headquarters are in Petaluma, California with sales operations also in the Netherlands, and manufacturing operations in the United States and Latin America. More information can be found at www.intraderm.com.
About Oculus Innovative Sciences, Inc.
Oculus Innovative Sciences is a specialty pharmaceutical company that develops and markets solutions for the treatment of dermatological conditions and advanced tissue care. The company’s products, which are sold throughout the United States and internationally, have improved outcomes for more than five million patients globally by reducing infections, itch, pain, scarring and harmful inflammatory responses. The company’s headquarters are in Petaluma, California, with manufacturing operations in the United States and Latin America. European marketing and sales are headquartered in Roermond, Netherlands. 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 commercial and technology progress and future financial performance of Oculus Innovative Sciences, Inc. and its subsidiaries (the “Company”). These forward-looking statements are identified by the use of words such as “bring,” “working,” and “launch,” 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 common stock and warrants may be delisted from NASDAQ, 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, the Company may not be able 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 its annual report on Form 10-K for the year ended March 31, 2014. The Company disclaims any obligation to update these forward-looking statements, except as required by law.
Oculus®, Microcyn® Technology and IntraDerm Pharmaceuticals™ 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 dmcfadden@oculusis.com
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