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Evolus Announces Publication Of Safety and Duration Data From Phase 2 Study for "Extra-Strength" 40U Formulation of Jeuveau

Evolus Announces Publication Of Safety and Duration Data From Phase 2 Study for "Extra-Strength" 40U Formulation of Jeuveau

Evolus 宣布发布 Jeuveau “超强度” 40U 配方的第二阶段研究的安全性和持续时间数据
Benzinga ·  04/17 16:13
  • The article published in Aesthetic Surgery Journal supports safety and duration of effect for temporary improvement in the appearance of moderate to severe glabellar lines presented at the 2023 ASDS Annual Meeting
  • Data showed duration effect of 26 weeks, or 6 months, based on a ≥ 1-point Glabellar Line Scale (GLS) improvement and return to baseline value using the Global Aesthetic Improvement Scale
  • 发表在《美容外科杂志》上的这篇文章支持在2023年ASDS年会上发表的暂时改善中度至重度眉间纹外观的安全性和有效期限
  • 数据显示,基于≥1分的眉间线量表(GLS)改善并使用全球美学改善量表恢复到基准值,持续时间为26周或6个月

Evolus, Inc. (NASDAQ:EOLS), a performance beauty company with a focus on building an aesthetic portfolio of consumer brands, today announced that the Aesthetic Surgery Journal has published the safety and duration of effect results from the Phase 2 study of 40U Jeuveau (prabotulinumtoxinA-xvfs) for the treatment of moderate to severe glabellar lines in adult patients.

专注于建立消费品牌美学组合的高性能美容公司Evolus, Inc.(纳斯达克股票代码:EOLS)今天宣布,《美容外科杂志》已经公布了40U Jeuveau(Prabotulinumtoxina-XVFS)2期研究的安全性和效果持续时间,该研究用于治疗成人患者的中度至重度眉间线。

The "extra-strength" glabellar line study is a multicenter, double-blind, randomized, Phase 2 trial following 150 patients for up to 12 months or until the patient loses their correction. The study has three arms: Jeuveau Extra-Strength 40U and two active controls, BOTOX 20U and Jeuveau 20U.

这项 “超强度” 眉间系研究是一项多中心、双盲、随机、2期试验,对150名患者进行长达12个月的跟踪或直到患者失去矫正为止。该研究有三个手臂:Jeuveau Extra-Strength 40U和两个主动对照组,即肉毒杆菌毒素20U和Jeuveau 20U。

Efficacy results demonstrated 26 weeks, or 6 months duration across the multiple metrics presented, including the time it took for patients to return to their baseline GLS score after their treatment, the duration of effect for a patient with at least a one-point GLS improvement, and the time it took a patient to return to their baseline using the Global Aesthetic Improvement Scale. The safety profile was similar across all three arms and overall, 88.9% of adverse events were rated as mild and no serious adverse events were identified.

疗效结果显示,在提供的多个指标中,疗效持续了26周或6个月,包括患者在治疗后恢复基准GLS分数所需的时间、GLS改善至少一分的患者的效果持续时间,以及患者使用全球美学改善量表恢复基线所需的时间。所有三个组的安全性概况相似,总体而言,88.9%的不良事件被评为轻度,未发现严重的不良事件。

"This publication provides the details of the study design along with the efficacy and safety data from the Phase 2 Jeuveau extra-strength study and makes it accessible to all," said Dr. Rui Avelar, MD, Chief Medical Officer and Head of R&D of Evolus. "The study confirms the correlation between increasing dose and increasing duration, while maintaining a similar safety profile, with the majority of adverse events rated as mild."

Evolus首席医学官兼研发负责人鲁伊·阿维拉尔博士说:“该出版物提供了研究设计的详细信息以及Jeuveau超强研究的2期疗效和安全性数据,使所有人都能获得这些数据。”“该研究证实了增加剂量与延长持续时间之间的相关性,同时保持了相似的安全性,大多数不良事件被评为轻度。”

Jeuveau is approved for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines) in adults below 65 years of age. Through the company's TRANSPARENCY Clinical Program, Jeuveau was clinically proven to temporarily improve moderate to severe glabellar lines or "11's" in adults and included the largest head-to-head pivotal study versus BOTOX. The product is approved for sale in the U.S. under the brand name Jeuveau and in Europe and Canada under the brand name Nuceiva and received regulatory approval in Australia in January 2023.

Jeuveau获准暂时改善65岁以下成年人眉毛之间出现的中度至重度垂直线条(眉间纹),可暂时改善眉毛之间出现的中度至重度垂直线条。通过公司的透明度临床项目,Jeuveau被临床证明可以暂时改善成人的中度至重度眉间线或 “11岁”,其中包括针对肉毒杆菌毒素的最大规模的正面交锋关键研究。该产品获准以Jeuveau品牌在美国销售,并以Nuceiva品牌在欧洲和加拿大销售,并于2023年1月在澳大利亚获得监管部门的批准。

About "Extra-Strength" Glabellar Line Study

关于 “Extra-Strength” Glabellar线研究

The "Extra-Strength" Glabellar Line Study is a multicenter, double-blind, randomized trial that followed 150 patients until they lost their correction or up to 12 months at five study sites. The study includes two active controls – the currently approved 20 units of Jeuveau and 20 units of BOTOX – which were compared to 40 units of Jeuveau in addition to evaluating the safety, efficacy, and duration of effect.

“Extra-Strength” Glabellar Line研究是一项多中心、双盲、随机试验,对150名患者进行了跟踪,直到他们失去了矫正为止,或者在五个研究地点进行了长达12个月的跟踪。该研究包括两种活性对照组——目前批准的20个单位的Jeuveau和20个单位的肉毒杆菌毒素——除了评估安全性、疗效和效果持续时间外,还将它们与40个单位的Jeuveau进行了比较。

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