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news.Oculus Innovative Sciences, a specialty pharmaceutical company that develops and markets solutions for the treatment of dermatological conditions and advanced tissue care, has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Alevicyn SG Antipruritic Spray Gel with both prescription and over-the-counter indications.
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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.
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.