Merz Aesthetics’ Belotero Balance (+) Receives FDA Approval for Infraorbital Hollows

The U.S. Food and Drug Administration (FDA) approved Merz Aesthetics’ Belotero Balance (+) for improvement of the infraorbital hollow (IOH) in adults over the age of 21.

This approval stems from positive pivotal study results demonstrating the efficacy and safety of Belotero Balance (+) for the treatment of infraorbital hollows in June of 2023. This pivotal study enrolled 150 adults with moderate to severe infraorbital hollows. Subjects were randomized to a Belotero Balance (+) treatment group or a delayed treatment/control group. At Week 8 (the primary endpoint), the estimated average responder rate for the treatment group was 80.6%, while the estimated average responder rate in the control/delayed-treatment group was 1.9%. The difference between the estimated response rates was 78.7%, showing superiority of Belotero Balance (+) treatment over control. Response was defined as ≥ 1-point improvement in both infraorbital hollows compared to baseline at Week 8 on the Merz Infraorbital Hollow Assessment Scale (MIHAS) – a 5-grade, scientifically validated scale. Additionally, at Week 8, 98.9% of subjects in the treatment group showed improvement on the Global Aesthetics Improvement Scale as determined by the treating investigator.

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