The FDA has approved Suneva Medical's dermal filler, Bellafill, for the treatment of moderate to severe, atrophic, distensible facial acne scars in patients aged >21 years.
The FDA has approved Suneva Medical’s dermal filler, Bellafill, for the treatment of moderate to severe, atrophic, distensible facial acne scars in patients aged >21 years. With this FDA nod, Bellafill is now the only filler on the market approved for treating acne scars.
Bellafill treats acne scars by adding volume to the skin, which lifts and smooths pitted acne scars to the level of the surrounding skin. The long-lasting treatment can be administered in a simple, in-office procedure with minimal to no downtime, according to a press release from Suneva Medical.
“In the dermatology field, we regularly see patients who live with the burden of acne scarring—a physical and emotional burden that leads many to feel depressed, less energetic and less social. With Bellafill, we have a tremendous opportunity to remedy acne scars and help patients live a happier, healthy life,” said Dr. Ava Shamban, assistant clinical professor of Dermatology at UCLA and an investigator in the Bellafill acne scar study, in a press release. “The level of acne scar correction Bellafill achieves is truly impressive and I greatly look forward to using this proven treatment option with patients.”
The FDA based its approval of Bellafill on the results of a double-blinded, randomized, placebo-controlled pivotal study in which patients with acne scars were treated at 10 US clinical centers. After a 6-month period, 64% of patients who were treated with Bellafill had >50% of their treated acne scars improve by 2 or more points on a validated 4-point Acne Scar Rating Scale, compared with 33% of patients who were treated with a control saline injection.
“These types of acne scars affect millions of people and can have a profoundly negative impact on their self-esteem and self-confidence,” said Suneva Medical Chairman and CEO Nicholas L. Teti, Jr, in the press release. “The results of this rigorous clinical study prove that Bellafill reduces the appearance of acne scars—providing a solution to this widespread skin condition that previously had limited treatment choices. Bellafill can have a transformational effect on a patient's appearance and in turn, we hope an improvement in quality of life.”