The trial data has been submitted to the Chinese State Food and Drug Administration (SFDA) as the final step in securing agency approval to market Microcyn-based products in China.
The first 162-patient burn wound study was designed to demonstrate both Microcyn’s safety and efficacy in healing second-degree and above burns. The second trial was a randomized, controlled 35-patient clinical trial designed to demonstrate both Microcyn’s safety and efficacy in healing chronic wounds, which include diabetic foot ulcers, radiation ulcers and venous leg ulcers.
Hoji Alimi, chairman and CEO of Oculus Innovative Sciences, said: “We are pleased to report our Chinese partner’s completion of the Microcyn trials in both burn and chronic wounds, and its submission for SFDA approval. This is in full alignment with our strategy to expand access to Microcyn globally through our various partners. We are confident that these randomized and controlled studies will again validate the already positive results we have seen to date in 20 clinical studies in over 700 patients worldwide.”