Until now, Belotero Balance (+) was indicated for injection into the mid-to-deep dermis for correction of moderate-severe facial wrinkles and folds, such as nasolabial folds and perioral lines.

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.

Overall, Belotero Balance (+) was well tolerated in the study, and the safety profile was consistent with previously reported studies, with the most common treatment-related adverse event being injection-site swelling (6.3% of subjects).

“We’re so excited to be able to offer this new Belotero Balance (+) indication to healthcare professionals and consumers and are thrilled with the promising results that we’ve seen to date through our studies,” says Patrick Urban, President, North America, Merz Aesthetics, in a news release. “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. This innovation is an impressive addition to our dermal filler portfolio here in the U.S., and one we’re very proud of.”

“This latest indication for Belotero Balance (+) is an exciting step in our U.S. brand portfolio, allowing us to provide our HCP partners with a way to help their patients correct under-eye volume loss,” adds Dr. Samantha Kerr, Chief Scientific Officer, Merz Aesthetics.

Until now, Belotero Balance (+) was indicated for injection into the mid-to-deep dermis for correction of moderate-severe facial wrinkles and folds, such as nasolabial folds and perioral lines. This FDA approval adds the indication for injection into the infraorbital hollows. 

“Infraorbital hollowing that often occurs naturally in younger people or with aging can impact a person’s confidence, which is why patients seek medical aesthetics treatment to improve the appearance of this area of the face,” says Brian S. Biesman, MD, an oculoplastic surgeon in Nashville, Tenn.“I have countless patients coming to me with concerns about under-eye volume loss,” adds Daniel Campos, the Founder and CEO at Ageless Forever Institute in Miami, Fla. “To be able to offer a safe and effective treatment from the Merz Aesthetics portfolio is an exciting advancement, and one I’m very much looking forward to bringing to my practice.”