Suneva Medical announced that the Food and Drug Administration (FDA) has approved Bellafill for the correction of moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over age 21.

Bellafill is made up of 80% purified bovine collagen gel, and is the first dermal filler approved for use in this condition. Bellafill injection contains 0.3% lidocaine for added comfort and has low immunogenicity. The injected collagen works by it being resorbed over time as new enndogenous collagen is formed between the microspheres.

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The approval of Bellafill was based on data from a double-blinded, randomized, placebo-controlled study in which patients were treated at 10 clinical centers. The primary efficacy endpoint was superiority with Bellafill vs. Control saline injection at six months. A responder was defined as a patient who had ≥50% of treated acne scars improve by two or more points on a validated 4-point Acne Scar Rating Scale (ASRS). Results showed that the response rate for treatment with Bellafill was 64% vs. 33% for Control at six months (P=0.0005). At 12 months, Bellafill showed lasting efficacy of 71% by an unblinded assessment.

Treatment with Bellafill can be performed as an in-office procedure with minimal to no downtime for the patient. Bellafill is already approved for the correction of facial wrinkles, also known as nasolabial folds.

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