California-based Suneva Medical has stated that, pending the completion of its clinical study, it plans to submit a supplemental PMA for its dermal filler, ArteFill, to the FDA for consideration of an expanded indication in acne scarring.
The company is in the latter stages of conducting a comprehensive study aimed at validating the efficacy and safety of the filler in treating acne scarring. The study involves 10 leading principle investigators located throughout the United States.
The filler study enrolled more than 130 individuals, using both men and women of all skin types to assess the results of the treatment on different types of skin and degrees of acne scarring.
Acne scarring is a widespread issue in the US
“What we are targeting is the fact that acne scarring is much more widespread than anyone thinks, estimates from the American Academy of Dermatology suggest that up to 20 million people in the United States may be currently affected by the condition. While we don’t know exactly how many of them will need this kind of treatment, we believe there are a significant number of patients out there who will benefit,” said Dr. Jwala Karnik, Chief Medical Officer at Suneva Medical.
“Acne scars have a physical and emotional impact that goes beyond just the appearance of the scar. Once the 12 month data is complete, we will submit the appropriate documentation to the FDA for review.
ArteFill is currently FDA-approved for the treatment of nasolabial folds, but if the new approval is granted the market potential for the product will be significantly increased given the number people that are affected by acne scarring and the absence of any other product that has gone thru the rigors of a double-blind randomized control Clinical Study.
Conventional acne scar treatments are often labor intensive
Dr. Karnik went on to explain that treating acne scarring can be labor intensive, associated with significant down time, and require multiple visits.
“We believe ArteFill, if approved for an acne scar indication, could significantly help those who are suffering from this condition,” she said.
“Sometimes, a combination of treatments such as laser resurfacing, dermabrasion, chemical peels, and subcision will be used and results can vary. Additionally, some dermatologists use currently marketed dermal fillers, off-label, to raise the scar to the skin’s surface. The challenge is that most fillers are temporary and then the scars become depressed and visible again causing frustration and unnecessary costs to the patient.”
As noted and if approved, ArteFill will emerge to be the only dermal filler on the market approved by the FDA for treating acne scars.