FDA Clears Oculus’ Scar Management Hydrogel

Dutch wound care company Oculus Innovative Sciences Inc. has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its new Microcyn scar management hydrogel. The Rx product, under the supervision of a healthcare professional, is intended for the management of old and new hypertrophic and keloid scarring resulting from burns, general surgical procedures and trauma wounds. Oculus’ U.S. dermatology partner, Jamison, Pa.-based Quinnova Pharmaceuticals LLC, intends to commercialize the product in the first half of 2014.

“We have known for years that there has been practitioner demand for an efficacious and safe prescription treatment to manage hypertrophic and keloid scarring,” said Jeffrey Day, CEO of Quinnova Pharmaceuticals. “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. The data from the FDA-required study certainly validates the product’s potential in the dermatology space.”

In addition to U.S. commercialization, Oculus is working with its international distributors and partners to bring this new scar product to patients internationally, including through its Latin American partner, More Pharma, with anticipated commercialization in Mexico in 2014. Further product launches should follow shortly after in other Latin American countries as regulatory approvals are secured. In the Asian countries of China, Singapore, Malaysia and India, product launches are anticipated sometime after April 2014. Similarly, the scar product will be introduced in Kuwait, UAE, Jordan and Iraq in the same time frame.

As part of the FDA 510(k) review process, Oculus conducted a double-blind, multi-center randomized clinical study to demonstrate equivalency to a predicate device in scar management. The 40-patient study was conducted at four U.S. investigative sites over 16 weeks, ending March 2013. 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), which assesses scar vascularity, height/thickness, pliability and pigmentation. In addition, subjects evaluated their own pain and itch symptoms.

The VSS total score was calculated for each subject and visit as the sum of the scores reported for each of the three items (vascularity, pliability, and height). According to Oculus, the VSS total score ranged from zero to nine. Individual sign and symptoms were summarized by treatment group. The count and percent of subjects in each category were presented for the VSS items of vascularity, pliability, and height, and for the subject assessment of scar symptoms for pain and itch.

In both the Microcyn hydrogel and the active control groups, the VSS total score reportedly improved consistently at each of the visits. At the end of treatment visit (day 56), the mean VSS total score improvement from baseline was -2.10 in the Microcyn group, versus -1.28 in the control group. At the end of the study visit (day 112), the mean VSS total score improvement was -2.70 in the Microcyn group and -1.83 in the control group. While both groups improved, the reductions were greater in both instances for the Microcyn group.

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.

“We are pleased to receive this scar management 510(k) clearance, which is the eighth FDA approval or clearance for our Microcyn-based products to date,” said Jim Schutz, Oculus’ CEO. “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.”

According to a 2003 report by Frost & Sullivan, it is estimated that 62 million scars are formed each year in the United States. There are about 93 million people in the United States suffering from scars, out of which about 169 million scars can be characterized as hypertrophic (raised) and keloid (red colored) scars. The raised and red scars market forms the primary target for the scar therapy products. Annually, about 600,000 visits for burns and more than 2.6 million emergency room visits for cut injuries, this forms the potential market for the scar therapy products. The statistics show that out of 6.2 million reconstructive procedures performed on patients in a year, 250,000 surgeries are related with scar revisions.

Quinnova Pharmaceuticals, a wholly owned subsidiary of AmDerma LLC, is a specialty pharmaceutical company that makes dermal delivery technologies.