Belotero Balance hyaluronic acid (HA) dermal filler from pharmaceutical company Merz Aesthetics has received US Food and Drug Administration (FDA) approval for under-eye treatments.
The product has now been approved for use in the infraorbital hollows in adults over the age of 21, with the company saying this development means the filler can be used to address under-eye concerns.
A study conducted in June 2023 saw 150 patients with moderate to severe infraorbital hollows separated into a control group and a Belotero Balance group. At week eight, the estimated average responder rate for the Belotero Balance group was 80.6%, while the estimated average responder rate in the control group was 1.9%. The difference between the estimated response rates was 78.7%, with Merz Aesthetics saying this shows superiority of Belotero Balance treatment over control.
Patrick Urban, president of Merz Aesthetics in North America, said “We’re so excited to be able to offer this new Belotero Balance indication to healthcare professionals, and consumers are thrilled with the promising results that we’ve seen to date through our studies. At Merz Aesthetics, we hold ourselves to the standard of always continuing to innovate and offer the best possible treatments for our customers to bring to their patients.”