Galderma Receives European Union Approval for Restylane ® Shaype™: the First-and-Only Bone-Mimicking Hyaluronic Acid Injectable for Facial Shaping

Galderma (SIX: GALD) today announced that Restylane Shaype has been approved in the EU under the Medical Device Regulation for temporary augmentation of the chin region. Engineered for deep injection to build and shape on bone, Restylane Shaype delivers a unique bone-mimicking effect, enabling immediate, natural-looking structural enhancement in the lower face without surgery.^1-3

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The lower face plays a pivotal role in overall facial balance, influencing proportions and profile.² This region is an increasing area of concern for patients, with around one in four people expressing concerns related to lower face sagging and chin shape.⁵ When asked about their facial priorities, a third of people pointed out issues with their chin shape – a key contributor to facial definition and structural harmony.⁵ Genetic factors and age-related changes can lead to reduced chin definition and poor projection.^2,6 Until now, achieving structure in this area has largely relied on surgical implants, with no minimally invasive injectable aesthetic alternatives available for patients.²

Powered by Galderma’s new NASHA HD™ technology, Restylane Shaype is the firmest HA injectable gel available among market leaders in the facial filler market, with the highest G’ (measure of firmness) of the Restylane range.^2,3 As the first-and-only HA dermal filler specifically designed to allow aesthetic injectors to build and shape on the lower angles of the face, it provides greater projection with lower injection volumes.^2,7,8 Underpinning the Restylane range is a minimally modified HA gel that closely resembles naturally occurring HA, requires less product than other HA gels, and can be readily reversed, offering both performance and reassurance.^2,9-13

“Hyaluronic acid fillers remain the irreplaceable hero at the center of modern aesthetic care, yet the ability to achieve structural support in the face without surgery has long been limited. In my clinical practice, I have seen how Restylane Shaype can address this gap, supported by pivotal data demonstrating durable improvements in lower face structure and definition through 12 months, high patient satisfaction and strong willingness to repeat treatment. These findings mirror what I have been seeing in practice and highlight the value of a bone-mimicking HA injectable that enables predictable, natural-looking results aligned with individual patient anatomy and treatment goals.” DR. ANDREI METELITSA, MD, FRCPC, DABD, COSMETIC DERMATOLOGIST RESTYLANE SHAYPE PIVOTAL STUDY INVESTIGATOR CANADA

In a pivotal 12-month study, 83% of people treated with Restylane Shaype showed improved structure and definition at three months (66% at 12 months), and 84% of patients would agree to be treated with Restylane Shaype again.² Furthermore, up to 97% of patients would recommend treatment with Restylane Shaype to a friend.² Restylane Shaype injections are administered with a new, next-generation syringe to enhance precision and control through its ergonomic design and optimized syringe-needle connection.^1,14

To support consistent, individualized use of Restylane Shaype in clinical practice, Galderma has developed the Shayping Technique™.¹⁵ The technique combines Galderma’s Assessment, Anatomy, Range, and Treatment (AART™) methodology and the Facial Assessment Scale (FAS), enabling healthcare professionals to systematically evaluate lower face anatomy and facial balance, helping to identify individual patient priorities and treatment goals.^15,16 This assessment-led approach supports a broader understanding of lower face structure and is aligned with ongoing investigations of Restylane Shaype in areas such as the jawline.^15,16

“The EU approval of Restylane Shaype represents an important regulatory milestone for Galderma and for injectable aesthetics more broadly. With approvals now spanning Europe, Canada, and Brazil, this first-and-only HA shaper is a valuable new addition to the overall aesthetic landscape, and to the Restylane portfolio, expanding clinicians’ ability to address structural concerns in ways that traditional HA fillers are not designed to. It reflects the strength of our clinical development capabilities and our commitment to delivering innovative, science-based solutions that respond to the increasing global demand for facial balancing.” BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D. GLOBAL HEAD OF R&D GALDERMA

The distinctive bone-mimicking effect of Restylane Shaype reinforces how the Restylane HA treatment range is well-placed to address evolving aesthetic needs across all life stages, including aesthetic changes associated with medication-driven weight loss and menopause, which can affect bone density, structural support, and skin health. ^2,8,17-19

With over 30 years of innovation and more than 77 million treatments administered worldwide, the Restylane portfolio offers a versatile range of HA gels that remain highly relevant in responding to today’s most significant aesthetic trends and needs.^4,20,21 As patient expectations shift toward more effortless, always-on rejuvenation, Galderma’s ‘Wake Up To Restylane’ campaign positions Restylane as an everyday natural beauty ally for the face and other areas of the body, highlighting Galderma’s commitment to meeting emerging needs. Focused on the growing desire for natural, authentic results, the campaign underscores Restylane’s ability to deliver personalized outcomes that go beyond volumizing, helping people feel confident in their skin. ^2,22,23

About the Restylane portfolio

Restylane HA treatments are designed differently to go beyond volumizing for natural-looking results.^1,4,23 Our HA is minimally modified and our innovative manufacturing process preserves its biocompatibility while creating individual products designed for a specific purpose.^24-26 Powered by NASHA^®, NASHA HD™, OBT™ and SB-NASHA™ technologies, Restylane offers gels with the highest firmness to the highest flexibility, enabling personalized treatments that deliver structural support, natural-looking results, and a healthy glow.^2,3,27,28 Trusted for almost three decades, our HA gels work in sync with your skin for 100% natural-looking results.^4,29,30 Approved indications vary by market.

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. Restylane^® EU Instructions for Use. July 2026.
2. Nikolis A, et al. Effectiveness and Safety of a New Hyaluronic Acid Injectable for Augmentation and Correction of Chin Retrusion. J Drugs Dermatol. 2024;23(4):255–261. doi: 10.36849/JDD.8145.
3. Galderma. Data on file. MA-56724. 2023. Global rheology data (xStrain and G´ including Restylane SHAYPE).
4. Di Gregorio C, et al. 25+ years of experience with the Restylane portfolio of injectable HA fillers for facial aesthetic treatment. E-poster presented at AMWC; March 27-29, 2024; Monaco.
5. Galderma. Data on file. 2023. Restylane Shaype Consumer Study; Canada.
6. Cole JB, et al. Human facial shape and size heritability and genetic correlations. Genetics. 2017; 205(2): 967-978. doi: 10.1534/genetics.116.193185.
7. Nikolis A et al. Poster presentation: Effectiveness and Safety of a New NASHA-HD Hyaluronic Acid Injectable, HASHA, for Augmentation and Correction of Chin Retrusion. Presented at: IMCAS, 2024,Paris, France.
8. Galderma. Data on file. MA-56848. 2023. Technical data for Restylane SHAYPE.
9. Hilton S, et al. Randomized, evaluator-blinded study comparing safety and effect of two hyaluronic acid gels for lips enhancement. Dermatol Surg. 2018;44(2):261–269. doi: 10.1097/DSS.0000000000001282
10. Nikolis A, et al. The CHEEKY study: effectiveness of cheek treatment with hyaluronic acid fillers HA_VOL and HA_LYF. Poster presented at: AMWC, Monaco. 2022
11. Andriopoulos B, et al. Facial augmentation with hyaluronic acid fillers in an Asian population. Poster presented at AMWC, Monaco. 2019.
12. Jones D, et al. A randomized, comparator-controlled study of HA_RC for cheek augmentation and correction of midface contour deficiencies J Drugs Dermatol. 2021;20;949–956. doi:10 .36849 /JDD .6191
13. Weiss R, et al. a randomized, controlled, evaluator-blinded, multi-center study of hyaluronic acid filler effectiveness and safety in lip fullness augmentation. Dermatol Surg. 2021;47(4):527–532. doi: 10.1097/DSS.0000000000002856
14. Galderma. Data on file. Dekra Restylane next generation syringe report.
15. Nikolis A, et al. The ARTIST post-marketing study: Evaluating a high G’ hyaluronic acid injectable for chin treatment in combination with other hyaluronic acid fillers for lower face and midface treatment. E-poster presented at AMWC; October 21-23, 2025; Dubai.
16. Galderma. Data on file. AART Methodology Comprehensive Training Deck 2022.
17. Kapoor KM, et al. Treating aging changes of facial anatomical layers with hyaluronic acid fillers. Clin Cosmet Investig Dermatol. 2021;14:1105-1118. doi: 10.2147/CCID.S294812.
18. Fabi S, et al. The potential role of biostimulators/dermal fillers to address menopause related skin conditions. E-poster presented at IMCAS; October 21-23,2025; Dubai.
19. Nikolis A, et al. Consensus Statements on Managing Aesthetic Needs in Prescription Medication-Driven Weight Loss Patients: An International, Multidisciplinary Delphi Study. JCD. 2025;24: e70094. doi: 10.1111/jocd.70094.
20. Galderma. Data on file. MA-57232 [Updated]. 77 Million treated.
21. Galderma. Data on file. MA-55607. Restylane® 27 years data publications analysis
22. Galderma. Data on file. Global report: Aesthetics treatments and hyaluronic acid injectables. Consumers & HCPs. 2025.
23. Galderma. Data on file. MA-48544 Subject satisfaction (GAIS) – NASHA and OBT Fillers. 2021.
24. Edsman K, et al. Gel properties of hyaluronic acid dermal fillers. Dermatol Surg. 2012;38:1170–1179. doi: 10.1111/j.1524-4725.2012.02472.x.
25. Galderma. Data on file. MA-58650. Degree of modification of HA fillers.
26. Kablik J, et al. Comparative physical properties of HA dermal fillers. Dermatol Surg. 2009; 35, 302–312. doi: 10.1111/j.1524-4725.2008.01046.x.
27. Öhrlund Å et al. Differentiation of NASHA and OBT Hyaluronic Acid Gels According to Strength, Flexibility, and Associated Clinical Significance J Drugs Dermatol. 2024;23(1):1332–1336. doi: 10.36849/JDD.7648.
28. Belmontesi M et al. Injectable Non-Animal Stabilized Hyaluronic Acid as a Skin Quality Booster: An Expert Panel Consensus. J Drugs Dermatol. 2018;17(1):83–88.
29. Solish N, et al. Dynamics of HA fillers formulated to maintain natural facial expression. J Cosmet Dermatol. 2019;18(3):738-746. doi: 10.1111/jocd.12961.
30. Philipp‐Dormston WG, et al. Perceived naturalness of facial expression after HA filler injection in nasolabial folds and lower face. J Cosmet Dermatol. 2020;19(7):1600-1606. doi: 10.1111/jocd.1320

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