AMWC 2024: Galderma to Share New Data From Its Leading Injectable Aesthetic Portfolio

• Galderma’s diverse portfolio and educational efforts will be highlighted in 16 posters, and two sponsored symposia, exploring insights from the ground-breaking ‘NEXT by Galderma’ future aesthetic trends report and the use of Sculptra® for the body, as we celebrate its 25th anniversary
• Galderma will present pivotal clinical data on Restylane® SHAYPE™, the latest innovation complementing the Restylane portfolio, powered by the next generation of hyaluronic acid technology, NASHA HD™, which supports its safe and effective use for augmentation and correction of chin retrusion1
• Results showing high patient-reported satisfaction and improved wellbeing through six months after treatment with RelabotulinumtoxinA, an investigational highly-active, innovative, complex-free, and ready-to-use liquid neuromodulator, will also be presented2,3

ZUG, Switzerland -- (BUSINESS WIRE) --

Galderma will present the latest updates from its broad portfolio of clinically-proven and holistic range of aesthetic treatments at the 22nd Aesthetic & Anti-Aging Medicine World Congress (AMWC) on March 27-29, 2024. The diversity of Galderma’s portfolio, designed to meet the individual needs of healthcare professionals and patients, will be showcased in 16 research posters – including data from the world’s most diverse range of fillers (Restylane®), leading neuromodulator portfolio (RelabotulinumtoxinA, Alluzience® and Azzalure®) and original biostimulator (Sculptra®) – as well as two symposia and a booth, which will host an array of live demonstrations and ‘Meet the Expert’ sessions.

“Galderma’s extensive activities at AMWC demonstrate our commitment to pushing the boundaries of injectable aesthetics, to anticipate and address tomorrow’s needs today. By evolving and expanding our existing treatments, developing new innovations, and conducting cutting-edge research into the groundbreaking trends that are anticipated to drive the future of aesthetics, our future-facing approach ensures we continue to deliver the best for healthcare professionals and patients.”   BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D. GLOBAL HEAD OF R&D GALDERMA

Educating on the future of aesthetics and Sculptra’s expanding indications

The Galderma-sponsored symposium, The AART™ and Science behind NEXT, will host a panel of world-renowned aesthetic experts, including Dr. Sebastian Cotofana, Dr. Alessandra Haddad, Dr. Christoph Martschin, Dr. Andreas Nikolis, Dr. Sachin Shridharani, and Dr. Van Park, who will delve into the six identified groundbreaking trends that are anticipated to drive the future of aesthetics and how they will impact consultation and interaction with patients. A live demonstration will show how to best integrate the trends’ insights in practice via Galderma’s holistic assessment tool, the AART methodology, and create bespoke treatment plans for patients. The event is taking place in Room Prince Pierre on Wednesday March 27, 2024, from 2:00 to 4:00 PM CET.

As we celebrate 25 years of science and expertise in biostimulation with Sculptra, Galderma’s second symposium, The AART™ of Sculptra beyond the face, will focus on how to use the AART assessment tool to address patients’ body concerns and needs. Prominent experts in the field, including Dr. Luiz Avelar, Dr. Sebastian Cotofana, Dr. Alessandra Haddad, and Dr. Marcus Morais, will focus on how to assess and treat the gluteal (buttock) region to address different patient profiles with Sculptra treatment. Through clinical cases, they will also touch on Sculptra’s use on the décolletage, neck and upper arms. The event is taking place in Room Van Dongen on Thursday March 28, 2024, from 11:00 to 11:55 AM CET.

Extensive data spotlight how Galderma is advancing dermatology for every skin story

Pivotal clinical data supporting the safe and effective use of Restylane SHAYPE™ for augmentation and correction of chin retrusion, with clinical results sustained for up to 12 months, will be presented.1 Restylane SHAYPE is the latest innovation in hyaluronic acid (HA) injectables, powered by new NASHA HD™ technology, the next generation in HA science. Restylane SHAYPE is engineered to shape angles in the lower face by providing a bone mimicking effect.1 It is the newest addition to the Restylane portfolio, the world’s most diverse range of fillers with over 27 years of clinical data, which encompasses different technologies (NASHA®, OBT™ and now NASHA HD) and gel characteristics, with solutions available to meet the needs of patients and injectors all over the world.4 Additional data from studies of Restylane VOLYME™ and EYELIGHT™ will be shared for midface augmentation and correction of infraorbital hollows (dark under-eye shadows and grooves), respectively, with improvements maintained through to 12 months.5,6

New data from the phase III READY-1 and READY-2 studies will also be presented, showing high patient-reported satisfaction and improved wellbeing through six months after treatment with RelabotulinumtoxinA for glabellar lines (frown lines) and lateral canthal lines (crow’s feet).2,3 The treatment was well tolerated and improvement in frown line and crow’s feet severity and aesthetic appearance was maintained through six months.2,3 Developed using Galderma’s proprietary PEARLTM technology, RelabotulinumtoxinA is a highly-active, ready-to-use solution that delivers fast and sustained results and maximizes ease-of-use to address the real needs of patients and healthcare professionals.7-19

Six posters on Sculptra, the first and original biostimulator, with a unique PLLA-SCA™ formulation that activates the body's natural power to revitalize key components of the skin for a more youthful appearance, will be presented at AMWC. Additional data spanning our leading neuromodulator portfolio, Alluzience and Azzalure, will be presented, as well as a new skin quality assessment scale and the AART-HIT™ approach for combining aesthetic products to maximize patient outcomes.

More details on scientific presentations supported by Galderma at AMWC can be found here.*

*All presenters are paid consultants or employees of Galderma.

About the Restylane® Portfolio

With more than 27 years of experience, over 160 clinical publications, and trusted with 65 million treatments and growing worldwide, the Restylane portfolio’s three complementary gel technologies – NASHA®, OBT™ and NASHA HD™ – allow for individualized, natural-looking results and long-term patient satisfaction.4,20,21 The uniqueness and complementary nature of the Restylane portfolio allows for individualized, natural-looking results, providing long-lasting improvement and long-term satisfaction for patients’ self-confidence.4,20-23

About RelabotulinumtoxinA (QM1114)

Developed by Galderma, RelabotulinumtoxinA is a highly-active, innovative, complex-free, and ready-to-use liquid neuromodulator 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. RelabotulinumtoxinA is an investigational product and has not received approval for any indication in any country.

About Sculptra®

Sculptra is the original biostimulator and is clinically proven to stimulate the skin's innate collagen (type I) production to increase skin firmness and radiance, for long-lasting, natural-looking rejuvenated appearance. Sculptra is proven to increase collagen type I by 66.5% after three months through a process that starts stimulation as early as five days after injection.24 It helps progressively restore the skin’s foundation and natural structural function. Sculptra is proven to achieve natural-looking results that last for more than two years.25 Sculptra provides targeted collagen stimulation, with unique treatment protocols developed for each treatment area and to achieve the patients’ desired results.

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. Nikolis, A, et al. Effectiveness and Safety of a New NASHA-HD Hyaluronic Acid Injectable, HASHA, for Augmentation and Correction of Chin Retrusion. E-poster presented at AMWC 2024

2. Gold, M, et al. Subject-Reported Improvement in Well-Being and High Satisfaction After Glabellar Line Treatment with RelabotulinumtoxinA, an Investigational ready-to-Use Liquid Botulinum Toxin (READY-1 Phase III Trial). E-poster presented at AMWC 2024

3. Grunebaum, L, et al. Improved Well-Being and Natural-Looking Results After Treatment of Lateral Canthal Lines with RelabotulinumtoxinA, an Investigational Liquid Botulinum Toxin (READY-2 Phase III Trial). E-poster presented at AMWC 2024

4. Carlo Di Gregorio. 25+ Years of Experience with the Restylane Portfolio of Injectable Hyaluronic Acid Fillers for Facial Aesthetic Treatment. E-poster presented at AMWC 2024

5. Ren, R, et al. Midface Augmentation in Chinese Subjects Using a Flexible Hyaluronic Acid Filler Evaluated in a Randomized No-treatment Controlled Study. E-poster presented at AMWC 2024

6. Biesman, B, et al. A Study Evaluating the Safety and Effectiveness of Hyaluronic Acid Filler HAEYE for Correction of Infraorbital Hollows (IOH, Tear Trough Study). E-poster presented at AMWC 2024

7. Galderma. Data on file. Clinical Study Report for Protocol 43QM1602: READY-1. Galderma Laboratories; 2021

8. Galderma. Data on file. Clinical Study Report for Protocol 43QM1901: READY-2. Galderma Laboratories; 2021

9. Galderma. Data on file. READY-2 Post-hoc Tables. Galderma Laboratories; 2021

10. Galderma. Data on file. Clinical Study Report for Protocol 43QM1902: READY-3. Galderma Laboratories; 2021

11. Galderma. Data on file. Clinical Study Report for Protocol 43AM1903: READY-4. Galderma Laboratories; 2021

12. Galderma. Data on file: Initial results of the phase IIIb 43QM2106 trial; 2023

13. Galderma. Data on file: Initial results of the phase IIIb 43QM2107 trial; 2023

14. 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

15. 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

16. Bertucci, V, et al. Efficacy and Safety of a Novel Formulation Liquid Botulinum Toxin, RelabotulinumtoxinA, when used for Combination Treatment of Glabellar and Lateral Canthal Lines. Abstract presented at TOXINS 2024

17. Persson, C, et al. Patient and Investigator Treatment Experience with Ready-to-Use AbobotulinumtoxinA Solution Versus Powder BotulinumtoxinA for Treatment of Glabellar Lines. Abstract presented at TOXINS 2024

18. Sundberg, AL, and Stahl, U. Relabotulinum toxin - a novel, high purity BoNT-A1 in liquid formulation. Presented at: TOXINS 2021

19. Do, M, et al. Purification process of a complex-free highly purified botulinum neurotoxin type A1 (BoNT-A1) - relabotulinumtoxinA. Presented at: TOXINS 2022

20. Nikolis, A, et al. The Role of Clinical Examination in Midface Volume Correction Using Hyaluronic Acid Fillers: Should Patients Be Stratified by Skin Thickness? Aesthet Surg J Open Forum. 2020; 2(1):1–12.

21. Galderma. Data on file. Subject satisfaction (GAIS) – NASHA and OBT Fillers. 2021

22. Narins, RS, et al. Persistence of nasolabial fold correction with a hyaluronic acid dermal filler with retreatment: results of an 18-month extension study. Dermatol Surg. 2011;37:644–650

23. Talarico, S, et al. High Patient Satisfaction of a Hyaluronic Acid Filler Producing Enduring Full-Facial Volume Restoration: An 18-Month Open Multicenter Study. Dermatol Surg. 2015;41:1361–1369

24. Goldberg, D, Guana, A, Volk, A, Daro-Kaftan, E. Single-arm study for the characterization of human tissue response to injectable poly-L-lactic acid. Dermatol Surg. 2013;39(6):915-922

25. Fabi, S, et al. 24-month clinical trial data on effectiveness and safety after correction of cheek wrinkles using a biostimulatory poly-L-lactic acid injectable implant. Poster presented at AMWC 2023