Merz Aesthetics®, the world’s largest dedicated medical aesthetics business, is pleased to announce that BELOTERO® Balance has received EU approval for two additional indications: the treatment of infraorbital hollow (including the tear trough) and horizontal forehead lines1*.
“With these new approvals, BELOTERO® Balance further strengthens its position as a versatile hyaluronic acid dermal filler, with a wide range of approved facial indications1 designed to integrate seamlessly within the skin and deliver predictable, harmonious aesthetic outcomes,” said Dr. Kerstin Olsson, Head of Medical Affairs EMEA.
The approval of these two new indications from Merz Aesthetics is supported by compelling clinical evidence:
- In a clinical investigation on infraorbital hollow, 98.9% of subjects demonstrated visible improvement at Week 8, with long-lasting results sustained up to 72 weeks, and no treatment related serious adverse events reported.2
- Similarly, in a postmarket investigation on horizontal forehead lines, 82.7% of participants showed improvement at Week 12, accompanied by high patient satisfaction and aesthetic improvements maintained for up to 24 weeks3
- The evidence highlights the well-established safety profile, and the high level of patient satisfaction associated with BELOTERO® Balance 2-3.
“These new indications offer additional choices backed by a well-established safety profile and consistently high patient satisfaction, building on the strong momentum of BELOTERO® following its 20-year anniversary and the 2025 launch of our enhanced syringe – further demonstrating our dedication to continuous innovation and excellence in aesthetic medicine,” said Gonzalo Mibelli, President EMEA Region, Merz Aesthetics.
*Infraorbital Hollows and Horizontal Forehead Lines indications are approved in the EU only and will be reflected in the package leaflet from September 2026 onwards.
Discover the latest trends and insights—explore the Business Insights Journal for up-to-date strategies and industry breakthroughs!
