Merz Aesthetics announced today that the U.S. Food and Drug Administration (FDA) has approved Belotero Balance (+) for volume augmentation for the improvement of the infraorbital hollow (IOH) in adults over the age of 21, further expanding the usage and capability of Belotero Balance (+), and addressing consumer under-eye concerns. “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,” said Patrick Urban, president, North America, Merz Aesthetics. “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 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 percent, while the estimated average responder rate in the control/delayed-treatment group was 1.9 percent. The difference between the estimated response rates was 78.7 percent, 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 percent of subjects in the treatment group showed improvement on the Global Aesthetics Improvement Scale as determined by the treating investigator. “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,” said Dr. Samantha Kerr, chief scientific officer, Merz Aesthetics.
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 percent of subjects).
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 refers to the U-shaped depression under the eyes that extends from the nasal bone to the outer corner of the eye. Infraorbital hollows occur in the area directly under the eye when subcutaneous fat and soft tissue volume diminishes.
Unique technology makes Belotero Balance different from other hyaluronic acid (HA) fillers. It is manufactured using the advanced Dynamic Cross-Linking Technology (DCLT), leading to tailored Cohesive Polydensified Matrix (CPM) consisting of a monophasic gel, providing the ideal rheology for seamless, natural tissue integration in the under-eye hollows.
First approved in 2011, Belotero Balance is a hyaluronic acid (HA) filler that provides a smooth, all-around refinement for filler patients. Belotero Balance (+) offers the same benefits plus the advantages of a lidocaine formulation.
Belotero Balance (+) is an injectable filler known for blending evenly with skin tissue for a seamless feel with minimal tissue disruption. The HA in Belotero Balance (+) is specially formulated in a proprietary process to create a uniquely smooth and cohesive gel that blends into the structure of the skin, while creating a smooth, natural look and feel.