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)--Galderma (SWX:GALD), the pure-play dermatology category leader, announced today results from its new phase IIIb RELAX clinical trial demonstrating the rapid onset and the long-lasting duration of aesthetic efficacy, as well as high patient satisfaction and increased confidence, using a single-dose of RelabotulinumtoxinA (Relfydess) to treat frown lines (glabellar lines).

)--纯皮肤病学领域的领头羊Galderma（SWX:GALD）今天宣布了其新的IIIb期RELAX临床试验的结果，该试验证明了使用单剂量的RelabotulinumtoxinA（Relfydess）治疗皱眉线（眉间线）的快速起效和持久的美学效果，以及高患者满意度和增加的信心。

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. Galderma’s analysis was presented at the International Master Course on Aging Science (IMCAS) 2025 annual congress, held in Paris from January 30 to February 1, 2025.

高德玛（Galderma）的分析发表在2025年1月30日至2月1日在巴黎举行的国际老龄科学硕士课程（IMCAS）2025年年度大会上。

Developed and manufactured by Galderma, RelabotulinumtoxinA is the first and only ready-to-use liquid neuromodulator created with PEARL Technology that is designed to preserve molecule integrity to deliver a highly active, innovative, complex-free molecule

RelabotulinumtoxinA由Galderma开发和制造，是第一个也是唯一一个使用珍珠技术创建的即用型液体神经调节剂，旨在保持分子完整性，以提供高活性，创新，无复杂的分子

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Previously announced data from the phase III READY clinical trial program demonstrated rapid onset as soon as Day 1 (reported by up to 39% of subjects) and long-lasting efficacy for 6 months (maintained by up to 75% of subjects) when using RelabotulinumtoxinA to treat frown lines and crow’s feet (lateral canthal lines).

先前公布的来自III期READY临床试验计划的数据显示，当使用RelabotulinumtoxinA治疗皱眉线和鱼尾纹（外can线）时，第一天（高达39%的受试者报告）起效迅速，持续6个月（高达75%的受试者维持）的长期疗效。

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“We are proud to share our latest RelabotulinumtoxinA data, which reaffirms the sustained clinical effect and patient satisfaction observed in our READY clinical trial program. These findings, together with our proprietary PEARL Technology, reinforce RelabotulinumtoxinA as a safe, effective, and innovative treatment option, and uphold Galderma’s position at the forefront of aesthetic advancements.”.

“我们很自豪地分享我们最新的RelabotulinumtoxinA数据，这些数据重申了我们READY临床试验计划中观察到的持续临床效果和患者满意度。这些发现与我们专有的PEARL技术一起，强化了RelabotulinumtoxinA作为一种安全，有效和创新的治疗选择，并维护了Galderma在美学进步中的前沿地位。”。

BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D.

BALDO SCASSELLATI SFORZOLINI，医学博士，哲学博士。

GLOBAL HEAD OF R&D

GALDERMA

硬皮病

RELAX is a phase IIIb, multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the long-lasting efficacy and satisfaction of RelabotulinumtoxinA in 132 adults with moderate-to-severe frown lines over a 12-month period

RELAX是一项IIIb期、多中心、随机、双盲、安慰剂对照临床试验，旨在评估132名中度至重度皱眉纹成年人在12个月内的长期疗效和满意度

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Results supported a fast onset of aesthetic improvement at Day 1 (40%; subject-reported) and a duration of effect through 6 months

结果支持在第1天快速开始美学改善（40%；受试者报告），并持续6个月

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Subject satisfaction with treatment and appearance was also high, with 92% of subjects satisfied with treatment outcome at Month 1, 69% satisfied at Month 6, and 60% still satisfied at Month 12

受试者对治疗和外观的满意度也很高，92%的受试者在第1个月对治疗结果满意，69%在第6个月满意，60%在第12个月仍然满意

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Furthermore, at both Month 6 and at Month 12, more than 50% of subjects reported that they had increased self-confidence and looked great for their age, highlighting sustained benefits of RelabotulinumtoxinA over time

此外，在第6个月和第12个月，超过50%的受试者报告说，他们增强了自信心，看起来很适合他们的年龄，突出了随着时间的推移，RelabotulinumtoxinA的持续益处

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Investigators reported high rates of ≥1-grade improvement from baseline, with the highest responder rates at Month 1 (98%), and improvement in GL severity maintained through Month 6 (57%) and Month 9 (28%). RelabotulinumtoxinA continues to be well tolerated with no treatment-related serious adverse events.

研究人员报告说，与基线相比，≥1级改善率很高，第1个月的应答率最高（98%），并且在第6个月（57%）和第9个月（28%）维持GL严重程度的改善。RelabotulinumtoxinA仍然具有良好的耐受性，没有与治疗相关的严重不良事件。

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“I’m excited to see the continued benefits of RelabotulinumtoxinA highlighted in the RELAX study, in my practice. With onset from Day 1 coupled with sustained efficacy and high satisfaction for 6 months, healthcare professionals will be able to address a real need from patients, by offering them the fast acting and long-lasting results they desire, in an easy-to-use liquid formulation, with two treatments a year.”.

“在我的实践中，我很高兴看到RELAX研究中强调的RelabotulinumtoxinA的持续益处。从第1天开始，再加上持续6个月的持续疗效和高满意度，医疗保健专业人员将能够满足患者的真正需求，以一种易于使用的液体配方，每年两次治疗，为他们提供他们想要的快速有效和持久的结果。”。

GLYNIS ABLON, M.D., F.A.A.D.

GLYNIS ABLON，医学博士，F.A.A.D。

ASSOCIATE CLINICAL PROFESSOR

临床副教授

UNIVERSITY OF CALIFORNIA, LOS ANGELES

加利福尼亚大学洛杉矶分校

Following the successful completion of the European Decentralized Procedure, resulting in a positive decision for the use of Relfydess (RelabotulinumtoxinA), Galderma already received national approvals in 14 European countries, as well as a marketing authorization from Australia’s Therapeutic Goods Administration and the Medicines and Healthcare products Regulatory Agency in the UK..

在成功完成欧洲分权程序后，对使用Relfydess（RelabotulinumtoxinA）做出了积极的决定，Galderma已经在14个欧洲国家获得了国家批准，并获得了澳大利亚治疗用品管理局和英国药品和保健品管理局的上市授权。。

More details on Galderma’s scientific presentations at IMCAS can be found

有关Galderma在IMCAS上的科学演讲的更多详细信息，请参见

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About RelabotulinumtoxinA

再肉毒杆菌毒素A

Pioneered by Galderma, RelabotulinumtoxinA is the first and only ready-to-use liquid neuromodulator created with PEARL Technology that is designed to preserve molecule integrity

由Galderma开创的RelabotulinumtoxinA是第一个也是唯一一个使用珍珠技术创建的液体神经调节剂，旨在保持分子完整性

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PEARL Technology is designed to deliver a highly active, innovative, complex-free molecule, with up to 39% of patients seeing effects from day one and up to 75% of patients maintaining improvements for 6 Months

PEARL技术旨在提供一种高度活跃、创新、无复杂的分子，高达39%的患者从第一天开始就有效果，高达75%的患者在6个月内保持改善

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RelabotulinumtoxinA is optimized for simple volumetric dosing, without reconstitution, to increase ease-of-use and help ensure consistent dose/volume every time

RelabotulinumtoxinA针对简单的体积给药进行了优化，无需重建，以增加使用的便利性，并有助于确保每次剂量/体积一致

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. It was entirely developed and manufactured by Galderma to expand its neuromodulator portfolio as part of the broadest Injectable Aesthetics portfolio on the market.

。它完全由Galderma开发和制造，以扩大其神经调节剂组合，作为市场上最广泛的可注射美学组合的一部分。

About Galderma

关于Galderma

Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology.

Galderma（六：GALD）是纯粹的皮肤病学类别的领导者，目前在大约90个国家/地区。我们通过注射美学、皮肤科皮肤护理和治疗性皮肤病学，提供创新、科学的优质旗舰品牌和服务组合，涵盖快速增长的皮肤病学市场的所有领域。

Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story.

自1981年成立以来，我们一直专注于人体最大的器官-皮肤-与医疗保健专业人员合作，以优异的效果满足个人消费者和患者的需求。因为我们了解我们所处的皮肤塑造了我们的生活，所以我们正在为每一个皮肤故事推进皮肤病学。

For more information: .

有关详细信息：。

www.galderma.com

www.galderma.com

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References:

参考文献：

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Prather HB, et al. Efficacy and safety of a novel formulation liquid botulinum toxin, RelabotulinumtoxinA, when used for combination treatment of glabellar and lateral canthal lines. E-poster presented at: ASDS 2024; October 17-20, 2024; Orlando, FL

Prather HB等人。一种新型配方液体肉毒杆菌毒素RelabotulinumtoxinA用于联合治疗眉间和外眦线的疗效和安全性。电子海报发布于：ASDS 2024；2024年10月17日至20日；佛罗里达州奥兰多

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Ibrahim SF, et al. RelaBoNT-A treatment of glabellar lines and lateral canthal lines across different ethnicity and race: Pooled data from three phase III studies. E-poster presented at: ASDS 2024; October 17-20, 2024; Orlando, FL

Ibrahim SF等人。RelaBoNT-跨越不同种族和种族的眉间线和外can线的治疗：来自三项III期研究的汇总数据。电子海报发布于：ASDS 2024；2024年10月17日至20日；佛罗里达州奥兰多

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Sundberg AL and Stahl U. Relabotulinum toxin - a novel, high purity BoNT-A1 in liquid formulation. Presented at: TOXINS 2021; Jan 16-17, 2021; virtual meeting

Sundberg AL和Stahl U.Relabotulinum毒素-一种新型的高纯度BoNT-A1液体制剂。发表于：毒素2021；2021年1月16日至17日；虚拟会议

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Do M, et al. Purification process of a complex-free highly purified botulinum neurotoxin type A1 (BoNT-A1) - relabotulinumtoxinA. Presented at: TOXINS 2022; July 27-30, 2022; New Orleans, LA

Do M等人。不含复合物的高纯度肉毒杆菌神经毒素A1型（BoNT-A1）-肉毒杆菌毒素a的纯化过程。提交时间：TOXINS 2022；2022年7月27日至30日；新奥尔良，洛杉矶

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Persson C, et al. Patient and Investigator Treatment Experience with Ready-to-Use AbobotulinumtoxinA Solution Versus Powder BotulinumtoxinA for Treatment of Glabellar Lines. Abstract presented at TOXINS 2024; Jan 17-20, 2024, Berlin

Persson C等人。患者和研究者使用即用型AbobotulinumtoxinA溶液与粉状肉毒杆菌毒素治疗眉间线的治疗经验。摘要发表于毒素2024；2024年1月17日至20日，柏林

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Based on a literature search conducted in May 2023 across PuBMED, clinicaltrials.gov, and euDRACT

基于2023年5月在PuBMED、clinicaltrials.gov和euDRACT进行的文献检索

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Galderma. Data on file. Clinical Study Report for Protocol QM111: RELAX. Galderma Laboratories

。文件中的数据。方案QM111的临床研究报告：放松。高德玛实验室