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Mexico Becomes the First Market Worldwide to Receive Approval for Galderma's Restylane® Shaype(TM) for Both Chin and Its First Jawline Indication

Galderma

  • Restylane Shaype is now approved in Mexico for temporary augmentation in the chin area and improvement of jawline definition,1 with launch anticipated in H1 2027
  • Already approved across various markets globally for the chin area,2 this marks Restylane Shaype’s first approval for the jawline worldwide1
  • The first-and-only shaper on the hyaluronic acid (HA) market, Restylane Shaype features the firmest HA gel available and is powered by proprietary NASHA HD™ technology, developed to build and shape on bone for instant, natural-looking contour and definition3-6
  • The approval reinforces Galderma's commitment to advancing innovation in the HA category, enabling the company to meet diverse patient needs

ZUG, Switzerland--BUSINESS WIRE--

Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that Restylane Shaype has been approved for temporary augmentation in the chin area and improvement of jawline definition in Mexico.1 This is the product’s first approval globally for the jawline, and further expands its availability for chin augmentation, where it is already approved across various markets globally including Europe, Brazil, Canada and Thailand. Restylane Shaype has been purposefully developed as a firmer gel to deliver a unique bone-mimicking effect and enable natural-looking structural enhancement without surgery.3-6

The lower face plays a pivotal role in overall facial balance, influencing proportions and profile,4 with recent market research conducted by Galderma finding that the chin is the third most treated area in existing HA injectable users.7 In the chin, genetic factors and age-related changes can lead to reduced definition and poor projection.4,8 In the jawline, factors such as aging can contribute to changes in fat layers, which can result in tissue descent and jowling.5 Medication-driven weight loss may further accentuate these changes in the lower face by affecting facial fat distribution.9

In a pivotal 12-month study of Restylane Shaype in the chin, 83% of people showed improved structure and definition at three months (66% at 12 months), and 84% of patients said they would agree to be treated with Restylane Shaype again.4 Furthermore, up to 97% of patients would recommend treatment with Restylane Shaype to a friend.4

Data in the jawline has also shown that Restylane Shaype was superior to no-treatment for restoring and enhancing jawline definition, with durable improvements maintained for up to two years.5 70% of patients reported improved overall satisfaction with their appearance and 82% noted the natural-looking results of the long-lasting treatment option.5 A further study of Restylane Shaype for the jawline shows over 92% would recommend the treatment to a friend and over 90% would choose to receive the treatment again.10

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.1,2,11

 

“In my practice, I see many patients who are looking for effective, long-lasting facial enhancements to address their concerns around structure and facial balance. Having new innovations in injectable treatments that allow us to address these concerns with precision while maintaining natural-looking results is incredibly valuable. Restylane Shaype represents an exciting development for the field, combining a bone-mimicking hyaluronic acid gel with clinical evidence that demonstrates sustained, yet temporary, improvements in facial structure and definition.”

 

DR. OSVALDO VÁZQUEZ

CEO OF SKIN GROUP AND HEAD OF THE DERMATOLOGY DEPARTMENT, HOSPITAL UNIVERSITARIO DR. JOSÉ ELEUTERIO GONZÁLEZ, MEXICO

 

 

Underpinning the Restylane range is a minimally modified HA gel that closely resembles naturally occurring HA. The gel is designed to deliver effective results with less product than other HA gels, and can be readily reversed, providing both performance and reassurance.12-16 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.3

To support consistent, individualized use of Restylane Shaype in clinical practice, Galderma has developed the Shayping Technique™.17 The technique combines Galderma’s Assessment, Anatomy, Range, and Treatment (AART™) methodology and the Facial Assessment Scale (FAS), enabling healthcare professionals to systematically evaluate facial balance, helping to identify individual patient priorities and treatment goals.18,19 This assessment-led approach supports a broader understanding of lower face structure and creates definition for both the jawline and chin.4,5,18,19

 

“We’re thrilled to see this important milestone for Restylane Shaype in Mexico, especially with its first jawline approval worldwide. Restylane Shaype brings an additional innovative approach to structural enhancement in the lower face, expanding the possibilities for clinicians beyond what traditional HA fillers are designed to achieve. This approval further strengthens the Restylane portfolio and reflects Galderma’s commitment to advancing science-based treatments that address evolving patient needs and growing demand for facial balancing and harmonization.”

 

BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D.

GLOBAL HEAD OF R&D

GALDERMA

 

 

Restylane remains highly relevant in addressing some of today’s most significant aesthetic trends and patient needs, including aesthetic concerns related to medication-driven weight loss and menopause. The distinctive bone-mimicking effect of Restylane Shaype demonstrates how the Restylane HA treatment range is uniquely positioned to support facial structure and skin health across all life stages, addressing changes that can affect bone density, structural support, and overall appearance.20-23

Supported by 30 years of innovation and more than 77 million treatments administered worldwide, Restylane has helped define the HA injectable category and continues to shape the future of aesthetic treatment.24-26 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.27,28

About the Restylane portfolio
Restylane HA treatments are designed differently to go beyond volumizing for natural-looking results.2,24,28 Our HA is minimally modified and our innovative manufacturing process preserves its biocompatibility while creating individual products designed for a specific purpose.29-31 Powered by NASHA HD, NASHA®, and OBT™ 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.3,32,33 Trusted for almost three decades, our HA gels work in sync with your skin for 100% natural-looking results.24,34,35 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® Shaype™ Mexico Instructions for Use. November 2026.
  2. Restylane® EU Instructions for Use. July 2026.
  3. Galderma. Data on file. MA-56724. 2023. Global rheology data (xStrain and G´ including Restylane SHAYPE).
  4. 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.
  5. Shridharani S, et al. Effectiveness and Safety of a High G′ Hyaluronic Acid Injectable for Jawline Definition: A Randomized Controlled Clinical Investigation. Dermatol Surg. 2026;00:1–8. doi.org/10.1097/DSS.0000000000005378.
  6. Galderma. Data on file. MA-53870. 2023. Restylane SHAYPE 43BBJ2001 Clinical Study Report.
  7. Galderma. Data on file. Restylane Market Research.
  8. 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.
  9. Humphrey CD & Lawrence AC. Implications of Ozempic and other GLP-1 receptor agonists for facial plastic surgeons. Facial Plast Surg. 2023;39:719-721. doi: 10.1055/a-2148-6321.
  10. Galderma. Data on file. MA-62128. 2026. 43BBJ1911 Clinical Study Report.
  11. Galderma. Data on file. Dekra Restylane Next Generation Syringe Report.
  12. 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.
  13. Nikolis A, et al. The CHEEKY study: effectiveness of cheek treatment with hyaluronic acid fillers HAVOL and HALYF. Poster presented at: AMWC, Monaco. 2022.
  14. Andriopoulos B, et al. Facial augmentation with hyaluronic acid fillers in an Asian population. Poster presented at AMWC, Monaco. 2019.
  15. Jones D, et al. A randomized, comparator-controlled study of HARC for cheek augmentation and correction of midface contour deficiencies J Drugs Dermatol. 2021;20;949–956. doi:10 .36849 /JDD .6191.
  16. 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.
  17. Lundgren B et al. Using a New Photo Scale to Compare Product Integration of Different Hyaluronan-Based Fillers After Injection in Human Ex Vivo Skin. J Drugs Dermatol. 2018;17:982–6. PMID: 30235386.
  18. 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.
  19. Galderma. Data on file. AART Methodology Comprehensive Training Deck 2022.
  20. 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.
  21. 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.
  22. 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.
  23. Galderma. Data on file. MA-56848. 2023. Technical data for Restylane SHAYPE.
  24. 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.
  25. Galderma. Data on file. MA-57232 [Updated]. 77 Million treated.
  26. Galderma. Data on file. MA-55607. Restylane® 27 years data publications analysis.
  27. Galderma. Data on file. Global report: Aesthetics treatments and hyaluronic acid injectables. Consumers & HCPs. 2025.
  28. Galderma. Data on file. MA-48544 Subject satisfaction (GAIS) – NASHA and OBT Fillers. 2021.
  29. Edsman K, et al. Dermatol Surg. 2012;38:1170–1179. doi: 10.1111/j.1524-4725.2012.02472.x.
  30. Galderma. Data on file. MA-58650. Degree of modification of HA fillers.
  31. 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.
  32. 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.
  33. 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.
  34. 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.
  35. 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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