Merz Aesthetics® Brings Comprehensive BELOTERO® Hyaluronic Acid Portfolio to U.S. Market with FDA Approvals of BELOTERO VOLUME® (+) and BELOTERO INTENSE® (+)

New additions broaden the BELOTERO^® U.S. portfolio, providing healthcare professionals with a comprehensive range of hyaluronic acid (HA) treatments designed to support individualized treatment plans across facial balancing, volume restoration, and lip enhancement.

• Merz Aesthetics expands the BELOTERO^® collection in the U.S. with the addition of BELOTERO VOLUME^® (+) and BELOTERO INTENSE^® (+), joining BELOTERO BALANCE^® (+) to offer healthcare professionals a broader portfolio of hyaluronic acid treatments.
• Built on Merz Aesthetics' proprietary Cohesive Polydensified Matrix (CPM^®) gel, every BELOTERO^® treatment is biomimetic by design, helping support seamless tissue integration for natural-looking results that preserve individual expression.^1-4
• Anticipated commercial availability is October 14, 2026 for BELOTERO VOLUME^® (+) and December 1, 2026 for BELOTERO INTENSE^® (+).

RALEIGH, N.C.--(BUSINESS WIRE)--Merz Aesthetics, the world's largest dedicated medical aesthetics business, today announced the expansion of its premium BELOTERO^® hyaluronic acid (HA) portfolio in the United States with FDA approval of BELOTERO VOLUME^® (+) to improve volume deficit in the mid-face or to correct midface contour deficiencies in adults 22 years or older, and BELOTERO INTENSE^® (+) to temporarily add volume and improve lip fullness in adults over the age of 21.^5,6

Backed by more than two decades of international clinical experience, the portfolio now spans three complementary biomimetic HA treatments, BELOTERO BALANCE^® (+), BELOTERO VOLUME^® (+) and BELOTERO INTENSE^® (+), designed to address a wider spectrum of provider and patient needs across facial balancing, volume restoration, contouring, and lip enhancement – all rooted in a unified philosophy of seamless tissue integration and natural-looking results.

A New Era of BELOTERO^® in the U.S. Supports a Market Need for Natural-Looking Results

As the world's largest market for hyaluronic acid treatments, the U.S. continues to see strong demand for personalized, natural-looking aesthetic outcomes. With lips and cheeks consistently ranking among the most requested treatment areas and 74% of patients reporting they prefer treatments that enhance, rather than transform, their appearance, BELOTERO VOLUME^® (+) and BELOTERO INTENSE^® (+), expand the portfolio to meet evolving patient demand with tailored aesthetic solutions.^7,8 Powered by Merz Aesthetics’ patented Cohesive Polydensified Matrix (CPM^®) gel, BELOTERO^®'s biomimetic design allows the gel to mimic skin tissue at every depth, delivering the natural-looking outcomes patients are seeking.^2,9

"The FDA approvals of BELOTERO VOLUME^® (+) and BELOTERO INTENSE^® (+) represent an important milestone for Merz Aesthetics in the U.S.,” said Patrick Urban, President of Merz Aesthetics North America. "By expanding the BELOTERO^® portfolio and complementing our broader injectable offerings, we're strengthening our ability to support healthcare professionals with a more comprehensive range of solutions, helping them meet diverse patient needs through a single trusted partner."

Improving Outcomes Through Biomimetic Principles

The scientific rigor behind BELOTERO^® demonstrates how biomimetic science solves a long-standing tension in hyaluronic acid filler design: delivering visible results without compromising natural movement. The BELOTERO^® portfolio achieves this through three core principles: seamless integration into the skin, dynamic adaptability to facial expression, and structural support for lasting results, an approach that fundamentally changes how providers approach facial enhancement.²

• BELOTERO VOLUME^® (+) is designed to restore volume and contour in the cheeks and midface, helping address age-related volume loss with natural-looking results that preserve facial expression.^2,3,5,9 Through its CPM^® gel, BELOTERO VOLUME^® (+), creates smooth transitions between treated and untreated areas while delivering demonstrated results lasting up to 18 months.⁴
• BELOTERO INTENSE^® (+) is designed for lip augmentation, temporarily adding volume and improving lip fullness while supporting natural movement in one of the face's most dynamic treatment areas.⁶ Engineered to integrate seamlessly into lip tissue, BELOTERO INTENSE^® (+) helps patients achieve enhanced yet authentic-looking results.^2,3,9

"BELOTERO VOLUME^® (+) and BELOTERO INTENSE^® (+) are the culmination of years of research into how hyaluronic acid naturally behaves in skin," said Dr. Samantha Kerr, Chief Scientific Officer at Merz Aesthetics. "Developed with biomimetic design principles, these treatments are engineered to work in harmony with tissue and support natural-looking outcomes across diverse patient needs. With these two products now available alongside BELOTERO BALANCE^® (+), providers have a unified portfolio they can confidently use across the full spectrum of aesthetic goals."

Clinical Perspective: A Portfolio That Aligns Science and Clinical Reality

Every product in the BELOTERO^® portfolio is created with clinically-validated science to deliver on the same core promise: seamless tissue integration and natural-looking results.

• BELOTERO VOLUME^® (+) features a proprietary dual cross-linking technology that allows for intentional customization that mirrors the natural variations in skin tissue across patients, delivering the consistency and control providers need to achieve the results their patients want. In clinical studies, 95% of patients receiving BELOTERO VOLUME^® (+) were satisfied with their results at 12 weeks.^2,5
• BELOTERO INTENSE^® (+) was developed specifically for patients seeking subtle, natural-looking lip enhancement without sacrificing movement or expression. Clinical data showed 100% patient satisfaction*, with volume maintained for up to 12 months following treatment, demonstrating durable results in one of the face's most expressive treatment areas.^6,10
• BELOTERO BALANCE^® (+), which received FDA clearance in 2021, is best for smoothing moderate to severe facial wrinkles and folds, making it ideal for areas such as perioral lines, infraorbital hollows, nasolabial folds, oral commissures and marionette lines.¹¹ Clinical studies show results that last up to 18 months, with 98% patient satisfaction^†.^11,12

"One of the greatest advantages of a broad hyaluronic acid portfolio is the ability to treat each patient with the right product for the right indication," said Dr. Michelle Henry, board-certified dermatologist. "Whether treating the midface, lips or facial lines, the expanded BELOTERO^® portfolio allows providers to work with products designed around the same principles of tissue integration and natural movement. That consistency can help support treatment planning while delivering results that look and feel authentic to patients."

For complete prescribing information, indications, and safety data, visit www.BELOTERO.com.

Keep up with BELOTERO^® on Instagram @beloterousa.

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., 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 us.merzaesthetics.com.

*As measured by the participant-reported Global Aesthetic Improvement Scale at 8 weeks post-last clinical trial treatment.

^†As measured by the participant-reported Global Aesthetic Improvement Scale at week 8 of the pivotal study for approval.

References

1. Patent Note: WO 2005/085329 “Biocompatible crosslinked gel.”
2. Casabona G., Davidovic, K., & Borrelli, M. R. 2026. Dermatologic surgery. Tissue-Plane Adaptability in Hyaluronic Acid Gels of Five Crosslinking Technologies: A Comparative Ex Vivo Ultrasound Analysis.
3. Fagien S, et al. 2019. Plast Reconstr Surg. Rheologic and Physicochemical Properties Used to Differentiate Injectable Hyaluronic Acid Filler Products.
4. Micheels P et al. 2015. J Clin Aesthet Dermatol. Treatment of Age-related Mid-face Atrophy by Injection of Cohesive Polydensified Matrix Hyaluronic Acid Volumizer.
5. Belotero Volume (+) [Prescribing Information and Instructions for Use]. IN00241-00. Merz North America, Inc; 2026.
6. Belotero Intense (+) [Prescribing Information and Instructions for Use]. IN00262-00. Merz North America, Inc; 2026.
7. Merz Aesthetics Data on File.
8. Nielsen Consumer A+U Study Data 2025
9. Prasetyo AD, et al. 2016. Clin Cosmet Investig Dermatol. Hyaluronic acid fillers with cohesive polydensified matrix for soft-tissue augmentation and rejuvenation: a literature review.
10. Gerber PA, da Mota R, Gauglitz G, Greiner-Krüger D, Sebastian M, Prager W, Kravtsov M, Carreon C, Tseng Y, Sattler S. Effectiveness and Safety of Belotero Intense ± Lidocaine for the Correction of Nasolabial Folds, Marionette Lines, and Lip Volume Enhancement: A Randomized Post-Market Clinical Follow-Up Study. Aesthet Surg J Open Forum. 2026 Mar 11;8:ojag031.
11. Belotero Balance (+) [Instructions for Use]. IN00201-01. Merz North America, Inc; 2023.
12. Biesman BS, Montes JR, Radusky RC, Mersmann S, Graul VW. A Prospective, Multicenter, Evaluator-Blind, Randomized, Controlled Study of Belotero Balance (+), a Hyaluronic Acid Filler With Lidocaine, for Correction of Infraorbital Hollowing in Adults. Aesthet Surg J. 2024 Aug 20;44(9):976-986.

What are BELOTERO BALANCE^® (+), BELOTERO VOLUME^® (+), and BELOTERO INTENSE^® (+)?

BELOTERO BALANCE^® (+) is a hyaluronic acid dermal filler used for smoothing moderate to severe facial wrinkles and folds, such as nasolabial folds (the creases that extend from the corner of your nose to the corner of your mouth) and also used to add volume beneath the eyes to improve the hollow, sunken appearance of the infraorbital area in adults over the age of 21.

BELOTERO VOLUME^® (+) is a hyaluronic acid dermal filler used to restore volume in the midface and correct midface contour deficiencies, including adding fullness to the cheeks, in adults 22 years of age or older.

BELOTERO INTENSE^® (+) is a hyaluronic acid dermal filler injected directly into and around the lips to temporarily add volume and improve lip fullness in adults over the age of 21.

BELOTERO BALANCE^® (+), BELOTERO VOLUME^® (+), AND BELOTERO INTENSE^® (+) IMPORTANT SAFETY INFORMATION

Who should not use these products?

You should not use BELOTERO BALANCE^® (+), BELOTERO VOLUME^® (+), or BELOTERO INTENSE^® (+) if you have severe allergies with a history of anaphylaxis or multiple severe allergies, or an allergic reaction to any product component, including small amounts of protein from bacteria. You should not use BELOTERO BALANCE^® (+), BELOTERO VOLUME^® (+), or BELOTERO INTENSE^® (+) if you are allergic to lidocaine or similar anesthetics. If you easily develop large scars or keloids, you should not use these products — with BELOTERO INTENSE^® (+), scarring may occur where the product is injected.

What is the most important information I should know about these products?

One of the risks with using these products is unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms, or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should notify your health care practitioner immediately.

Because of this risk, your doctor may check your vision before and after treatment with any of these products and should know in advance which eye specialist to contact if you were to experience an eye-related complication.

Do not use these products if you have a skin infection, cold sore, pimple, cyst, or rash at the treatment site until it has healed.

It is not known if these products are safe or effective if you are pregnant or breastfeeding, or if you are under 21 years old (for treatment of the infraorbital hollow with BELOTERO BALANCE^® (+), or for lip augmentation with BELOTERO INTENSE^® (+) or under 22 years old (for midface treatment with BELOTERO VOLUME^® (+).

It is also not known if BELOTERO BALANCE^® (+) is safe or effective beyond 96 weeks.

If you have a history of cold sores, you may experience a breakout after treatment.

What should I tell my doctor before treatment?

Tell your health care provider if you are taking blood thinners or medicines that can interfere with clotting, such as aspirin or warfarin, as these may increase your risk of bruising or bleeding at the injection site. Tell your doctor if you are taking medicines that decrease your body’s natural defenses (immunosuppressants), as this may increase your risk of infection. Tell your doctor about any past skin treatments, such as laser treatment or chemical peels.

What are the most common side effects?

The most common side effects seen in clinical studies include swelling, bruising, redness, pain or tenderness, firmness, itching, and lumps or bumps at the injection site; soreness was also commonly reported with BELOTERO INTENSE^® (+) lip treatment. Most of these side effects are temporary and resolve within 1 to 4 weeks, though in some people they may last longer. In studies of the infraorbital hollow and of the lips, bruising and visible lumps were reported somewhat more often than in studies of the nasolabial folds or midface.

Delayed-onset inflammation near the site of injection is a known side effect of dermal fillers. Cases have been reported to occur following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, this inflammation responds to treatment or resolves on its own.

These are not all of the possible side effects with these products. Merz collects information about side effects seen with these products outside of clinical studies. These events are included in the Patient Information Guide based on an assessment of seriousness and potential causal relationship to the product. Please see the Patient Information Guide available at www.belotero.com for a list of these events. Tell your health care provider about any side effect that bothers you or does not go away.

Important: For full safety information, please visit www.belotero.com or call MyMerz Solutions at 1-844-469-6379.

BELOTERO BALANCE^® (+), BELOTERO VOLUME^® (+), and BELOTERO INTENSE^® (+) are available by prescription only.

© 2026 Merz North America, Inc. All rights reserved. MERZ AESTHETICS, BELOTERO, and BELOTERO BALANCE are registered trademarks of Merz Pharma GmbH & Co. KGaA in the U.S.