Oculus Innovative Sciences has enrolled first patient, under an FDA-reviewed protocol, in a clinical study of its Microcyn hydrogel.
Microcyn hydrogel is indicated for use in hypertrophic or keloid scars management.
The double-blind, randomized trial calls for recruitment of up to 40 patients at four different US sites including Albuquerque, New Mexico, High Point, North Carolina, Austin and College Station,Texas.
Oculus will receive an upfront milestone payment from its dermatology partner, AmDerma/Quinnova, at the time of the FDA’s Pre-Market Notification clearance that will reimburse the cost of the trial.
The company said it is expecting to close 40-patient trial and submit the data to FDA within the first half of calendar year 2013.