Celebrating 25 Years of Sculptra ® : New Data and Recent Approval in China Cements Galderma’s Leadership in Regenerative Biostimulation

This monthmarks the 25^th anniversary of the approval of Sculptra^®, the first proven regenerative biostimulator with a unique poly-L-lactic acid (PLLA-SCA™) formulation.^1-5,10-16 Sculptra works with the body’s natural processes to achieve healthier, radiant skin and a more youthful appearance, and has been a cornerstone of Galderma’s broad portfolio of proven aesthetic treatments.^17,18 During its 25 years on the market, healthcare professionals have treated millions of patients with Sculptra, with distribution in over 40 countries and regions worldwide.^10,12,19,20

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Pioneer in regenerative aesthetics: Working with the natural processes of the skin

Regenerative aesthetics is an emerging and fast-growing trend in the field.^21,22 It focuses on revitalizing the skin by engaging the body’s own healing mechanisms, working across three layers of the skin to restore and rejuvenate from within and address patient concerns such as volume loss, skin laxity, and structural support loss.^{1,13,18,23-26}

Recent gene expression data from a head-to-head study presented at the American Society for Dermatologic Surgery (ASDS) 2024 Annual Meeting showed that Sculptra stimulated more components of the extracellular matrix, including collagen and elastin, while inducing less inflammation, when compared with another biostimulator.⁶ Sculptra stimulated 16 pathways related to tissue remodeling and four related to collagen formation, compared to 10 and three, respectively, for the comparator biostimulator.⁶

Additional data presented at the ASDS 2024 Annual Meeting demonstrate Sculptra’s potential positive effect on adipocyte modulation, which might explain its clinical benefits in skin quality such as increased skin glow, improved facial fat function and structure, and reduced signs of facial aging.⁷ The data showed that treatment with Sculptra resulted in upregulation of 13 genes associated with anti-inflammatory effects and adipocyte modulation.⁷

This was reinforced by two new studies published this year in the Journal of Drugs in Dermatology, which provided supportive as well as deeper insights into the regenerative effects of Sculptra.^5,8 This includes results showing that Sculptra significantly reduced the severity of moderate or severe cheek wrinkles while improving skin quality, with results lasting across the 12-month study period.⁸ The responder rate was significantly higher for Sculptra versus the no-treatment control at seven months (66.2% and 38.6%), nine months (70.6% and 31.1%) and 12 months (71.6% and 26.1%).⁸ Sculptra maintained high patient satisfaction, with over 84% of patients reporting natural-looking results and expressing interest in repeat treatments to correct cheek wrinkles.⁸

Sculptra’s PLLA-SCA™ formulation ensures comprehensive results that improve the skin’s underlying structure, as well as surface appearance.^1,13,23-25 By remodeling components of the extracellular matrix, such as elastin and collagen, Sculptra can restore youthful volume through its regenerative properties.^2,6,7,27-28

“Sculptra has fundamentally changed the landscape of facial rejuvenation and has had a significant impact on my practice. Sculptra helps to restore patients’ youthful appearance and improve skin quality, while looking and feeling natural – and my patients' satisfaction is evident in their continued attendance at yearly maintenance sessions. This, coupled with the extensive body of evidence on Sculptra’s efficacy and safety, positions Sculptra as a leading choice for practitioners.” ALESSANDRA HADDAD, M.D., PH.D. AFFILIATE PROFESSOR FEDERAL UNIVERSITY OF SAO PAULO BRAZIL

Celebrating 25 years of scientific progress with Sculptra

Sculptra was first launched and approved in the European Union as a volume replenishment treatment in 1999 to correct the facial wasting experienced by AIDS patients.²⁸ A transformative treatment, Sculptra helped reverse the gaunt appearance associated with this disease by stimulating the skin’s natural collagen and elastin production, restoring facial vitality and youthful volume.^6,7,28,29

Over the years, through Galderma’s continued research into Sculptra’s unique scientific dermatological potential with PLLA-SCA™, it has evolved into a versatile treatment with a range of applications beyond volumization, which can include skin firmness, structural support, radiance, and overall skin quality, with results lasting for over two years.^2,17,29,30

Recent research shows that, in addition to collagen, Sculptra’s PLLA-SCA™ formulation also has a stimulatory effect on key components of the extracellular matrix, such as elastin, proteoglycans and multi-adhesive glycoproteins, and agents which activate the remodeling of adipose (fat) tissue, making it the first proven regenerative biostimulator.^1-7,24,28 These properties open exciting new possibilities to meet emerging patient needs, such as addressing facial alterations associated with significant or rapid weight loss.²⁹

“Sculptra is testament to our commitment to innovation. With over 50 publications and 10,000 patients in clinical studies to date, its safety profile and efficacy are unmatched. We’re excited that even after 25 years, we’re uncovering new information about Sculptra’s regenerative properties, allowing us to explore new possibilities to help patients have better outcomes in their quest for natural, long-lasting rejuvenation.” PROF. ALAN WIDGEROW, MBBCH; MMED; FCS; FACS CHIEF SCIENTIFIC OFFICER, HEAD OF SKIN SCIENCE CENTER FOR INNOVATION, HEAD OF ALASTIN INNOVATION GALDERMA

Sculptra is approved by multiple regulatory authorities, most recently in China – one of the fastest-growing markets in aesthetics and a key growth driver for Galderma.^9,31,32 This approval further expands Sculptra's global reach and accessibility and underscores its ability to meet diverse patient needs and beauty standards across different regions.

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.^{1-5,10-16,23-25} 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.^1,13,23-25 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.^6,7,27,28 The results from Sculptra are long-lasting, with optimal correction seen in approximately three months and results lasting up to two years.^2,17,24,33

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. Sculptra^®. EU Instructions for Use. 2021. Available online. Accessed October 2024
2. 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
3. Galderma. Data on File (MA-60875)
4. Zhang Y, et al. In vivo inducing collagen regeneration of biodegradable polymer microspheres. Regen Biomater. 2021;8(5):rbab042. doi: 10.1093/rb/rbab042
5. 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
6. 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
7. 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, Floria, United States
8. Fabi S, et al. Effectiveness and Safety of Sculptra PLLA Inj. Implant in the correction of Cheek Wrinkles. J Drugs Dermatol. 2024;23(1):1297-1305. doi: 10.36849/JDD.7729
9. Galderma. Galderma Q3 earnings media release. Available online. Accessed October 2024
10. U.S. Food and Drug Administration. Summary of safety and effectiveness data. Available online. Accessed October 2024
11. Galderma. Data on File (MA-46589)
12. 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
13. Zhang S and Duan E. Fighting against Skin Aging: The Way from Bench to Bedside. Cell Transplant. 2018;27(5):729-738. doi: 10.1177/0963689717725755
14. Asius J, et al. Inventors. US patent US 7,731,758 B2.2010. Available online. Accessed October 2024
15. 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
16. Galderma. Data on File (MA-53568)
17. 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
18. Fabi S, 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. Poster presented at IMCAS World Congress, January 26–28, 2023, Paris, France
19. Galderma. Galderma Continues Global Growth Ambition With Sculptra^® (injectable poly-L-lactic acid) Re-launch in Europe. Available online. Accessed October 2024
20. Galderma. Data on File (MA-54105)
21. Trovato F, et al. Advancements in Regenerative Medicine for Aesthetic Dermatology: A Comprehensive Review and Future Trends. Cosmetics. 2024;11(2):49. doi:10.3390/cosmetics11020049
22. Hamilton Fraser. Emerging aesthetic trends and technologies in 2024. Available online. Accessed October 2024
23. 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
24. 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
25. 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
26. Galderma. Data on file
27. 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
28. 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
29. Avelar LE and Haddad A. Facial assessment for poly-l-lactic acid application—One product, different outcomes. J of Derm & Cos. 2023;7,3. doi: 10.15406/jdc.2023.07.00239
30. Snyder A, et al. Sculptra^®—History and how it is best used today. Derm Reviews. 2023;4(3). doi: 10.1002/der2.186
31. Kwon SH, et al. Experiences and attitudes toward aesthetic procedures in East Asia: a cross-sectional survey of five geographical regions. Arch Plast Surg. 2021;48(6):660-669. doi: 10.5999/aps.2020.02565
32. Asia Pacific Medical Aesthetics Market Size, Share & Industry Trends Analysis Report By End User (Clinics, Hospitals, & Medicals Spas, Beauty Centres, & Home Care Settings), By Procedure, By Product, By Country and Growth Forecast, 2023 – 2030. Available online. Last accessed October 2024
33. 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

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