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FDA grants 510(k) clearance for SebDerm Gel for seborrheic dermatitis
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Oculus Innovative Sciences announced in a press release that the FDA has granted 510(k) clearance for it Microcyn-based SebDermGel to treat seborrheic dermatitis.
“Seborrheic dermatitis is a common condition affecting men and women of all ages that is challenging for dermatologists to treat,” Zoe Draelos, MD, president of Dermatology Counseling Services in High Point, North Carolina, state in the release. “While treatment options exist and new options exist for disease maintenance. A new addition to the dermatologist’s armamentarium, such as Microcyn technology, will be welcome.”
Microcyn technology includes hypochlorous acid, which has been shown in studies to destroy bacteria, viruses, spores, and fungi, according to the release
An estimated 25% of the population has seborrheic dermatitis. SebDerm Gels helps to relieve symptoms includes burning, itching, erythema, scaling and pain, according to the release. It also maintains a moist wound and skin environment in the healing process, relieving dry, waxy skin, the release reported.
Oculus plans to begin U.S. commercialization of the product in the quarter ending June 30, 2016, using the direct sales team of IntraDerm Pharmaceutics, a division of Oculus, according to the release.
Reference: www.oculusis.com