The approval is based on the completion of randomized trials for use of Microcyn hydrogel in the treatment of acute wounds, diabetic foot care and post-surgical incisions.
Oculus Innovative Sciences sales vice president Bruce Thornton said the randomized trials in China followed by the SFDA approval provides Oculus with a significant business opportunity underwritten by a very strong partner, Shanghai Sunvic.
The approval enables Shanghai Sunvic to market Microcyn hydrogel in both the over-the-counter and professional healthcare markets in China.
Shanghai Sunvic president Water Chang said the company believe that medical community will embrace an anti-infective technology that is proven both safe and effective in treating topical infection.
"We see the SFDA’s rapid approval indicative of a marketplace eager for an anti-infective that works as promised without promoting bacterial resistance as is the case for many of today’s antibiotics," Chang added.
