The study is designed to recruit 40 patients at four different US sites and provide top-line data by mid-2013 calendar year.
Oculus Innovative’s dermatology partner, AmDerma/Quinnova, has agreed to pay an upfront milestone payment at the time of the FDA Pre-Market Notification clearance that will reimburse Oculus for the cost of this trial.
Upon completion of the study, the data will be submitted to the FDA in support of the 510k application, according to the company.
According to a 2003 report by Frost & Sullivan, it is estimated that 62 million scars are formed each year in the US.