Merz Aesthetics ® Announces EU Approval of Two New Indications for Their Hyaluronic Acid Filler BELOTERO ® Balance

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 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.

About BELOTERO^® Balance:

BELOTERO Balance is a hyaluronic acid injectable intended for the filling of facial wrinkles and folds as well as for volume enhancement. It is indicated for injection into the superficial to mid dermis for the treatment of nasolabial folds, marionette lines, perioral lines, horizontal forehead lines, and oral commissures, and into the supraperiosteal plane for the enhancement of the infraorbital hollow, including tear troughs. It is also indicated for submucosal or subcutaneous injection for lip enhancement.¹

About the BELOTERO^® Collection:

Building on 20 years of scientific research, clinical success, and real-world experience, BELOTERO^® is one of the most trusted Hyaluronic Acid Fillers collection worldwide, with more than 21 million syringes sold and a presence in over 90 countries and over 150 scientific publication ⁴. BELOTERO^® is a thoughtfully designed, comprehensive range of highly cohesive hyaluronic acid fillers, developed to deliver predictable, harmonious results through seamless tissue integration. The full portfolio offers tailored solutions to enhance facial features, improve skin quality, and visibly reduce signs of aging, all with long-lasting**, natural-looking outcomes^5-6.

About Merz Aesthetics^®

Merz Aesthetics is a medical aesthetics business with a long history of empowering health care professionals, patients and employees to live every day with confidence. We aim to help people around the world look, feel and live like the best versions of themselves — however they define it. Clinically proven, its product portfolio includes injectables, devices and skin care treatments designed to meet each patient’s needs with high standards of safety and efficacy. Being family owned for more than 115 years, Merz Aesthetics is known for building unique connections with customers who feel like family. Merz Aesthetics’ global headquarters is in Raleigh, N.C., USA, with a commercial presence in 90 countries worldwide. It is also a part of Merz Group, which was founded in 1908 and is based in Frankfurt, Germany. Learn more at merzaesthetics.com.

References

1. BELOTERO® Balance Lidocaine Instructions for Use. 2026. Merz Aesthetics.
2. Clinical Study Report. Evaluation of Effectiveness and Safety of Belotero® Balance Lidocaine for Volume Augmentation of the Infraorbital Hollow. 2022.
3. Clinical Investigation Report. Post-Market Clinical Follow-Up Study of Belotero® Balance Lidocaine in Horizontal Forehead Lines. 2024.
4. Merz Aesthetics, Data on File, 2026.
5. Molliard S.G., et al. J Med Behav Biomed Mater. 2016;61:290-8.
6. Van Loghem, J. et al. Clin Cosm Inv Dermatol. 2021:14 1175-1

** Depending on product used, effects duration ranges from 6 months to 18 months based on clinical data.

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