FDA approves Suneva's Bellafill dermal filler for treatment of acne scars

Suneva Medical announced that the FDA has approved its dermal filler, Bellafill, for treating acne scars.

Bellafill is designed to add volume to the skin to smooth out pitted acne scars through an in-office injection procedure with little-to-no downtime, according to a company press release.

The FDA action was based on results of a double-blind, randomized study at 10 U.S. clinical centers in which Bellafill was found to be an effective, well-tolerated treatment for acne scars compared with the use of a control saline injection at 6 months.

Patients with 50% or more of treated acne scars that improved by two or more points on a validated four-point Acne Scar Rating Scale (ASRS) were classified as responders. The response rate for Bellafill at was 64% compared with 33% for control patients (P= .0005).

The treatment continued to show effectiveness among 71% of patients in an unblinded assessment at 12 months, according to the release.

Additionally, 84% of patients reported satisfaction at 6 months following treatment (blinded), and 90% reported satisfaction at 1 year (unblinded).

Ava Shamban

“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,” investigator Ava Shamban, MD, said in the release. “I look forward to using this proven treatment option with patients.”

Reference: www.sunevamedical.com.