Oculus Innovative Sciences (OCLS) (warrants OCLSW), 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 Microcyn®-based SebDerm Gel.
As a prescription product, SebDerm Gel is intended to manage and relieve the burning, itching, erythema, scaling, and pain experienced with seborrhea and seborrheic dermatitis. It also helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Zoe Draelos, MD and president of Dermatology Consulting Services in High Point, North Carolina, commented, "Seborrheic dermatitis is a common condition afflicting men and women of all ages that is challenging for dermatologists to treat.
While treatment options exist, recurrence is common and few options exist for disease maintenance. A new addition to the dermatologist’s armamentarium, such as the Microcyn technology, will be welcome."
In addition to U.S. commercialization, which is planned for the quarter ending June 30, 2016, via IntraDerm’s 19-person direct sales team, Oculus is working with its international distributors and partners to bring this advanced technology to dermatology patients throughout the globe, including Asia and the Middle East.
"Our new Microcyn-based SebDerm gel adds a valuable tool to the dermatologist’s bag when it comes to combatting both seborrhea and seborrheic dermatitis," said Jeffrey Day, president of IntraDerm Pharmaceuticals, Oculus’ dermatology division.
"Nearly a quarter of the general population is afflicted with seborrheic dermatitis, thus a solution that resolves this ubiquitous skin disease is anticipated to be widely embraced."