US-based developer of wound care devices Oculus Innovative Sciences has obtained a new 510(k) clearance from the US Food and Drug Administration (FDA) for its new Microcyn scar management hydrogel.
The Rx product, under the supervision of a physician, is intended for the management of old and new hypertrophic and keloid scarring resulting from burns, general surgical procedures and trauma wounds.
As part of the FDA 510(k) review process, Oculus conducted a 40-patient comparative, double-blinded and randomised clinical study to demonstrate equivalency to a predicate device in scar management.
The study was conducted at four US investigative sites over 112-days, ending in March and the qualified scars included linear or widespread hypertrophic or keloid scars. The age of target scars ranged between three months and one year.
Investigators evaluated the qualified scar using the Vancouver Scar Scale (VSS) that measured vascularity, thickness, pliability and pigmentation of scars, while pain and itch symptoms were evaluated by the subjects.
In both the Microcyn HydroGel and the active control groups, the VSS total score improved consistently at each of the visits.
Individual signs and symptoms scores were evaluated throughout the study, which included improvement in itch and pain. The reductions from baseline in the mean individual signs and symptoms scores were greater in the Microcyn group.
Oculus CEO Jim Schutz said: "We believe that Quinnova's dermatology sales and marketing expertise, and our strong supporting clinical data for this new product, is a winning combination for doctors and their patients.
"We look forward to sharing this new FDA clearance with our international partners to make this great product available outside the United States as soon as we clear international regulatory hurdles."
In the US, the product will be commercialised by the company's partner, Quinnova Pharmaceuticals in the first half of 2014, while Latin American partner, More Pharma, will commercialise in Mexico in 2014.
The scar product will be introduced in the Asian countries of China, Singapore, Malaysia, India and the Middle East countries of Kuwait, UAE, Jordan and Iraq sometime after April 2014.
Quinnova Pharmaceuticals CEO Jeffrey Day said the company has known for years that there has been practitioner demand for an efficacious and safe prescription treatment to manage hypertrophic and keloid scarring.
"Having seen first hand the compelling impact that our Microcyn-based technology products have had on the management of conditions such as atopic dermatitis, we are equally excited about its potential as well in managing scars," Day added.
"The data from the FDA-required study certainly validates the product's potential in the dermatology space."
According to GlobalData estimates, the US hydrogels market was valued at $37.8m in 2012 and is expected to grow at a CAGR of 3.6% to reach $48.4m by 2019.