GALDERMA
Galderma today announced top-line results from a Phase 2 study on the impact of dose escalation on the duration of effect and the efficacy and safety of a single dose of Dysport ® (abobotulinumtoxinA) for Injection (50U, 75U, 100U or 125U) versus placebo for the treatment of moderate to severe frown lines between the eyebrows (glabellar lines). Results showed that the study met its primary endpoint, with significantly more subjects treated with Dysport ® at all four doses achieving a composite two grade improvement responder rate than those treated with placebo at one month. Data from secondary endpoints demonstrated promising results for a potential prolonged duration of effect correlated with higher doses. Dysport ® , also marketed as Azzalure® in some countries, is a prescription injection for temporary improvement in the look of moderate to severe glabellar lines in adults less than 65 years of age.
“We are encouraged that these study results demonstrate that a single dose of Dysport ® has a rapid onset, long-lasting effect and is well tolerated,” said John H. Joseph, M.D., investigator for the study and director of The Clinical Testing Center of Beverly Hills. “At all doses tested in the trial, Dysport ® had a strong safety profile, including very few cases of eyelid ptosis.”
Phase 2 Dose-Escalating Study Design and Results
The multicenter, randomized, dose-ranging, double-blind, placebo-controlled Phase 2 study enrolled 401 subjects ages 18 to 65 with moderate to severe glabellar lines at maximum frown. Study participants were randomized 4:1 to receive a single dose of Dysport
®
(50U, the dose in the FDA-approved label, 75U, 100U or 125U) or placebo and followed for nine months. The primary objective of the study was to evaluate the efficacy of a single dose of Dysport
®
as assessed by the composite responder rate at maximum frown at one month. Secondary objectives evaluated other measures of efficacy as well as duration of treatment response, subject satisfaction, aesthetic improvement and onset of treatment response.
Top-line efficacy results showed that the study met its primary endpoint. After one month, all dose groups treated with Dysport ® showed a statistically significant composite (investigator and subject-assessed) ≥2-grade improvement when compared with placebo. Favorable results were achieved for all doses in the secondary objectives, including a ≥1-grade improvement and subject satisfaction throughout the study duration. Dysport ® was well tolerated with a similar safety profile across all doses tested. Treatment-related adverse events were mild or moderate in severity and transient, and no treatment-related serious adverse events were reported.
“This phase 2 study underscores our commitment to bring efficacious products and long-lasting results to customers,” said Baldo Scassellati Sforzolini, Global Head of Research & Development at Galderma. “Based on these encouraging safety and long-term efficacy results, as well as continued patient satisfaction, we are evaluating future clinical studies.”
About Galderma's collaboration with Ipsen
Dysport
®
(abobotulinumtoxinA) is a prescription injection for temporary improvement in the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults less than 65 years of age. Dysport
is also marketed as Azzalure®
in the EU for the treatment of glabellar lines with more than 40 million treatments in the EU and U.S. combined and with approvals in 74 countries.
Dysport
®
is manufactured by Ipsen, a global specialty-driven pharmaceutical company. Since 2009, Galderma and Ipsen have had a strategic partnership under which Galderma has promoted and distributed Ipsen's botulinum toxin type A products in aesthetic indications. The Ipsen-Galderma strategic partnership now covers China, the United States, the European Union, Australia, South Korea, Canada, Brazil, Argentina, and certain other countries. Ipsen continues to promote Dysport
®
within certain therapeutic indications in countries around the world.
For more information on Ipsen, visit www.ipsen.com
.
About Galderma
Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetic solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com/
.
# # #
Visit www.fda.gov/medwatch or call 1‐800‐FDA‐1088.
For U.S. audiences please see Dysport Full Prescribing Information including Medication Guide at DysportUSA.com .
The Dysport trademark is used under license. All trademarks are the property of their respective owners.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201117005773/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
HCLTech and Zscaler Expand Partnership for AI-Powered Security and Network Transformation16.10.2025 20:13:00 CEST | Press release
HCLTech, a leading global technology company, and Zscaler™, a leader in cloud security, announced the expansion of their strategic partnership to provide AI-powered network transformation and enhanced zero-trust security services to enterprises worldwide. Under the new partnership scope, Zscaler's Zero Trust Exchange™ platform has been integrated with HCLTech's Cybersecurity Fusion Center (CSFC) platform. HCLTech’s AI capabilities, including SecOps and Responsible AI guardrails within HCLTech AI Force and AI Foundry are key to this partnership. This collaboration aims to enhance enterprise resilience and achieve business outcomes with a cloud-first, scalable security solution. HCLTech's Universal Managed Detection and Response (UMDR) services now integrate with Zscaler Internet Access™ (ZIA™), Zscaler Private Access™ (ZPA™) and other Zscaler components, providing context-rich threat detection, advanced analytics and faster response powered by AI and automation. Other key highlights of
Beyon Cyber and Haven Sign MoU to Launch Advanced AI-Powered SOC Capabilities in the UK and Worldwide16.10.2025 19:58:00 CEST | Press release
Beyon Cyber, part of the Beyon Group and the fastest growing cyber security company in the Middle East, has signed a Memorandum of Understanding (MoU) with Haven Cyber Technologies, a global cyber security services provider and a Microsoft Solutions Partner, through its UK-based subsidiary ITC Secure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251016047852/en/ Beyon Cyber and Haven Sign MoU Under the MoU, Beyon Cyber and Haven will form a strategic partnership to revolutionize cyber security operations through the launch of advanced AI-driven Security Operations Centers (AI SOCs) in the United Kingdom and worldwide. As part of this collaboration, Haven will integrate Beyon Cyber’s cutting-edge AI SOC platform, Orryx AI, into its operations; harnessing the power of smart automation and agentic AI workflows to enhance threat detection, investigation, hunting, intelligence, and response. This partnership will enable both or
Stefanini Honored at ISG Women in Digital Awards EMEA as Natalia Chiritescu Wins Bronze Luminary for AI Leadership16.10.2025 17:23:00 CEST | Press release
Recognition underscores Stefanini’s AI-First strategy and global commitment to accelerating digital transformation through innovation and inclusion. Information Services Group (ISG) has honored Stefanini at the Women in Digital Awards in EMEA, celebrating Natalia Chiritescu. Chiritescu, Digital Solutions Center (DSC) Director for EMEA, NA, & APAC, was awarded “Bronze Luminary” in the AI Champion category recognizing AI adoption and enablement impact. The ISG Women in Digital Awards program, launched in the Americas in 2022, was expanded in 2023 to the Europe, Middle East and Africa (EMEA) and Asia Pacific regions, including India. In 2025, the global program had a total of 536 finalists and winners were announced on September. “The Women in Digital Awards aim to elevate and connect visionary women across the tech landscape. Natalia Chiritescu’s achievement is a testament to the program’s purpose: to foster collaboration, innovation, and diversity, empowering leaders to drive AI-enabled
CyberArk Named a Leader in the 2025 Gartner® Magic Quadrant™ for Privileged Access Management16.10.2025 17:06:00 CEST | Press release
CyberArk is recognized as a Leader for the seventh consecutive time.CyberArk's view is that recognition underscores the company's vision and innovation in the PAM market.CyberArk Identity Security Platform secures all identities with modern privilege controls. CyberArk (NASDAQ: CYBR), the global leader in identity security, today announced it has been named a Leader in the 2025 Gartner® Magic Quadrant™ for Privileged Access Management1. Recognized as a Leader for the seventh consecutive time, CyberArk is positioned furthest in Completeness of Vision which, from the company's standpoint, reflects CyberArk's commitment to defining the future of privilege access management (PAM), where every identity is protected with flexible as-needed access, smart AI-driven privilege controls, and unified security across both cloud and on-premises systems. The report evaluates tools that manage privileged access for both humans and machines. The CyberArk Identity Security Platform enables organizations
HistoSonics Announces Oversubscribed $250 Million Growth Financing16.10.2025 16:00:00 CEST | Press release
With backing from Peter Thiel, K5 Global, Jeff Bezos, and Wellington Management, among others, HistoSonics is positioned to expand globally across new clinical applications HistoSonics, Inc., the developer of the Edison® Histotripsy System and novel histotripsy therapy platform, today announced the closing of an oversubscribed $250 million financing led by its new ownership group and included additional investors Thiel Bio and Founders Fund, among others. The financing will support the ongoing commercial expansion of HistoSonics’ Edison System into new global markets, accelerate new clinical indications throughout the body, and strengthen operational capacity for the next phase of growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251016119331/en/ HistoSonics Non-Invasive Edison Histotripsy System Image credit: HistoSonics This funding follows the recent $2.25 billion majority stake acquisition of HistoSonics by a consor
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom