• Galderma will present new data on Relfydess (RelabotulinumtoxinA) – the first and only ready-to-use liquid neuromodulator created using PEARL™ Technology, which has now launched in multiple countries in Europe – including results from the phase IIIb RELAX trial, reinforcing its long-term efficacy and high patient satisfaction, as seen in the READY clinical trial program1-7
• New data on Sculptra®, the first proven regenerative biostimulator, emphasize its regenerative properties and effect across all three skin layers, including in comparison to other biostimulators8-12
• Recent data from the Restylane portfolio highlight its ability to preserve naturalness of facial expressions and reveal that the new hyaluronic acid (HA)-injectable Restylane SHAYPE, powered by Galderma’s innovative NASHA HD™ Technology, has the highest G-prime among commonly used HA-fillers13,14
• These data, combined with three symposia, a Masterclass on addressing the aesthetic impact of medication-driven weight loss on the skin, and several Meet the Expert sessions, once again showcase and differentiate Galderma’s broad and clinically proven portfolio, setting it apart as the pure-play category leader in dermatology

ZUG, Switzerland -- (BUSINESS WIRE) --

Galderma will present the latest updates from its innovative aesthetics portfolio at the International Master Course on Aging Science (IMCAS) World Congress 2025 on January 30 – February 1 in Paris, France. The company will share ten research e-posters with data that differentiate its injectable aesthetic products, including Relfydess (RelabotulinumtoxinA), Sculptra and Restylane. Alongside its community partners, Galderma will also host three symposia, a Masterclass, five Meet the Expert sessions, and an interactive booth focused on the power of Relfydess.

“With such an extensive presence at the IMCAS congress this year, we have another opportunity not only to share the latest advancements from our broad and innovative injectable aesthetics portfolio, but also to connect with the community in a meaningful way, through information sharing and insights gathering. Our offering at IMCAS brings our Integrated Dermatology Strategy to life, differentiates our products, and cements Galderma as the category leader in dermatology.”

BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D.
GLOBAL HEAD OF R&D
GALDERMA

Extensive data updates from across the industry’s broadest Injectable Aesthetics portfolio

New data will include results from the phase IIIb RELAX study investigating the long-term aesthetic improvement and subject satisfaction over 12 months following a single dose of Relfydess in patients with moderate-to-severe frown lines.15 This study reinforces previously announced data from the READY clinical trial program, demonstrating that up to 39% of patients see effects from day one and up to 75% of patients maintain improvements for six months for frown lines and crow’s feet when treated with Relfydess.3,4,7

Additional findings will further reinforce the scientific differentiation of Relfydess, including data adding to the effect of Galderma’s proprietary PEARL Technology process on preserving molecule integrity, and showing no neutralizing antibody formation across Relfydess’ phase III program.16,17 A pooled post-hoc analysis from the READY-1-3 trials will also be presented, affirming the efficacy of Relfydess across more than 1,700 patients with diverse skin types, ethnicities, and races.18

In addition, a symposium titled ‘Go beyond with Relfydess: Step into the future’ will take place on Friday, January 31, from 2:00 – 3:30 PM CET, in Grand Amphi, and will showcase the clinical performance and innovative volumetric approach of Relfydess, featuring a live injection demonstration. At the Galderma booth – #L212 – experts will also dig deeper into the cutting-edge science behind Relfydess and PEARL Technology.

Galderma will also present the latest data on Sculptra, the first proven regenerative biostimulator with a unique poly-L-lactic acid (PLLA-SCA™) formulation.8-12 New data reinforce its robust regenerative properties and effects across all three skin layers, underscoring its key role in the regenerative aesthetics field, including its benefit in comparison to other products.19-21 Studies suggested Sculptra stimulated the key components of the skin, including collagen, elastin and adipose tissue, and reinforced its favorable safety profile.19-21 An additional comparative study found synergistic effects for the midface when pairing Sculptra with Alastin®, with an improvement in aging skin and patient experience when using both.22

New pooled data from three Galderma studies of the Restylane portfolio will be presented, demonstrating that treatments with Restylane Refyne™ and Restylane Defyne™ not only enhance attractiveness and youthfulness, but also preserve naturalness of both relaxed and dynamic facial expressions.23 Additionally, gel data for Restylane SHAYPE – the latest addition to the broadest hyaluronic acid (HA) portfolio, which is powered by Galderma’s innovative NASHA HD Technology with improved crosslinking efficiency and increased HA content – reveal it has the highest G-prime among commonly used HA fillers, indicating superior gel strength and firmness, making it ideal for lower face shaping.14

Connecting with the dermatology community

Beyond sharing the latest data, the IMCAS World Congress also represents an important opportunity to connect with the broader dermatology community in order to facilitate best practice sharing and gather crucial insights to guide future innovation. The Galderma Aesthetic Injector Network (GAIN) – which celebrates its 10th anniversary this year – is Galderma’s long-established training platform designed to educate, inspire, and empower through the creation of a unique community of highly trained, clinically proficient aesthetic practitioners. As part of this enduring commitment to the community, Galderma will host a symposium at the congress titled ‘GAIN Debates: Crafting Our Aesthetic Lives – Prioritization for Impactful Treatment’, taking place Friday, January 31, from 10:30 AM – 12:30 PM CET in Amphi Bleu. A separate medical symposium titled ‘Innovation by Galderma: Where Aesthetics Meets Science’ will also be held on Friday, January 31 from 9:00 – 10:00 AM CET in Regency 3+4 on Level 4.

Galderma will also run a Masterclass session on using injectables to address the specific aesthetic needs related to the effects of medication-driven weight loss, taking place on Thursday, January 30 from 2:00 – 4:00 PM CET in Salon d’honneur. Five Meet the Expert sessions will also further reinforce Galderma’s unique position as a leader in dermatology. The sessions will explore topics including Skin Quality, end-to-end collagen and elastin stimulation, and redefining HA fillers to create natural looking results, and will dig deeper into Alastin, Sculptra, and Relfydess as part of these discussions. The events will be held at the Galderma booth and live streamed on the @GAINbyGalderma Instagram profile.

More details on Galderma’s scientific presentations at IMCAS can be found here.

About Relfydess (RelabotulinumtoxinA)
Pioneered by Galderma, Relfydess is the first and only ready-to-use liquid neuromodulator created with PEARL Technology that is designed to preserve molecule integrity.1,2 PEARL Technology is designed to deliver a highly active, innovative, complex-free molecule, with up to 39% of patients seeing effects from day one and up to 75% of patients maintaining improvements for six months.1-4,7 Relfydess is optimized for simple volumetric dosing, without reconstitution, to increase ease-of-use and help ensure consistent dose/volume every time.1,24 It was entirely created and manufactured by Galderma to expand its neuromodulator portfolio as part of the broadest Injectable Aesthetics portfolio on the market.

About Sculptra
Sculptra is the first proven regenerative biostimulator, with a unique PLLA-SCA formulation that helps restore the deep, underlying structure of the skin.8-12,25-34 Sculptra works to address the underlying causes of facial aging, including degradation of the extracellular matrix, which results in volume loss, laxity, and the appearance of wrinkles.8,28,32-34 Sculptra encourages the remodeling of components of the extracellular matrix, such as elastin and collagen, helping to gradually restore facial volume and the look of fullness to wrinkles and folds over time.35-38 The results from Sculptra are long-lasting, with optimal correction seen in approximately three months and results lasting up to two years.9,33,39,40

About the Restylane Portfolio
Restylane hyaluronic acid (HA) injectables are Designed Differently to go beyond volumizing for natural-looking results.41-44 Our HA is exceptionally pure, making it the closest to the skin’s own.45 Our innovative manufacturing process preserves its biocompatibility while creating individual products designed for a specific purpose. Restylane unique technologies, NASHA HD, NASHA® and OBT™ are meaningfully designed to mimic the diverse range of facial structures and skin layers.41-43 With the Highest G’ and Highest flexibility, Restylane can provide from structural support to natural expression to a healthy glow.14,42,45-48 Trusted for almost three decades, our HA gels work in sync with your skin for 100% natural looking results.41,49,50

About Galderma
Galderma (SIX: GALD) is the 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 through 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. Sundberg AL and Stahl U. Relabotulinum toxin - a novel, high purity BoNT-A1 in liquid formulation. Presented at: TOXINS 2021; Jan 16-17, 2021; virtual meeting
2. Do M, et al. Purification process of a complex-free highly purified botulinum neurotoxin type A1 (BoNT-A1) - relabotulinumtoxinA. Presented at: TOXINS 2022; July 27-30, 2022; New Orleans, LA
3. Shridharani SM, et al. Efficacy and Safety of RelabotulinumtoxinA, a New Ready-to-Use Liquid Formulation Botulinum Toxin: Results From the READY-1 Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial in Glabellar Lines. ASJ. 2024; sjae131
4. Ablon G, et al. Efficacy and Safety of RelabotulinumtoxinA Liquid Botulinum Toxin in the Treatment of Lateral Canthal Lines: Results From the Phase 3 READY-2 Study. Dermatol Surg. 2024. doi: 10.1097/DSS.0000000000004470
5. Prather HB, et al. Efficacy and safety of a novel formulation liquid botulinum toxin, RelabotulinumtoxinA, when used for combination treatment of glabellar and lateral canthal lines. E-poster presented at: ASDS 2024; October 17-20, 2024; Orlando, Florida, United States
6. Beer K, et al. READY-4: Long-term safety with repeated injections using RelabotulinumtoxinA, a novel liquid formulation botulinum toxin, in the treatment of glabellar and lateral canthal lines. E-poster presented at: ASDS 2024; October 17-20, 2024; Orlando, Florida, United States
7. Relfydess®. EU Summary of Product Characteristics
8. Sculptra®. EU Instructions for Use. 2021. Available online. Accessed January 2025
9. Widgerow A, et al. A randomized, comparative study describing the gene signatures of Poly-L-Lactic Acid (PLLA-SCA) and Calcium Hydroxylapaptite (CaHA) in the treatment of nasolabial folds. Poster presented at IMCAS World Congress, February 1-3, 2024, Paris, France
10. Galderma. Data on File (MA-60875)
11. Zhang Y, et al. In vivo inducing collagen regeneration of biodegradable polymer microspheres. Regen Biomater. 2021;8(5): rbab042. doi: 10.1093/rb/rbab042
12. Huth S, et al. Molecular Insights into the effects of PLLA_SCA on Gene Expression. J Drugs Dermatol. 2024;23(4):285-288. doi: 10.36849/JDD.7791
13. Philipp-Dormston, W.G., Wong, C., Schuster, B., Larsson, M.K. and Podda, M., 2018. Evaluating perceived naturalness of facial expression after fillers to the nasolabial folds and lower face with standardized video and photography. Dermatologic Surgery, 44(6), pp.826-832.
14. Bromée T, et al. A new hyaluronic acid injectable, HASHA, sets new G-prime standards. Abstract presented at IMCAS World Congress, January 30 – February 1, 2025, Paris, France.
15. Moradi A, et al. Aesthetic improvement and subject satisfaction with liquid relabotulinumtoxinA treatment of glabellar lines in a 12-month, randomized, controlled trial. Abstract presented at IMCAS World Congress, January 30 – February 1, 2025, Paris, France
16. Lekholm E, et al. RelabotulinumtoxinA, a ready-to-use formulation neuromodulator manufactured with PEARL™ technology to maintain high potency and specific activity. Abstract presented at IMCAS World Congress, January 30 – February 1, 2025, Paris, France.
17. Nestor M, et al. RelabotulinumtoxinA did not induce the formation of neutralizing antibodies across almost 1700 subjects treated in the Phase III Program. Abstract presented at IMCAS World Congress, January 30 – February 1, 2025, Paris, France.
18. Bertucci V, et al. Treatment of Glabellar Lines and Lateral Canthal Lines with RelaBoNT-A Across Different Ethnicity and Race: Pooled Data from Three Phase III Studies. Abstract presented at IMCAS World Congress, January 30 – February 1, 2025, Paris, France.
19. Fabi S, et al. Regenerative aesthetic effects of poly L-lactic acid (Sculptra®) treatment. Abstract presented at IMCAS World Congress, January 30 – February 1, 2025, Paris, France.
20. Haddad A, et al. Comparing poly L-lactic acid (PLLA-SCA) and calcium hydroxylapatite (CaHA-R) in-vivo. Abstract presented at IMCAS World Congress, January 30 – February 1, 2025, Paris, France.
21. Avelar L, et al. Comparing two biostimulators on the local tissue response and degradation in-vivo with an indirect comparison to clinical outcomes. Abstract presented at IMCAS World Congress, January 30 – February 1, 2025, Paris, France.
22. Markowitz O, et al. Evaluation of synergistic effects for midface improvement when pairing Sculptra® (PLLA-SCA) with Alastin skincare®: A comparative study. Abstract presented at IMCAS World Congress, January 30 – February 1, 2025, Paris, France.
23. Nikolis A, et al. Hyaluronic acid fillers preserve natural movement and dynamic expression: data from three Phase IV clinical trials. Abstract presented at IMCAS World Congress, January 30 – February 1, 2025, Paris, France.
24. 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; Jan 17-20, 2024, Berlin
25. U.S. Food and Drug Administration. Sculptra summary of safety and effectiveness data. Available online. Accessed January 2025.
26. Galderma. Data on File (MA-46589)
27. Duracinsky M, et al. Safety of poly-L-lactic acid (New-Fill®) in the treatment of facial lipoatrophy: a large observational study among HIV-positive patients. BMC Infect Dis. 2014;14(474). doi:10.1186/1471233414474
28. Zhang S and Duan E. Fighting against Skin Aging: The Way from Bench to Bedside. Cell Transpl. 2018;27(5):729-738. doi: 10.1177/0963689717725755
29. Asius J, et al. Inventors. US patent US 7,731,758 B2.2010. Available online. Accessed January 2025
30. Morgan P, et al. Product Manufacturing Process for Poly-L-lactic acid (PLLA-SCA). Poster presented at IMCAS World Congress, January 26–28, 2023, Paris, France
31. Galderma. Data on File (MA-53568)
32. Shuster S, et al. The influence of age and sex on skin thickness, skin collagen and density. Br J Dermatol. 1975;93(6):639-43. doi: 10.1111/j.1365-2133.1975.tb05113.x
33. Goldberg D, et al. Single-arm study for the characterization of human tissue response to injectable poly-L-lactic acid. Dermatol Surg. 2013;39:915–22
34. Zarbafian M, et al. The emerging field of regenerative aesthetics—where we are now. Dermatol Surg. 2022;48: 101–108. doi: 10.1097/DSS.0000000000003239
35. Waibel J, et al. Gene Analysis of Biostimulators: PLLA-SCA Triggers Regenerative Morphogenesis while CaHA-R Induces Inflammation upon Facial Injection. Poster presented at ASDS 2024, October 17-20, 2024, Orlando, Florida, United States
36. Waibel J, et al. Bulk RNA-seq Analysis of Poly-L-Lactic Acid (PLLA-SCA) vs Calcium Hydroxyapetite (CaHA-R) Reveals a Novel, Adipocyte Mediated Regenerative Mechanism of Action Unique to PLLA. Poster presented at ASDS 2024 Annual Meeting, October 17-20, 2024, Orlando, Florida, United States
37. Haddad S, et al. Evaluation of the biostimulatory effects and the level of neocollagenesis of dermal fillers: a review. Int J Dermatol. 2022;61:1284–1288. doi: 10.1111/ijd.16229
38. Vleggaar D, et al. Consensus recommendations on the use of injectable poly-L-lactic-acid for facial and nonfacial volumization. J Drugs Dermatol. 2014;13(4 Suppl):s44–s51
39. Hexsel D, et al. Introducing the L-Lift-A Novel Approach to Treat Age-Related Facial Skin Ptosis Using A Collagen Stimulator. Dermatol Surg. 2020;46(8):1122–1124. doi:10.1097/DSS.0000000000002015
40. 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, March 30 - April 1, 2023, Monaco
41. Di Gregorio C. 25+ Years of Experience with the Restylane Portfolio of Injectable Hyaluronic Acid Fillers for Facial Aesthetic Treatment. E-poster presented at AMWC, March 27-29, 2024, Monaco
42. 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.
43. Galderma. Data on file. Subject satisfaction (GAIS) – NASHA and OBT Fillers. 2021
44. Restylane U.S. Instructions For Use. Available online. Accessed January 2025.
45. Kablik J, et al. Comparative Physical Properties of Hyaluronic Acid Dermal Fillers: Dermatologic Surgery 35, 302–312 (2009).
46. 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
47. 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
48. Ohrlund A, et al. Differentiation of NASHA and OBT Hyaluronic Acid Gels According to Strength, Flexibility, and Associated Clinical Significance. JDD. 2024; 23(1), pp.1332-1336.
49. Solish N, et al. Dynamics of hyaluronic acid fillers formulated to maintain natural facial expression. J Cosmet Dermatol. 2019;18(3):738-46.
50. Philipp‐Dormston WG, et al. Perceived naturalness of facial expression after hyaluronic acid filler injection in nasolabial folds and lower face. J Cosmet Dermatol. 2020;19(7):1600-6.