RALEIGH, N.C.--(BUSINESS WIRE)--Merz Aesthetics, the world’s largest dedicated medical aesthetics business, announced today the U.S. Food and Drug Administration (FDA) approved Belotero Balance® (+) for volume augmentation for the improvement of the infraorbital hollow (IOH) in adults over the age of 21, further expanding the usage and capability of Belotero Balance® (+), and addressing consumer under-eye concerns..

美国食品和药物管理局（FDA）今天宣布，美国食品和药物管理局（FDA）批准BeloteroBalance®（+）用于体积增大，以改善21岁以上成年人的眶下中空（IOH），进一步扩大BeloteroBalance®（+）的使用和能力，并解决消费者关注的问题。。

“We’re so excited to be able to offer this new Belotero Balance® (+) indication to healthcare professionals and consumers and are thrilled with the promising results that we’ve seen to date through our studies,” said Patrick Urban, President, North America, Merz Aesthetics. “At Merz Aesthetics, we hold ourselves to the standard of always continuing to innovate and offer the best possible treatments for our customers to bring to their patients.

总统帕特里克·城市（Patrick Urban）说：“能够向医疗保健专业人员和消费者提供这种新的BeloteroBalance®（+）指示，我们非常兴奋，并且对我们迄今为止通过研究看到的有希望的结果感到兴奋，北美美尔兹美学。“在Merz Aesthetics，我们坚持始终不断创新的标准，并为我们的客户为患者提供最好的治疗方法。

This innovation is an impressive addition to our dermal filler portfolio here in the U.S., and one we’re very proud of.”.

这项创新是我们在美国的真皮填充剂组合的一个令人印象深刻的补充，我们非常自豪。”。

This approval stems from positive pivotal study results demonstrating the efficacy and safety of Belotero Balance® (+) for the treatment of infraorbital hollows in June of 2023. This 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.

该批准源于积极的关键性研究结果，证明了BeloteroBalance®（+）在2023年6月治疗眶下空洞的有效性和安全性。这项关键性研究招募了150名患有中度至重度眶下凹陷的成年人。受试者被随机分配到Belotero Balance（+）治疗组或延迟治疗/对照组。

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.

在第8周（主要终点），治疗组的估计平均应答率为80.6%，而对照/延迟治疗组的估计平均应答率为1.9%。估计应答率之间的差异为78.7%，显示低于平衡（+）治疗优于对照。

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..

反应定义为在Merz眶下中空评估量表（MIHAS）上，与第8周的基线相比，眶下空洞均改善≥1分-这是一种经过5级科学验证的量表。此外，在第8周，治疗组中98.9%的受试者在治疗研究者确定的全球美学改善量表上显示出改善。。

“This latest indication for Belotero Balance® (+) is an exciting step in our U.S. brand portfolio, allowing us to provide our HCP partners with a way to help their patients correct under-eye volume loss,” said Dr. Samantha Kerr, Chief Scientific Officer, Merz Aesthetics.

“BeloteroBalance®（+）的最新迹象是我们美国品牌产品组合中的一个令人兴奋的步骤，使我们能够为我们的HCP合作伙伴提供一种帮助他们的患者纠正眼内容量减少的方法，”Merz Aesthetics首席科学官Samantha Kerr博士说。

Overall, Belotero Balance (+) was well tolerated in the study, and the safety profile was consistent with previously reported studies, with the most common treatment-related adverse event being injection-site swelling (6.3% of subjects).

总体而言，研究中Belotero Balance（+）的耐受性良好，安全性与先前报道的研究一致，最常见的治疗相关不良事件是注射部位肿胀（6.3%的受试者）。

Until now, Belotero Balance® (+) was indicated for injection into the mid-to-deep dermis for correction of moderate-severe facial wrinkles and folds, such as nasolabial folds and perioral lines. This FDA approval adds the indication for injection into the infraorbital hollows. Infraorbital hollowing refers to the U-shaped depression under the eyes that extends from the nasal bone to the outer corner of the eye.

到目前为止，BeloteroBalance®（+）适用于注射到中深层真皮中，以矫正中重度面部皱纹和褶皱，如鼻唇沟和口周线。FDA的批准增加了注射到眶下空洞的指征。眶下空洞是指眼睛下方从鼻骨延伸到眼睛外角的U形凹陷。

Infraorbital hollows occur in the area directly under the eye when subcutaneous fat and soft tissue volume diminishes..

当皮下脂肪和软组织体积减少时，眶下凹陷发生在眼睛正下方的区域。。

Unique technology makes Belotero Balance® different from other hyaluronic acid (HA) fillers. It is manufactured using the advanced Dynamic Cross-Linking Technology (DCLT), leading to tailored Cohesive Polydensified Matrix (CPM®) consisting of a monophasic gel, providing the ideal rheology for seamless, natural tissue integration in the under-eye hollows..

独特的技术使BeloteroBalance®与其他透明质酸（HA）填料不同。它采用先进的动态交联技术（DCLT）制造，可定制由单相凝胶组成的粘性聚致密基质（CPM®），为眼下空洞中无缝，天然组织整合提供理想的流变学。。

“Infraorbital hollowing that often occurs naturally in younger people or with aging can impact a person’s confidence, which is why patients seek medical aesthetics treatment to improve the appearance of this area of the face,” said Brian S. Biesman, M.D. F.A.C.S.

Brian s.Biesman，M.D.F.a.C.s.说：“通常在年轻人或随着年龄增长而自然发生的眶下空洞会影响一个人的信心，这就是为什么患者寻求医疗美学治疗以改善面部这一区域外观的原因。”。

“I have countless patients coming to me with concerns about under-eye volume loss,” adds Dr. Daniel Campos, DNP, APRN Board-Certified specializing in non-surgical aesthetic and anti-aging treatments in Miami, Florida. “To be able to offer a safe and effective treatment from the Merz Aesthetics portfolio is an exciting advancement, and one I’m very much looking forward to bringing to my practice.”.

佛罗里达州迈阿密市专门从事非手术美容和抗衰老治疗的APRN认证Daniel Campos博士补充说：“我有无数患者担心眼睛容量不足。”。“能够从Merz美学组合中提供安全有效的治疗方法是一项激动人心的进步，我非常期待将其应用于实践中。”。

First approved in 2011, Belotero Balance® is a hyaluronic acid (HA) filler that provides a smooth, all-around refinement for filler patients. Belotero Balance® (+) offers the same benefits plus the advantages of a lidocaine formulation.

BeloteroBalance®于2011年首次获得批准，是一种透明质酸（HA）填充剂，可为填充剂患者提供平稳，全面的精制。BeloteroBalance®（+）提供相同的优势以及利多卡因配方的优势。

Belotero Balance® (+) is an injectable filler known for blending evenly with skin tissue for a seamless feel with minimal tissue disruption. The HA in Belotero Balance® (+) is specially formulated in a proprietary process to create a uniquely smooth and cohesive gel that blends into the structure of the skin, while creating a smooth, natural look and feel..

BeloteroBalance®（+）是一种可注射填充剂，以与皮肤组织均匀混合，获得无缝感，组织破坏最小。BeloteroBalance®（+）中的HA专门采用专有工艺配制，可形成独特光滑，粘合的凝胶，融合到皮肤结构中，同时创造出光滑，自然的外观和感觉。。

About Merz Aesthetics

关于梅尔兹美学

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.

梅尔兹美学是一项医学美学业务，拥有悠久的历史，使医疗保健专业人员，患者和员工能够每天充满信心地生活。我们的目标是帮助世界各地的人们看起来，感觉和生活像他们自己的最佳版本-无论他们如何定义它。经过临床验证，其产品组合包括注射剂，设备和护肤品，旨在满足每位患者的高标准安全性需求和功效。

Being family owned for more than 110 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.

作为家族拥有110多年，Merz Aesthetics以与感觉像家人的客户建立独特的联系而闻名。Merz Aesthetics的全球总部位于美国北卡罗来纳州罗利，在全球52个国家设有商业基地。它也是Merz Group的一部分，该集团成立于1908年，总部设在德国法兰克福。

Learn more at US.MerzAesthetics.com..

在US.MerzAesthetics.com了解更多信息。。

To earn exclusive rewards, bonuses, and discounts on Merz Aesthetics’ portfolio of treatments, join the Xperience+ Rewards Program. To learn more about Xperience+, visit www.xperiencemerz.com.

为了获得Merz Aesthetics治疗组合的独家奖励，奖金和折扣，请加入Xperience+奖励计划。要了解有关Xperience+的更多信息，请访问www.xperiencemerz.com。

BELOTERO BALANCE (+) Important Consumer Safety Information

BELOTERO BALANCE（+）重要的消费者安全信息

What is BELOTERO BALANCE® (+)?

什么是BeloteroBalance®（+）？

BELOTERO BALANCE is a prescription injection that is approved 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) and improve the appearance of under-eye hollows in adults over the age of 21.

BELOTERO BALANCE是一种处方注射剂，被批准用于暂时平滑并填充中度至重度鼻唇沟（从鼻子侧面到嘴角的褶皱或皱纹）并改善眼睛下方的外观21岁以上成年人的空洞。

Who should not use BELOTERO BALANCE?

谁不应该使用BELOTERO余额？

BELOTERO BALANCE should not be used in patients with a history of or presence of multiple or severe allergies, including those with a history of anaphylaxis. BELOTERO BALANCE should not be used in patients with allergies to gram-positive bacterial proteins.

BELOTERO平衡不应用于有多种或严重过敏史或存在多种或严重过敏史的患者，包括有过敏史的患者。BELOTERO平衡不应用于对革兰氏阳性细菌蛋白过敏的患者。

What is the most important information I should know about BELOTERO BALANCE?

什么是我应该知道的关于BELOTERO平衡的最重要的信息？

Introduction of BELOTERO BALANCE into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft tissue fillers, for example inject the product slowly and apply the least amount of pressure necessary. Rare but serious adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis, and damage to underlying facial structures.

将BELOTERO平衡引入脉管系统可能导致栓塞，血管闭塞，局部缺血或梗塞。注射软组织填充剂时要格外小心，例如缓慢注射产品并施加最少量的压力。已经报道了与血管内注射面部软组织填充剂相关的罕见但严重的不良事件，包括暂时性或永久性视力障碍，失明，脑缺血或脑出血，导致中风，皮肤坏死和下面的面部结构损伤。

Immediately stop the injection if patient exhibits any of the following symptoms, including changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and possibly evaluation by an appropriate health care practitioner specialist should an intravascular injection occur..

如果患者出现以下任何症状，包括视力改变，中风迹象，皮肤变白或手术过程中或手术后不久出现异常疼痛，请立即停止注射。如果发生血管内注射，患者应及时就医，并可能由适当的医疗保健从业者进行评估。。

As with all events that involve an injection through the skin, there is a risk of infection. Laser treatments or chemical peels or any other treatments that affect the skin can increase the risk of infection. Do not use BELOTERO BALANCE if you have a skin inflammation or a skin infection. Do not use until the infection is healed..

与所有涉及通过皮肤注射的事件一样，存在感染风险。激光治疗或化学剥离或任何其他影响皮肤的治疗都会增加感染的风险。如果您有皮肤炎症或皮肤感染，请勿使用BELOTERO天平。在感染愈合之前不要使用。。

Patients getting BELOTERO BALANCE may have an injection site reaction. These reactions can include inflammation and usually last less than seven days.

获得BELOTERO平衡的患者可能有注射部位反应。这些反应可能包括炎症，通常持续不到七天。

For approximately 24 hours after treatment, avoid:

治疗后约24小时，避免：

strenuous activity

剧烈的活动

extensive sun or heat exposure

广泛的阳光或热量照射

aspirin or non-steroidal anti-inflammatory drugs

阿司匹林或非甾体类抗炎药

alcoholic beverages

酒精饮料

Exposure to any of the above can cause temporary redness, swelling, and/or itching at the injection site.

暴露于上述任何一种都可能导致注射部位暂时发红，肿胀和/或瘙痒。

It is not known how BELOTERO BALANCE will work in areas of the face other than the smile lines. It is not known how BELOTERO BALANCE will work in women who are pregnant or breastfeeding or people who are less than 21 years of age.

不知道BELOTERO平衡将如何在微笑线以外的面部区域工作。目前尚不清楚BELOTERO BALANCE如何在怀孕或哺乳期妇女或21岁以下的人群中发挥作用。

What should I tell my doctor before injections with BELOTERO BALANCE?

在注射BELOTERO BALANCE之前，我应该告诉我的医生什么？

Tell your doctor if you are taking medicines that affect blood clotting, like aspirin, an NSAID or warfarin. These medicines may put you at an increased risk of bruising or bleeding at the treatment site. Tell your doctor if you have a skin reaction like cold sores, cysts, pimples, rashes, hives, or an infection.

告诉你的医生你是否正在服用影响凝血的药物，如阿司匹林，非甾体抗炎药或华法林。这些药物可能会增加治疗部位瘀伤或出血的风险。如果您有皮肤反应，如唇疱疹，囊肿，皮疹，皮疹，荨麻疹或感染，请告诉您的医生。

Treatment with BELOTERO BALANCE should be delayed until the reaction goes away. Tell your doctor if you are taking medicines that affect your immune system..

应延迟使用BELOTERO平衡治疗直至反应消失。告诉你的医生，如果你正在服用影响你免疫系统的药物。。

What are the most common adverse events seen with BELOTERO BALANCE?

贝洛特罗平衡最常见的不良事件是什么？

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 side effects that have occurred in clinical studies of BELOTERO BALANCE include headache, swelling of the side of the nose, moderate cold sore, lip numbness, and lip dryness.

在BELOTERO平衡的临床研究中发现的最常见的不良事件是肿胀，瘀伤，发红，皮肤硬化，疼痛，颜色改变或瘙痒。在BELOTERO平衡的临床研究中发生的其他副作用包括头痛，鼻子侧面肿胀，中度感冒，唇部麻木和唇部干燥。

Side effects were often mild to moderate and often resolved within 7 days..

副作用通常为轻度至中度，通常在7天内消退。。

Delayed-onset inflammation near the site of injection is one of the known adverse events associated with dermal fillers. Cases of delayed-onset inflammation have been reported to occur at the treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, the reported inflammation was responsive to treatment or resolved on its own..

注射部位附近的迟发性炎症是与皮肤填充物相关的已知不良事件之一。据报道，在病毒或细菌性疾病或感染，疫苗接种或牙科手术后，在治疗部位发生迟发性炎症的病例。通常，报告的炎症对治疗有反应或自行解决。。

Information on adverse events from post-market surveillance of BELOTORO BALANCE are included in the Package Insert (PI) and Patient Information Guide (PIG) based on an assessment of seriousness and potential causal relationship to BELOTERO BALANCE.

根据对BELOTORO BALANCE的严重性和潜在因果关系的评估，包装说明书（PI）和患者信息指南（PIG）中包含有关BELOTORO BALANCE上市后监测不良事件的信息。

Please see the PI and PIG available on www.belotero.com for a complete list of these events.

请参阅www.belotero.com上的PI和PIG以获取这些事件的完整列表。

Important: For full safety information, please visit www.belotero.com or call MyMerz Solutions at 1-844-469-6379 or by email AxUS-adverse.events@merz.com.

重要提示：有关完整的安全信息，请访问www.belotero.com或致电1-844-469-6379或通过电子邮件致电MyMerz SolutionsAxUS-adverse.events@merz.com.

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