Merz Aesthetics Secures Key EU Approvals for BELOTERO® Balance, Targeting High-Demand Facial Zones

FRANKFURT, Germany – March 30, 2026

Merz Aesthetics has announced it received European Union approval for two significant new indications for its hyaluronic acid (HA) filler, BELOTERO® Balance: the treatment of infraorbital hollows, commonly known as tear troughs, and horizontal forehead lines. The approval marks a pivotal expansion for the widely used dermal filler, positioning it as a more versatile tool for practitioners and a targeted solution for some of the most requested aesthetic treatments.

A Strategic Move in a Competitive Market

This regulatory milestone arrives as the European aesthetic medicine market experiences unprecedented growth. Valued at approximately USD 1.7 billion in 2025, the EU dermal filler sector is projected to expand significantly, with some analysts forecasting a market size of over USD 3 billion by 2033. Hyaluronic acid-based products dominate this space, accounting for the vast majority of non-surgical procedures performed annually.

Within this thriving but competitive landscape, Merz Aesthetics’ latest approvals for BELOTERO® Balance represent a calculated strategic maneuver. The move allows the company to more directly compete with industry giants like Galderma and Allergan/AbbVie in the lucrative segments of periorbital and upper-face rejuvenation. The wrinkle removal application segment is the largest and fastest-growing part of the HA filler market, and by securing official indications for both tear troughs and forehead lines, Merz fortifies its product's value proposition for clinicians.

"With these new approvals, BELOTERO® Balance further strengthens its position as a versatile hyaluronic acid dermal filler... designed to integrate seamlessly within the skin and deliver predictable, harmonious aesthetic outcomes,” stated Dr. Kerstin Olsson, Head of Medical Affairs EMEA for Merz Aesthetics, in the company's official announcement.

This expansion builds on the momentum of the BELOTERO® brand, which recently celebrated its 20-year anniversary and has sold over 21 million syringes worldwide. By providing officially sanctioned, evidence-backed solutions for these challenging treatment areas, Merz is poised to capture a greater share of a market driven by both an aging population and a younger demographic seeking preventative aesthetic care.

The Clinical Edge in Delicate Treatments

The EU’s green light is not merely a labeling update; it is an endorsement backed by compelling clinical data that underscores the product's suitability for these delicate facial areas. For the treatment of infraorbital hollows, a clinical study demonstrated that an impressive 98.9% of subjects showed visible improvement eight weeks post-treatment, with results lasting for up to 72 weeks. Crucially, no treatment-related serious adverse events were reported, highlighting a strong safety profile.

Aesthetic medicine experts have long favored BELOTERO® Balance for the under-eye area due to its unique rheological properties. Its cohesive polydensified matrix (CPM) technology creates a smooth, flexible gel that integrates seamlessly with surrounding tissue. Clinicians note that its lower tendency to attract water, compared to some other HA fillers, significantly reduces the risk of post-injection swelling or the Tyndall effect—a bluish discoloration that can occur when fillers are placed too superficially in thin-skinned areas. This makes it a preferred option for patients with thinner skin seeking natural-looking correction without puffiness.

Similarly, the approval for horizontal forehead lines is supported by a postmarket investigation where 82.7% of participants showed improvement at 12 weeks, with high patient satisfaction and results maintained for up to 24 weeks. This provides practitioners with a validated alternative or complement to neuromodulators like botulinum toxin, allowing them to directly fill static lines that remain etched in the skin even when the face is at rest.

Navigating a Stricter Regulatory Landscape

Securing these indications is particularly significant given the European Union's more stringent regulatory framework. The implementation of the Medical Device Regulation (MDR 2017/745) has reclassified dermal fillers as Class III medical devices, the highest risk category. This change mandates a far more rigorous approval process, requiring manufacturers to provide extensive clinical evidence to prove both safety and efficacy for each specific intended use.

The approval of BELOTERO® Balance under this demanding MDR framework lends substantial credibility to its new applications. It signals to both practitioners and patients that the product has met the highest contemporary standards for medical device safety and performance. The company has stated that the new indications will be formally included in the product's package leaflet from September 2026 onwards, marking the final step in the official regulatory rollout and authorizing Merz to market the filler for these uses across the EU.

Meeting Patient Demand for Natural Rejuvenation

Ultimately, this expansion directly addresses evolving patient desires. The modern aesthetic consumer increasingly seeks non-invasive treatments that deliver subtle, natural-looking results with minimal downtime. Tired-looking eyes and forehead wrinkles are among the most common concerns that lead individuals to seek aesthetic consultations, as these features can significantly impact one's perceived age and vitality.

By offering a clinically proven solution for tear troughs, Merz helps patients combat a perpetually fatigued appearance, boosting confidence. The option to smooth forehead lines with a filler also caters to a growing patient base that may be hesitant to use neuromodulators or requires a solution for deeply etched lines.

Gonzalo Mibelli, President of the EMEA Region for Merz Aesthetics, emphasized this patient-centric approach, noting the approvals offer "additional choices backed by a well-established safety profile and consistently high patient satisfaction." He framed the development as part of the company's "dedication to continuous innovation and excellence in aesthetic medicine," referencing the upcoming 2025 launch of an enhanced syringe for the product line. This commitment to both product efficacy and delivery systems demonstrates a holistic strategy aimed at improving the treatment experience for both the provider and the patient.

With these new, validated applications, BELOTERO® Balance is better equipped to meet the nuanced demands of the modern aesthetic market, offering precise and reliable outcomes for some of the face's most expressive and challenging areas.