Oculus Innovative Sciences receives US FDA approval for new Microcyn-based Lasercyn Gel
Oculus Innovative Sciences, Inc., a specialty pharmaceutical company, announced it has received a new 510(k) clearance from the US Food and Drug Administration (FDA) for the company's new Microcyn-based Lasercyn Gel.
Under the supervision of a healthcare professional, Lasercyn Gel is intended for the management of post-non-ablative laser therapy procedures, post-microdermabrasion therapy and following superficial chemical peels. Lasercyn may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns.
Dr. Michael Gold, board-certified dermatologist and cosmetic surgeon, and founder of Gold Skin Care Center, Advanced Aesthetics Medical Spa, The Laser & Rejuvenation Center, and Tennessee Clinical Research Center, all located in Nashville, Tennessee, commented, "Lasercyn is a promising new tool for all aesthetic dermatologists who are looking to better manage post-laser itch and pain associated with laser skin resurfacing, along with enhanced healing. In our clinical testing of Lasercyn to date, we have seen dramatically improved outcomes with quicker healing times and less patient discomfort when Lasercyn is added to the post-procedure management protocol."
Oculus will begin marketing Lasercyn via its own US dermatology sales team beginning in the summer of 2016.
According to the Clinical, Cosmetic and Investigational Dermatology Journal, medical and aesthetic skin procedures have seen a steady surge within the last decade, and a higher demand for skin rejuvenation practices. In 2013 in the United States, dermatologic surgeons performed over 9.5 million treatments, an almost 22 per cent increase from the previous year, with a rising number of treatments involving skin resurfacing in the areas of laser/light/energy-based procedures (2.25 million), chemical peels (1.1 million), and microdermabrasion (974,000).
Laser skin resurfacing, also known as a laser peel, laser vaporization and lasabrasion, can reduce facial wrinkles, scars and blemishes. Newer laser technologies provide surgeons with a new level of control in laser surfacing, permitting extreme precision, especially in delicate areas. The laser beam used in laser resurfacing will remove outer layer of skin, called the epidermis. It simultaneously heats the underlying skin, called the dermis. This action works to stimulate growth of new collagen fibers. As the treated area heals, the new skin that forms is smoother and firmer.
Common side effects include redness of the skin, swelling of the treated area, itch, pain and moderate irritation similar to the feeling produced by a mild sunburn.