Company announces Phase 3 READY program of its proprietary, novel, liquid formulation of an investigational botulinum toxin for the treatment of glabellar lines and lateral canthal lines is fully enrolled
LAUSANNE, Switzerland-Saturday 10 October 2020 [ AETOS Wire ]
(BUSINESS WIRE)-- Galderma today announced the presentation of data from clinical trials of its aesthetic solutions and pipeline in five abstracts at the virtual American Society for Dermatologic Surgery (ASDS) 2020 Annual Meeting. The company also announced that it has completed patient enrollment in several clinical trials supporting a Phase 3 program of relabotulinumtoxinA (QM1114), its proprietary novel, ready-to-use, liquid formulation of investigational botulinum toxin, for the treatment of glabellar lines and lateral canthal lines. The Phase 3 program, called READY (RElabotulinumtoxin Aesthetic Development studY), enrolled over 1,900 patients across 60 sites in the United States and Canada in four clinical trials – three multi-center, randomized, double-blind, placebo-controlled studies and one long-term open-label study.
RelabotulinumtoxinA clinical trials will evaluate rapid onset, long duration, and additional patient measures as part of the large clinical program for this next generation botulinum toxin. The liquid formulation will be ready to use upon arrival and will not require in-office reconstitution before administration, it will reduce preparation time, and has the potential to increase accuracy and improve patient outcomes, in contrast with current treatments that require reconstitution by clinicians before administration. Derived from Galderma’s proprietary strain of Clostridium botulinum bacteria and created using an animal-origin free process, relabotulinumtoxinA will be manufactured in Galderma’s new state-of-the-art Center of Excellence in Aesthetics in Uppsala, Sweden.
“Our patient-first approach to aesthetics innovation has resulted in seven FDA approvals over the last six years. Based on the success of the latest outcomes we’ve shared today, and our continued work to bring patients safe and long-lasting results, we also expect to receive six more approvals in the next three years,” said Dr. Flemming Ornskov, MD, MPH, Chief Executive Officer, Galderma. “The launch of Restylane® Kysse earlier this year has shown the strong demand for new aesthetic solutions to improve the patient and provider experience throughout 2020. Our robust Phase 3 and Phase 4 clinical programs have helped propel the launch of Restylane® Kysse, and the data presented today underscores our relentless focus on meeting the needs of our customers.”
Galderma’s Data Presentations at ASDS 2020
During the ASDS meeting, Galderma will present clinical research findings across its neurotoxin and dermal fillers portfolio. The company’s oral and poster presentations will highlight results from the DREAM (Dysport Real-world Evaluation and Measured satisfaction) study of Dysport® (abobotulinumtoxinA) for Injection*, which demonstrated high levels of patient satisfaction and natural-looking results with only two treatments per year1. Additionally, Phase 3 clinical research showed that Restylane® Defyne was effective for correction of chin retrusion and was associated with a high degree of patient satisfaction, and Restylane® Kysse was shown to be effective for lip augmentation over a 48-week treatment period with a high degree of patient satisfaction. In a Phase 4 study of Restylane® Kysse, both subjects and their partners were satisfied with the subjects’ lips after treatment.2,3
“The results of the DREAM study showing the long duration of Dysport and high patient satisfaction with treatments given twice a year are especially important as it’s the first toxin to showcase this extended patient satisfaction benefit,”1 said Dr. Carolyn Jacob, MD, FAAD, Founder and Medical Director of Chicago Cosmetic Surgery and Dermatology and an investigator for the DREAM study. “The study data showing that 95% of patients were satisfied or highly satisfied with the aesthetic results of treating the lines between their eyebrows every six months for a year with Dysport should give patients and aesthetic specialists confidence in this treatment regimen.”1
Details about Galderma’s presentations are as follows:
A randomized, no-treatment controlled, evaluator-blinded, multi-center phase 3 study to evaluate the effectiveness and safety of HARD in the chin for augmentation and correction of chin retrusion – Dr. Anne Chapas (Oral Abstract: Friday October 9, 9:09-9:12 a.m.)
A randomized, controlled, evaluator-blinded, multicenter study to evaluate the effectiveness and safety of HAkys versus a control in augmentation of soft tissue fullness of the lip – Dr. Sue Ellen Cox (Oral Abstract: Friday October 9, 9:03-9:06 a.m.)
Post marketing study to evaluate lip enhancement, naturalness, and satisfaction of both subject and partner after treatment with HARK – Dr. Vince Bertucci (Oral Abstracts #5: Saturday, October 10, 11:30-11:33 a.m.)
Subjects are highly satisfied with two treatments of abobotulinumtoxinA a year: results from multi-center, year-long, longitudinal study – Dr. Ava Shamban (e-poster)
A randomized, evaluator-blinded, multi-center phase 3 study to evaluate safety and effectiveness of a biostimulatory poly-l-lactic acid injectable implant after changes in reconstitution – Dr. Melanie Palm (e-poster)
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 neuromuscular disorder indications in countries around the world. For more information on Ipsen, visit www.ipsen.com.
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 http://www.galderma.com/.
Follow Galderma on Instagram at @GaldermaAesthetics
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To learn more about serious but rare side effects and full Important Safety Information, visit www.RestylaneUSA.com.
*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.
©2020 Galderma All Rights Reserved.
1 Data on file. Study 43USD1802. Galderma, Fort Worth, TX, 2020.
2 Galderma. Clinical Study Report: Post Marketing Study to Evaluate Lip Enhancement, Naturalness and Partner/Subject Satisfaction after Treatment with Restylane® Kysse N/A Restylane Kysse 2020; 29.
3 FDA. Restylane Kysse Instructions for Use (IFU) N/A Restylane Kysse 2020.
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Investor and media relations
Christian Marcoux, M.Sc.
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Isabella Laihorinne Smedh
PR & Communications, Galderma
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