Merz Aesthetics, the world’s largest dedicated medical aesthetics business, announced today topline results from a pivotal study demonstrating that Belotero Balance® (+) corrects volume loss in the infraorbital hollow area. Infraorbital hollows occur in the area directly under the eye when subcutaneous fat and soft tissue volume diminishes, causing a sunken eye appearance.
The pivotal study enrolled 150 adults with moderate to severe infraorbital hollows. Subjects were randomized to a Belotero Balance (+) treatment group or a delayed treatment/control group. At Week 8 (the primary endpoint), the estimated average responder rate for the treatment group was 80.6%, while the estimated average responder rate in the control/delayed-treatment group was 1.9%. The difference between the estimated response rates was 78.7%, showing superiority of Belotero Balance (+) treatment over control. Response was defined as ≥ 1-point improvement in both infraorbital hollows compared to baseline at Week 8 on the Merz Infraorbital Hollow Assessment Scale (MIHAS) – a 5-grade, scientifically validated scale. Additionally, at Week 8, 98.9% of subjects in the treatment group showed improvement on the Global Aesthetics Improvement Scale as determined by the treating investigator.
“We are excited to share these new findings as they provide strong evidence to support our FDA filing of Belotero Balance (+) as a potential treatment for infraorbital hollowing,” said Dr. Samantha Kerr, Chief Scientific Officer, Merz Aesthetics.
Overall, Belotero Balance (+) was well tolerated in the study, and the safety profile was consistent with previously reported studies, with the most common treatment emergent adverse event being injection-site swelling (6.3% of subjects).
“Infraorbital hollowing that often occurs naturally in younger people or with aging can impact a person’s confidence, which is why patients seek treatments to improve the appearance of this area,” said lead investigator Dr. Brian Biesman. “This data on Belotero Balance (+) gives us an option to help patients achieve their medical aesthetics goals.”
Merz Aesthetics will submit these data as part of a supplemental Premarket Approval Application (sPMA) with the U.S. Food and Drug Administration (FDA) this year. The organization is planning to submit these data to a peer-reviewed journal at a later date.
About Belotero Balance (+) Lidocaine
Belotero Balance (+) is a clear hyaluronic acid injectable filler used to smooth moderate-to-severe etched-in facial lines and wrinkles in the lower face. It is known for blending evenly with natural skin tissue for a seamless feel with minimal tissue disruption. The hyaluronic acid in Belotero Balance (+) is specially formulated in a proprietary process to create a uniquely smooth and cohesive gel that blends into the natural structure of the skin, to fill etched-in lines and wrinkles while creating a smooth, natural look and feel.
Belotero Balance was first approved by the U.S. FDA in 2011 to temporarily smooth out and fill in moderate-to-severe nasolabial folds – the folds or wrinkles that go from the side of the nose to the corner of the mouth. Belotero Balance (+) Lidocaine is a newer formulation launched in 2021 with the addition of a small amount of the anesthetic medicine, lidocaine, to help reduce pain and discomfort during and after injection.
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 52 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.
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IMPORTANT SAFETY INFORMATION FOR BELOTERO BALANCE® (+):
BELOTERO BALANCE® (+) is indicated for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds.
Use of BELOTERO BALANCE® (+) in any person with active skin inflammation (skin eruptions such as cold sores, cysts, pimples, rashes, or hives) or infection in or near the treatment area should be deferred until the inflammatory or infectious process has been controlled.
In order to minimize the risks of potential complications, BELOTERO BALANCE® (+) should only be used by health care professionals who have appropriate training experience, and who are knowledgeable about the anatomy at and around the site of injection.
Health care professionals are encouraged to discuss all potential risks of soft tissue infection with their patients prior to treatment and ensure that patients are aware of the signs and symptoms of potential complications.
As with all skin injection procedures, there is a risk of infection with BELOTERO BALANCE® (+).
BELOTERO BALANCE® (+) should be used with caution in patients on immunosuppressive therapy.
The use of BELOTERO BALANCE® (+) in patients with a history of previous herpetic eruption may be associated with reactivation of the herpes.
Based on clinical trials, patients should be limited to 6.0 mL of BELOTERO BALANCE® (+) per year. The safety of injecting greater amounts has not been established.
The long-term safety and effectiveness of BELOTERO BALANCE® (+) beyond 96 weeks have not been investigated.
The safety and effectiveness of BELOTERO BALANCE® (+) during pregnancy or breastfeeding, for the treatment of dermal contour defects other than nasolabial folds, such as use in the lips, or in patients under 21 years have not been established.
The safety of BELOTERO BALANCE® (+) in patients with known susceptibility to recurrent sore throat or Osler Rendu endocarditis has not been studied.
No studies of BELOTERO BALANCE® (+) Injectable Implant with drugs or other substances or implants have been conducted.
Patients using medications that prolong bleeding, such as aspirin, non-steroidal anti-inflammatory drugs, or warfarin, may experience increased bruising and bleeding at the injection site.
Exposure of the treated area to excessive sun, UV lamp exposure, Turkish baths, and extreme cold weather should be minimized until any initial swelling and redness have resolved and puncture sites have healed.
Laser treatment, chemical peeling, or any other procedure based on active dermal response performed after treatment with BELOTERO BALANCE® (+) may increase the risk of an inflammatory reaction at the injection site.
The most common adverse events seen in clinical studies with BELOTERO BALANCE® (+) were swelling, bruising, redness, hardening of the skin, pain, altered color or itching. Other adverse events that have occurred with BELOTERO BALANCE® (+) include headache, swelling of the side of the nose, moderate cold sore, lip numbness, and lip dryness. Side effects were often mild to moderate and often resolved within 7 days.
Information on adverse events from post-market surveillance of BELOTERO BALANCE® (+) are included in the Instructions for Use (IFU) and Patient Information Guide (PIG) based on an assessment of seriousness and potential causal relationship to the products. Please see the IFU and PIG available on www.belotero.com for a complete list of these events.
To report a problem with BELOTERO BALANCE® (+), please call MyMerz Solutions at 1-844-469-6379.
For complete Safety Information, please visit www.belotero.com.