ZUG, Switzerland - Thursday, 25. January 2024
Galderma will share exciting phase III data on its novel, investigational, ready-to-use liquid botulinum toxin A, RelabotulinumtoxinA, further reinforcing its unprecedented efficacy and safety in treating frown lines and crow’s feet.1-3
Two symposia will educate on individualized treatment approaches by exploring the aesthetic lives of patients and the science behind our products, using the AART™ methodology; and our first Medical Affairs symposium will focus on skin science.
The company will present 10 research posters in total, including new data on Sculptra as we proudly celebrate its 25th anniversary.
(BUSINESS WIRE)--Galderma will be sharing the latest updates from across its broad and unparalleled portfolio at the International Master Course on Aging Science (IMCAS) World Congress 2024 from February 1-3, 2024, in Paris. The updates reinforce Galderma’s leadership in aesthetic injectables and dermatological skincare. In addition to presenting 10 research posters highlighting data from across the portfolio —including on our investigational neuromodulator RelabotulinumtoxinA — Galderma will host a number of events dedicated to addressing the real needs of physicians. This will include three symposia and several ‘Meet the Expert’ and interactive booth sessions.
“The breadth of our data and activities at IMCAS truly embodies our commitment to responding directly to the needs of healthcare professionals and patients. We’re looking forward to another opportunity to listen and learn from the aesthetics community to help us further advance our groundbreaking innovations.”
BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D.
GLOBAL HEAD OF R&D
GALDERMA
Data from our leading neuromodulator portfolio
RelabotulinumtoxinA was developed over the past 15 years as part of our ambition to expand our leadership in neuromodulation and to create an ideal neuromodulator for aesthetic use. Results from the phase III READY-1 and READY-2 studies will be presented, showing that RelabotulinumtoxinA was highly effective and well-tolerated when treating moderate to severe glabellar lines (frown lines) and lateral canthal lines (crow’s feet). Results demonstrated rapid onset as early as day one, sustained results through six months, and high patient satisfaction.1 39% and 34% of people with glabellar lines and lateral canthal lines, respectively, reported onset within one day. The median time to return to baseline line was >24 weeks (end of study) for glabellar lines and 24.7 weeks for lateral canthal lines on both investigator- and patient-assessed scales.1 Both studies had low rates of treatment-related adverse events with RelabotulinumtoxinA compared to placebo.1
The READY (RElabotulinumtoxin Aesthetic Development StudY) clinical trial program is composed of four phase III trials, which enrolled more than 1,900 participants.4-7
The data will be presented as an e-poster, displayed throughout the whole conference period at the Open Stage Library.
Showcasing our latest clinical and educational efforts
Three symposia will highlight Galderma’s innovations and science as well as educational efforts to support the aesthetics community.
Through lectures and live demonstrations, the first symposium, Our Aesthetic Lives – Pushing the Boundaries in Aesthetics, will delve into the aesthetic lives of patients and the aesthetics practitioners who treat them. It will focus on looking beyond lines and wrinkles to consider how to approach surgical cases with injectables. The event is taking place in the Amphitheatre Bleu, Level 2 on Friday, February 2, from 10:30 AM to 12:30 PM CET.
Our second symposium, Skin Science by Galderma Medical Affairs, will focus on diversity in skin health and beauty and uncover the science behind our injectables (Restylane® SKINBOOSTERS™ and Sculptra). The event is taking place in Room 351 - Level 3 on Friday, February 2, from 2:00 to 3:30 PM CET.
Finally, the AART™ of Sculptra symposium will explore how Sculptra’s applications have expanded over the last 25 years, enabling us today to understand the right patients’ profile, with the support of a holistic facial assessment tool. The event is taking place in Room 252 - Level 2 on Friday, February 2, from 4:00 to 5:00 PM CET.
We will also host a number of ‘Meet the Expert’ sessions, which will provide education on our Holistic Individualized Treatment (HIT™) approach. We will explore a range of our treatment protocols that combine different solutions from our Galderma portfolio, such as Kiss & Smile™, SHAPE UP™ and CTMP™: Cleanse, Treat, Moisturize, Protect, as well as products including ALASTIN Skincare®, Restylane® and Sculptra.
Celebrating 25 years of innovation with Sculptra
We are proud to have reached the 25th anniversary landmark for Sculptra, the first and original injectable biostimulator containing microparticles of unique PLLA-SCA™.8-11 Sculptra addresses the root causes of skin aging, stimulating the body's own collagen production to help gradually restore structural support and firmness, improving skin quality and radiance for 2 years.8-11
Building on the extensive body of evidence on Sculptra’s mode of action and proven efficacy and safety profile, we will be presenting multiple posters on Sculptra at IMCAS including positive results in non-facial areas.9-14 More details on Galderma’s scientific presentations at IMCAS can be found here.
About RelabotulinumtoxinA (QM1114)
Developed by Galderma, RelabotulinumtoxinA is a highly-active, innovative, complex-free, and ready-to-use liquid botulinum toxin A with a proprietary strain and manufactured using a unique state-of-the-art process. It is designed as a liquid, avoiding the traditional requirement to reconstitute from powder and eliminating variability, errors and risks associated with reconstitution, which would be expected to improve the consistency of results. RelabotulinumtoxinA is currently being investigated globally by Galderma, to expand its neuromodulator portfolio as part of the broadest Injectable Aesthetics portfolio on the market.
About Sculptra®
Sculptra is the first and original injectable biostimulator containing microparticles of PLLA-SCA™, which helps gradually restore the skin’s structural support and firmness, improving overall skin quality for natural-looking results for more than 2 years.8-11§ Sculptra was first approved for aesthetic use in 1999 in Europe and is currently available in more than 40 countries globally.
§Clinical study ended at 96 weeks (2 years)
About Galderma
Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market though Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.
References:
1.Gold, M, et al. Ph III efficacy and safety data on relabotulinumtoxinA, an investigational liquid botulinum toxin for treatment of glabellar or lateral canthal lines. Abstract presented at IMCAS 2024.
2.Solish, N, et al. Treatment of Moderate-to-Severe Glabellar Lines with RelabotulinumtoxinA, an Investigational Liquid Botulinum Toxin: Clinical Efficacy and Safety Results from the READY-1 Phase III trial. Abstract presented at TOXINS 2024.
3.Ablon, G, et al. Treatment of Lateral Canthal Lines with RelabotulinumtoxinA, an Investigational Liquid Botulinum Toxin: Clinical Efficacy and Safety Results from the READY-2 Phase III Trial. Abstract presented at TOXINS 2024.
4.ClinicalTrials.Gov. Treatment of Moderate to Severe Glabellar Lines (READY-1). Available online: https://clinicaltrials.gov/study/NCT04249583. Last accessed January 2024.
5.ClinicalTrials.Gov. Treatment of Moderate to Severe Lateral Canthal Lines (READY-2). Available online: https://clinicaltrials.gov/study/NCT04249687. Last accessed January 2024.
6.ClinicalTrials.Gov. Treatment of Moderate to Severe Lateral Canthal Lines and Glabellar Lines Alone or in Combination (READY-3). Available online: https://clinicaltrials.gov/study/NCT04247074. Last Accessed January 2024.
7.ClinicalTrials.Gov. Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines (READY-4). Available online: https://clinicaltrials.gov/study/NCT04225260. Last accessed January 2024.
8.Sculptra. Instructions for Use. Galderma Laboratories. 2023.
9.Data on file. 43USSA1812EXT clinical study report. Fort Worth, TX: Galderma Laborato-ries, L.P. 2022.
10.Goldberg, D, et al. Single-arm study for the characterization of human tissue response to injectable poly-L-lactic acid. EDermatol Surg. 2013;39(6):915-922. doi: 10.1111/dsu.12164.
11.Fitzgerald, R, et al. Physiochemical Characteristics of Poly-L-Lactic Acid (PLLA). Aesthet Surg J. 2018;38(suppl_1):S13-S17. doi: 10.1093/asj/sjy012.
12.Bohnert K. et al. Randomized, Controlled, Multicentered, Double-Blind Investigation of Injectable Poly-L-Lactic Acid for Improving Skin Quality Dermatol Surg. 2019;45:718–724. doi: 10.1097/DSS.0000000000001772.
13.Durairaj, K, et al. A multi-center, retrospective, chart review to evaluate the safety of poly-L-lactic acid injectable implant when used in non-facial areas. Abstract presented at IMCAS 2024.
14.Humphrey, S, et al. Safety and Effectiveness of Poly-L-lactic acid (PLLA-SCA) for the Improvement in Appearance of Cellulite – A Pilot Study. Abstract presented at IMCAS 2024.
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Contacts
For further information:
Christian Marcoux, M.Sc.
Chief Communications Officer
christian.marcoux@galderma.com
+41 76 315 26 50
Sébastien Cros
Corporate Communications Director
sebastien.cros@galderma.com
+41 79 529 59 85
Emil Ivanov
Head of Strategy, Investor Relations, and ESG
emil.ivanov@galderma.com
+41 21 642 78 12
Jessica Cohen
Investor Relations and Strategy Director
jessica.cohen@galderma.com
+41 21 642 76 43
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