Merz Aesthetics announced that in the EU, the BELOTERO Balance filler has been approved for two new indications: correction of the infraorbital hollow, including the tear trough, and correction of horizontal forehead lines. For the brand, this marks a significant regulatory update, as it is not about a general expansion of positioning but an official approval for use in two specific areas that are often requested in aesthetic medicine practice.
The company emphasizes that the new approvals further strengthen BELOTERO Balance's position as a versatile hyaluronic dermal filler with a wide range of indications for facial application. Merz Aesthetics also highlights the product's ability to integrate into skin tissues and deliver predictable, harmonious aesthetic results.
"With these new approvals, BELOTERO Balance further solidifies its position as a versatile hyaluronic dermal filler with a broad spectrum of approved facial indications, designed for seamless integration into the skin and achieving predictable, harmonious aesthetic results."
Dr. Kerstin Olsson, Head of Medical Affairs EMEA at Merz Aesthetics.
What exactly has been approved for BELOTERO Balance in the EU?
There are two separate indications. The first is the correction of the infraorbital hollow, including the tear trough. The second is the correction of horizontal forehead lines. Both areas are explicitly mentioned in the company's official publication as new approved indications for the European Union.
For the aesthetic medicine market, this news is important not only as a formal regulatory update. It signifies that the manufacturer has received confirmation for the product's use specifically in these areas, based on separate clinical data regarding efficacy, safety, and patient satisfaction.
What new indications has BELOTERO Balance received?
Correction of the infraorbital hollow
One of the new indications is the correction of the infraorbital hollow, including the tear trough. This is an area where practitioners work with particular caution, as it involves a delicate anatomical region with high demands for precision, predictability, and natural results. Therefore, the appearance of a separate approval for this area is significant for practice.
Merz Aesthetics notes that for this indication, BELOTERO Balance demonstrated convincing clinical results. The company emphasizes not only visible improvement but also the duration of the effect and the absence of treatment-related serious adverse events within the study it references.
Correction of horizontal forehead lines
The second new indication is the correction of horizontal forehead lines. For this area, the naturalness of the result, smooth integration of the product into tissues, and patient satisfaction are also of particular importance, as any correction in the forehead area is very noticeable in facial expressions.
The release highlights that the new approval for this area complements the product's existing indications and expands its official application possibilities in European practice.
On what clinical data is this decision based?
Merz Aesthetics explicitly states that both new indications are supported by clinical data. For the infraorbital hollow, the company references a clinical study in which 98.9% of participants showed visible improvement by the 8th week. The publication also notes that results were maintained up to 72 weeks, and treatment-related serious adverse events were not reported.
For horizontal forehead lines, the company provides data from a postmarket investigation. According to its information, 82.7% of participants showed improvement by the 12th week, with a high level of patient satisfaction reported, and aesthetic improvements maintained up to 24 weeks.
Collectively, these data, according to Merz Aesthetics, underscore the well-established safety profile of BELOTERO Balance and consistently high patient satisfaction. This is one of the key focuses of the release.
"These new indications provide additional choice options, confirmed by a well-established safety profile and consistently high patient satisfaction. They continue the strong development momentum of BELOTERO after the brand's 20th anniversary and the launch of our enhanced syringe in 2025, once again demonstrating our commitment to continuous innovation and excellence in aesthetic medicine."
Gonzalo Mibelli, President of the EMEA region at Merz Aesthetics.
What does this mean for aesthetic medicine practice?
For practitioners, this news means an expansion of official indications for work with two in-demand aesthetic areas - under the eyes and in the forehead area. For patients, it means that the company has received regulatory confirmation specifically for these correction directions, based on a clinical foundation, not just general product positioning.
The publication also clarifies that the indications for the infraorbital hollow and horizontal forehead lines are approved specifically in the EU and will be reflected in the package leaflet starting from September 2026. This is an important detail as it outlines the regulatory framework for application and the geography of this update.
About BELOTERO Balance
BELOTERO Balance is an injectable hyaluronic acid-based product designed to fill facial wrinkles and folds and restore volume. The release notes that the product is indicated for injection into the superficial and mid-dermis for the correction of nasolabial folds, marionette lines, perioral lines, horizontal forehead lines, and oral commissures.
The product is also indicated for injection into the supraperiosteal plane for the correction of the infraorbital hollow, including the tear trough. Indications for submucosal or subcutaneous injection for lip augmentation are also separately noted. Thus, the new EU approvals logically fit into the already broader set of facial indications for this filler.
About the BELOTERO Collection
Merz Aesthetics reminds that BELOTERO is a collection of hyaluronic fillers based on 20 years of scientific research, clinical experience, and practical application. According to the company, over 21 million syringes have been sold worldwide, the brand is represented in more than 90 countries, and its scientific base is supported by over 150 scientific publications.
The release also emphasizes that the BELOTERO portfolio is created as a comprehensive line of highly cohesive hyaluronic fillers designed to provide predictable and harmonious results through seamless integration into tissues. The full portfolio, according to the company, offers solutions for enhancing facial features, improving skin quality, and reducing visible signs of aging with long-lasting and natural visual effects.
Brief Information about Merz Aesthetics
Merz Aesthetics is a company in the field of medical aesthetics with a long history, working with medical professionals, patients, and its own teams to help them feel more confident every day. The company's portfolio includes injectable products, device solutions, and skincare products created with patient needs and high standards of safety and efficacy in mind.
The company has remained a family business for over 115 years. Merz Aesthetics' global headquarters is located in Raleigh, North Carolina, USA, and its commercial presence spans 90 countries worldwide. Merz Aesthetics is also part of the Merz Group, founded in 1908 in Frankfurt, Germany.
More details in the official Merz Aesthetics publication on Business Wire
