Merz Aesthetics will submit these data as part of a supplemental Premarket Approval Application with the FDA this year.
Belotero Balance® (+) corrects volume loss in the infraorbital hollow area, according to new data from Merz Aesthetics.
Merz Aesthetics will submit these data as part of a supplemental Premarket Approval Application (sPMA) with the U.S. Food and Drug Administration (FDA) this year.
The 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.
“We are excited to share these new findings as they provide strong evidence to support our FDA filing of Belotero Balance (+) as a potential treatment for infraorbital hollowing,” says Dr. Samantha Kerr, Chief Scientific Officer, Merz Aesthetics, in a news release.
Overall, Belotero Balance (+) was well tolerated in the study, and the safety profile was consistent with previously reported studies, with the most common treatment emergent adverse event being injection-site swelling (6.3% of subjects).
“Infraorbital hollowing that often occurs naturally in younger people or with aging can impact a person’s confidence, which is why patients seek treatments to improve the appearance of this area,” adds lead investigator Dr. Brian Biesman. “This data on Belotero Balance (+) gives us an option to help patients achieve their medical aesthetics goals.”
The organization is planning to submit these data to a peer-reviewed journal at a later date.
