/ -- Allergan Aesthetics, an AbbVie company (NYSE: ABBV), today announced that the U.S. Food and Drug Administration (FDA) accepted for review the supplemental premarket approval (sPMA) application for SKINVIVE by JUVÉDERM® to reduce neck lines for the improvement of neck appearance. SKINVIVE by JUVÉDERM® is currently approved in the U.S.

/ -- 艾伯维公司（AbbVie，纽约证券交易所代码：ABBV）旗下的艾尔建美学今天宣布，美国食品药品监督管理局（FDA）已接受补充上市前批准（sPMA）申请，审查JUVÉDERM® 推出的SKINVIVE用于减少颈纹以改善颈部外观。JUVÉDERM® 的SKINVIVE目前已在美国获得批准。

to improve skin smoothness of the cheeks in adults over the age of 21..

改善21岁以上成人脸颊的皮肤光滑度。

'SKINVIVE by JUVÉDERM

'SKINVIVE by JUVÉDERM

is an injectable version of hyaluronic acid, a naturally occurring molecule found in the skin and important for skin hydration,' said

是透明质酸的可注射版本，透明质酸是一种天然存在于皮肤中且对皮肤保湿重要的分子，

Darin Messina

达林·梅希纳

, Ph.D., senior vice president, aesthetics R&D, AbbVie. 'The submission of SKINVIVE by JUVÉDERM

博士，高级副总裁，美学研发部门，艾伯维公司。“JUVÉDERM提交的SKINVIVE

to treat neck lines demonstrates our continued focus on developing new indications for comprehensive lower face and neck treatment as part of our market-leading portfolio of products, including BOTOX Cosmetic

治疗颈纹展示了我们持续专注于开发全面的下面部和颈部治疗的新适应症，作为我们市场领先的产品组合的一部分，包括保妥适化妆品。

and SkinMedica

和SkinMedica

Neck appearance is a top concern among people seeking aesthetic treatment, with millions of consumers considering professionally administered treatments to address their neck concerns.

脖子的外观是寻求美容治疗的人们最关心的问题之一，数百万消费者考虑通过专业治疗来解决他们的颈部问题。

SKINVIVE by JUVÉDERM

SKINVIVE by JUVÉDERM

could offer the first hyaluronic acid injectable that aims to reduce neck lines to improve neck appearance.

可能是首个旨在减少颈纹以改善颈部外观的透明质酸注射剂。

The sPMA submission is supported by data from a multicenter, evaluator-blinded, randomized controlled study evaluating the safety and effectiveness of SKINVIVE by JUVÉDERM

sPMA 提交得到了来自一项多中心、评估者盲法、随机对照研究的数据支持，该研究评估了 JUVÉDERM 的 SKINVIVE 的安全性和有效性。

in adults with moderate to severe horizontal neck lines seeking improvement in neck appearance.

在寻求改善颈部外观的中度至重度水平颈纹的成人中。

All primary and secondary endpoints were met.

所有主要和次要终点均达到。

Based on investigator assessment of horizontal neck lines, 80% of patients treated with SKINVIVE by JUVÉDERM

基于研究者对水平颈纹的评估，80% 使用 JUVÉDERM 的 SKINVIVE 治疗的患者

achieved at least a 1-grade improvement at month 1.

在第1个月至少提高了1个等级。

Nearly 90% of patients treated with SKINVIVE by JUVÉDERM

将近90%的患者使用了JUVÉDERM的SKINVIVE治疗

reported improvement in neck appearance at month 1 as assessed by the Global Aesthetic Improvement Scale.

在第1个月时，根据整体美学改善量表评估，颈部外观有所改善。

Patients treated with SKINVIVE by JUVÉDERM

使用JUVÉDERM的SKINVIVE治疗的患者

reported being significantly less bothered with the overall appearance of their neck following treatment as measured by the FACE-Q questionnaire, while patients in the control group demonstrated no significant change.

在治疗后，通过FACE-Q问卷测量，患者报告颈部整体外观的困扰显著减少，而对照组的患者则没有显示出显著变化。

Treatment-emergent adverse events for SKINVIVE by JUVÉDERM

JUVÉDERM的SKINVIVE治疗中出现的不良事件

were mild in severity and consistent with known safety profile.

严重程度较轻，与已知的安全性特征一致。

Additional data from the clinical study will be submitted for presentation at a future medical congress and for publication.

临床研究的更多数据将会被提交，以在未来的医学大会上展示和发表。

'Patients express frustration about the visible changes in their neck due to aging and sun exposure and seek non-surgical treatment options to address them,' said

“患者对他们因衰老和日晒导致的颈部明显变化表示沮丧，并寻求非手术治疗方案来解决这些问题，”

Jeanine Downie

珍妮·唐尼

, MD, FAAD, board-certified dermatologist and clinical investigator. 'SKINVIVE by JUVÉDERM® may offer another tool for patients exploring their aesthetics treatment journey beyond the face.'

医学博士，FAAD，经委员会认证的皮肤科医生和临床研究员。'SKINVIVE by JUVÉDERM® 可能为探索面部以外美学治疗旅程的患者提供了另一种工具。'

SKINVIVE by JUVÉDERM® Injectable Gel Important Information

SKINVIVE by JUVÉDERM® 注射凝胶重要信息

APPROVED USES

批准的用途

SKINVIVE by JUVÉDERM® Injectable Gel is an intradermal injection to improve facial skin smoothness of the cheeks in adults over the age of 21.

SKINVIVE by JUVÉDERM® 注射凝胶是一种真皮内注射剂，用于改善21岁以上成人脸颊部位的面部皮肤平滑度。

At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch.

在艾尔建美学，作为艾伯维公司的一部分，我们开发、制造和销售一系列领先的美学品牌和产品。我们的美学产品组合包括面部注射剂、身体塑形、整形、护肤品等。我们的目标是始终为客户提供创新、教育、卓越的服务以及对卓越的承诺，同时保持个性化关怀。

About AbbVie

关于艾伯维

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio.

艾伯维的使命是发现并提供创新药物和解决方案，以解决当今严重的健康问题，并应对未来的医疗挑战。我们力求在包括免疫学、肿瘤学、神经科学和眼科等多个关键治疗领域，以及我们艾尔建美学产品组合中的产品和服务，对人们的生活产生显著影响。