Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio, today announced that the U.S. Food and Drug Administration (FDA) has approved Evolysse

Evolus, Inc.专注于构建美学组合的性能美容公司（纳斯达克：EOLS）今天宣布，美国食品和药物管理局（FDA）已批准Evolysse

Smooth injectable hyaluronic acid (HA) gels, the first two products in the Evolysse

光滑可注射透明质酸（HA）凝胶，Evolysse的前两种产品

collection. These approvals mark Evolus’ entry into the U.S. HA dermal filler market and solidifies the company’s position as a multi-product innovator in aesthetics, expanding Evolus’ total addressable market by 78% to approximately $6 billion

收藏。这些批准标志着Evolus进入美国HA真皮填充物市场，巩固了公司作为美学多产品创新者的地位，将Evolus的总目标市场扩大了78%，达到约60亿美元

“This milestone represents an exciting new chapter in our long-term strategy to expand our portfolio and transition from a single-product company to a multi-product innovator, strengthening our leadership in performance beauty,” said David Moatazedi, President and Chief Executive Officer of Evolus. “Evolysse.

Evolus总裁兼首席执行官David Moatazedi表示：“这一里程碑标志着我们的长期战略翻开了令人兴奋的新篇章，我们将扩大投资组合，从单一产品公司过渡到多产品创新者，从而加强我们在性能美方面的领导地位。”。。

Smooth represent the first major technological breakthrough in HA dermal fillers in a decade, offering our customers and consumers a new standard in performance and innovation. The launch of these products is a catalyst in our growth as we are focused on achieving at least $700 million in net revenue and non-GAAP operating income margin.

Smooth代表了十年来HA真皮填充剂的首次重大技术突破，为我们的客户和消费者提供了性能和创新的新标准。这些产品的推出是我们增长的催化剂，因为我们专注于实现至少7亿美元的净收入和非GAAP营业收入利润率。

of at least 20% by 2028.”

到2028年至少达到20%。”

Evolus plans to launch Evolysse

Evolus计划推出Evolysse

Smooth in the U.S. market in Q2 2025. This launch will leverage Evolus’ scalable cash-pay business model and existing digital infrastructure, creating tremendous synergy with the company’s fast-growing neurotoxin business and driving significant value for both customers and consumers.

2025年第二季度美国市场平稳。此次发布将利用Evolus可扩展的现金支付业务模式和现有的数字基础设施，与公司快速增长的神经毒素业务产生巨大的协同作用，并为客户和消费者带来巨大的价值。

Smooth are part of a collection

平滑是系列的一部分

of injectable HA gels designed by Symatese, which utilizes innovative Cold-X

Symatese设计的可注射HA凝胶，采用创新的Cold-X

technology that is designed to better preserve the natural structure of the HA molecule for long-lasting, natural-looking results. The commercial launch of these first two injectable HA gels in 2025 will be followed by Evolysse

该技术旨在更好地保留HA分子的天然结构，以获得持久，自然的效果。2025年，前两种可注射HA凝胶将在商业上推出，随后将推出Evolysse

“We are proud to partner with Evolus in bringing the Evolysse

“我们很荣幸与Evolus合作推出Evolysse

collection of injectable HA gels to the U.S. market. With decades of experience in biomaterial science and aesthetics, Symatese has a strong legacy of developing innovative aesthetic products that meet the evolving needs of practitioners and their patients. With one of the largest clinical trial programs undertaken for an injectable HA technology, Evolysse.

向美国市场收集可注射HA凝胶。凭借数十年的生物材料科学和美学经验，Symatese在开发创新美学产品方面拥有丰富的遗产，这些产品可以满足从业者及其患者不断变化的需求。Evolysse是可注射HA技术最大的临床试验项目之一。

products are being evaluated for safety and effectiveness in over 2,000 patients globally,” said Jean-Paul Gérardin, Chief Executive Officer of Symatese.

Symatese首席执行官Jean-Paul Gérardin表示：“全球2000多名患者正在评估产品的安全性和有效性。”。

Dr. Rui Avelar, Evolus Chief Medical Officer and Head of R&D, added, “The FDA approval of Evolysse

Evolus首席医疗官兼研发主管Rui Avelar博士补充道：“FDA批准Evolysse

Smooth reflects our commitment to bringing high-quality, innovative aesthetic products to market. These additions to our portfolio reinforce Evolus’ dedication to the highest standards of patient safety and efficacy. With the introduction of Cold-X

平滑体现了我们致力于将高质量、创新的美学产品推向市场。这些对我们产品组合的补充强化了Evolus对患者安全性和有效性最高标准的承诺。随着Cold-X的引入

offers a differentiated approach to the dermal filler category, providing healthcare practitioners with new options to address the unique needs of their patients with precision and confidence.”

为皮肤填充剂类别提供了一种差异化的方法，为医疗保健从业人员提供了新的选择，以精确和自信地满足患者的独特需求。”

Dr. Michael Kaminer, MD, lead investigator for the U.S. NLF pivotal study and an internationally recognized expert in cosmetic surgery, commented, “The Evolysse

医学博士迈克尔·卡米纳博士是美国NLF关键研究的首席研究员，也是国际公认的整容手术专家，他评论道：“Evolysse

Smooth injectable HA gels demonstrated impressive safety, efficacy, and versatility, with the unique property of being injectable at various depths in the skin. These products allow practitioners to achieve precise, natural-looking results, while delivering high patient satisfaction with their effectiveness and longevity.” The U.S.

光滑的可注射HA凝胶表现出令人印象深刻的安全性，有效性和多功能性，具有可在皮肤不同深度注射的独特特性。这些产品可以让从业者获得精确、自然的效果，同时让患者对其有效性和寿命感到高度满意。”美国。

Nasolabial Fold (NLF) pivotal study for Evolysse.

鼻唇沟（NLF）对Evolysse的关键研究。

Smooth included 140 patients in a double-blind, prospective, randomized, active-control split-face trial. Seventy patients were treated with each product, with investigators performing the procedures, evaluating outcomes, and following a rigorous clinical protocol.

Smooth在一项双盲，前瞻性，随机，主动对照的裂面试验中纳入了140名患者。70名患者接受了每种产品的治疗，研究人员进行了手术，评估了结果，并遵循了严格的临床方案。

Smooth were evaluated in a head-to-head study with Restylane

在与Restylane的头对头研究中评估了平滑

-L. Both products met the primary endpoint of non-inferiority

-L。两种产品都达到了非劣效性的主要终点

, and both the confidence intervals as well as the corresponding p-values (<0.001) demonstrated statistical superiority

，置信区间和相应的p值（<0.001）均显示出统计学优势

As assessed by the live, blinded investigators, Evolysse

根据现场盲法调查人员Evolysse的评估

Form showed statistically significant differences

表格显示出统计学上的显着差异

compared to Restylane-L at all measured timepoints for the entire 12-month study period. Evolysse

在整个12个月的研究期间，在所有测量的时间点与Restylane-L进行比较。进化论

Smooth showed statistically significant differences

平滑显示出统计学上的显着差异

compared to Restylane-L at 6 and 9 months – even though 20% more Restylane-L was used

在 6 个月和 9 个月时，与 Restylane-L 相比，尽管 Restylane-L 的使用量增加了 20%。

In the head-to-head clinical study versus Restylane-L, the safety profile of Evolysse

在与Restylane-L的头对头临床研究中，Evolysse的安全性

Smooth was similar to the control, with most adverse events being mild to moderate. There were no treatment-related serious adverse events, and no delayed-onset nodules were observed.

Smooth与对照组相似，大多数不良事件为轻度至中度。没有治疗相关的严重不良事件，也没有观察到延迟发作的结节。

Evolus previously announced that EU Medical Device Regulation (MDR) approval was received for four unique injectable hyaluronic acid (HA) gels under the brand name Estyme

Evolus先前宣布，四种独特的可注射透明质酸（HA）凝胶（品牌为Estyme）已获得欧盟医疗器械法规（MDR）的批准

(pronounced “esteem”), reflecting the product’s compliance with the highest regulatory standards. Evolus is also introducing Estyme

（发音为“尊重”），反映产品符合最高监管标准。Evolus也引入了Estyme

through a limited experience program with select physician partners in Europe, to continue to expand global experience with the product’s performance. A broader European launch remains on track for the second half of 2025, further expanding Evolus’ footprint into the global dermal filler market and reinforcing its position as a leader in performance beauty..

通过与欧洲精选医师合作伙伴的有限体验计划，继续扩大产品性能的全球体验。2025年下半年，Evolus将在欧洲推出更广泛的产品，这将进一步扩大Evolus在全球真皮填充物市场的足迹，并巩固其在性能美容领域的领先地位。。

About Evolus, Inc.

关于Evolus，Inc。

Evolus (NASDAQ: EOLS) is a global performance beauty company redefining the aesthetic injectable market for the next generation of beauty consumers through its unique, customer-centric business model and innovative digital platform. Our mission is to become a global leader in aesthetics anchored by our flagship products: Jeuveau.

Evolus（纳斯达克股票代码：EOLS）是一家全球性能美容公司，通过其独特的、以客户为中心的商业模式和创新的数字平台，为下一代美容消费者重新定义了美容注射市场。我们的使命是通过我们的旗舰产品Jeuveau成为美学领域的全球领导者。