Filler cleared for infraorbital hollow and horizontal forehead lines in Europe.
Merz Aesthetics has received European Union approval for two additional indications for its hyaluronic acid filler BELOTERO Balance, according to a company announcement.
The new indications are for the treatment of infraorbital hollow, including the tear trough, and horizontal forehead lines. The indications are approved in the EU only and are expected to be reflected in product labeling beginning in September 2026, the company says in a release.
According to Merz, the approvals are supported by clinical and postmarket data.
“These new indications offer additional choices backed by a well-established safety profile and consistently high patient satisfaction,” says Gonzalo Mibelli, president of the EMEA region at Merz Aesthetics, in a release.
In a clinical investigation of infraorbital hollow, 98.9% of subjects showed visible improvement at eight weeks, with results maintained for up to 72 weeks. The company reported no treatment-related serious adverse events in the study.
In a separate postmarket investigation of horizontal forehead lines, 82.7% of participants demonstrated improvement at 12 weeks, with results maintained for up to 24 weeks, according to the company. Merz also reported high patient satisfaction in the study.
“With these new approvals, BELOTERO Balance further strengthens its position as a versatile hyaluronic acid dermal filler, with a wide range of approved facial indications designed to integrate seamlessly within the skin and deliver predictable, harmonious aesthetic outcomes,” says Dr Kerstin Olsson, head of medical affairs EMEA at Merz Aesthetics, in a release.
Photo caption: BELOTERO Balance
File Photo / Merz Aesthetics
