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
- 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
- 發表在《美容外科雜誌》上的這篇文章支持在2023年ASDS年會上發表的暫時改善中度至重度眉間紋外觀的安全性和有效期限
- 數據顯示，基於≥1分的眉間線量表（GLS）改善並使用全球美學改善量表恢復到基準值，持續時間爲26周或6個月
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.
專注於建立消費品牌美學組合的高性能美容公司Evolus, Inc.（納斯達克股票代碼：EOLS）今天宣佈，《美容外科雜誌》已經公佈了40U Jeuveau（Prabotulinumtoxina-XVFS）2期研究的安全性和效果持續時間，該研究用於治療成人患者的中度至重度眉間線。
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.
這項 “超強度” 眉間系研究是一項多中心、雙盲、隨機、2期試驗，對150名患者進行長達12個月的跟蹤或直到患者失去矯正爲止。該研究有三個手臂：Jeuveau Extra-Strength 40U和兩個主動對照組，即肉毒桿菌毒素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.
療效結果顯示，在提供的多個指標中，療效持續了26周或6個月，包括患者在治療後恢復基準GLS分數所需的時間、GLS改善至少一分的患者的效果持續時間，以及患者使用全球美學改善量表恢復基線所需的時間。所有三個組的安全性概況相似，總體而言，88.9％的不良事件被評爲輕度，未發現嚴重的不良事件。
"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首席醫學官兼研發負責人魯伊·阿維拉爾博士說：“該出版物提供了研究設計的詳細信息以及Jeuveau超強研究的2期療效和安全性數據，使所有人都能獲得這些數據。”“該研究證實了增加劑量與延長持續時間之間的相關性，同時保持了相似的安全性，大多數不良事件被評爲輕度。”
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獲准暫時改善65歲以下成年人眉毛之間出現的中度至重度垂直線條（眉間紋），可暫時改善眉毛之間出現的中度至重度垂直線條。通過公司的透明度臨床項目，Jeuveau被臨床證明可以暫時改善成人的中度至重度眉間線或 “11歲”，其中包括針對肉毒桿菌毒素的最大規模的正面交鋒關鍵研究。該產品獲准以Jeuveau品牌在美國銷售，並以Nuceiva品牌在歐洲和加拿大銷售，並於2023年1月在澳大利亞獲得監管部門的批准。
About "Extra-Strength" Glabellar Line Study
關於 “Extra-Strength” Glabellar線研究
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研究是一項多中心、雙盲、隨機試驗，對150名患者進行了跟蹤，直到他們失去了矯正爲止，或者在五個研究地點進行了長達12個月的跟蹤。該研究包括兩種活性對照組——目前批准的20個單位的Jeuveau和20個單位的肉毒桿菌毒素——除了評估安全性、療效和效果持續時間外，還將它們與40個單位的Jeuveau進行了比較。
譯文內容由第三人軟體翻譯。