FDA Green Lights Suneva’s Acne Scar Treatment

The FDA approved Suneva’s Bellafill for the treatment of acne scarring in patients 21 and older, making it the only dermal filler currently available in the U.S. for the disfiguring skin condition, the San Diego, Calif., company said Tuesday.

Comprised largely of purified bovine collagen, Bellafill is injected into the cheeks to raise and smooth acne scars to the level of the surrounding skin. The long-lasting treatment involves little if any down time and the number of doses required depends on the level of scarring.

Approval was based on a study that compared Bellafill to a saline injection control. Patients were asked to determine whether 50 percent or more of their Bellafill treated scars improved by two or more points on an Acne Scar Rating Scale. Sixty-four percent answered in the affirmative at six months, and 71 percent at one year. Overall satisfaction with the treatment was 84 percent at six months and 90 percent at 12 months, the company said.

UCLA dermatology professor and study investigator Ava Shamban said Bellafill offers doctors the chance to “remedy acne scars and help patients live a happier, healthy life.”

The product was originally approved in 2006 under the name ArteFill to treat smile lines. Suneva changed the name in December. The company will launch Bellafill for the new indication this month.

Acne is the most common skin disorder in the U.S., affecting 40 million to 50 million people and leaving scars on up to 95 percent of those who suffer from it, according to Suneva. — Kellen Owings