Galderma Announces Triple Approval of New State-of-the-Art Restylane® Syringe in the EU, the U.S., and Canada, Reaffirming the Company's Position at the Forefront of Injectable Aesthetics

Business Wire India

Regulatory authorities in the European Union (EU), the United States (U.S.), and Canada have approved a new state-of-the-art Restylane® syringe for use with a range of Restylane NASHA® lidocaine products in multiple indications in the face and in the hands^1-3
Developed in collaboration with aesthetic practitioners, its innovative ergonomic design features a cushioned finger grip and thumb rest, to improve practitioner experience through better injection comfort and control, helping them deliver consistently premium results ^4-7
The syringe’s carton packaging is the first in the industry to be made from 100% recyclable paper, and reaffirms Galderma’s commitment to sustainability and environmental responsibility ⁸
These approvals demonstrate Galderma’s strong heritage in Injectable Aesthetics, and its commitment to continuing to drive innovation in the field

Galderma (SIX: GALD), today announced that regulatory authorities in the EU, the U.S., and Canada have approved a new state-of-the-art syringe for use with its NASHA^® lidocaine range of Restylane products in multiple facial indications including the cheeks, nose, chin, jawline, tear troughs, nasolabial folds, marionette lines, as well as in the hands.^1-3

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The syringe features a next-generation ergonomic design that enhances precision and control; includes an optimized syringe-needle connection with the new Terumo K-Pack Enhance™ needle; and offers a premium color-coded packaging and syringe design to support easy range navigation for practitioners.^{4-7, 9,10} It sets a new standard in Injectable Aesthetic devices and demonstrates Galderma’s unwavering commitment to driving innovation to meet the needs of both practitioners and patients.

“Developing this new syringe in close collaboration with practitioners to address their specific needs has really set it apart. Repetitive hand movements like performing numerous injections every day can lead to strain and reduced mobility, but the syringe’s ergonomic design, with a cushioned finger grip and thumb rest ensure maximum comfort when injecting, supporting consistent, high‑quality results for patients.”

DR. LUDDI LUIZ OLIVEIRA

PLASTIC SURGEON

BRAZIL

Designed in collaboration with over 70 aesthetics practitioners, the next-generation Restylane syringe was optimized for ergonomic functionality, ease of aspiration, ease of operation, and a premium look and feel, resulting in an innovative syringe that supports practitioners with delivering premium results.^4,5,7,9Additionally, the syringe was designed with sustainability in mind, with compact paper-only carton packaging that is 100% recyclable and reduces in-clinic waste by up to 30% based on volume reduction.^8,11

Galderma’s versatile Restylane portfolio is the only hyaluronic acid (HA) range offering four distinct technologies, NASHA^®, NASHA HD™, OBT™, and SB-NASHA™, that offer firmer gels that provide contouring and structural support, to soft, flexible formulations that smooth facial lines and wrinkles for a more youthful look.^12-19With HA closest to the skin’s own, it is designed to deliver personalized, natural-looking outcomes that provide contour, definition, and hydration, meeting diverse patient needs across key areas of the face, décolletage, and in the hands.^12-15,20-22 The new state-of-the-art syringe represents the next step in Restylane’s evolution, with a novel way to deliver its trusted premium results.

“This next-generation syringe reflects the latest advancements in injection design, giving aesthetic practitioners greater precision, improved ergonomics, and enhanced control. By refining every element of the injector experience, we aim to help clinicians deliver consistently premium results for their patients. Through direct collaboration with practitioners, Galderma continues to push the boundaries of aesthetic innovation, and we remain steadfast in our commitment to driving the field forwards."

BALDO SCASSELLATI SFORZOLINI, M.D., PH.D.

GLOBAL HEAD OF R&D

GALDERMA

The next-generation syringe is now approved for use in the EU, the U.S., and Canada with the NASHA^® lidocaine range of Restylane products including, Restylane Lyft™ Lidocaine, Restylane Eyelight™ and Restylane-L™ (known as Classyc™ Lidocaine in some markets).^1-3

With over 30 years of innovation and more than 77 million treatments administered worldwide, Restylane’s has an iconic heritage as a trusted, science-backed HA treatment that consistently delivers premium results.^23,24 Building on this heritage, the new state-of-the-art Restylane syringe demonstrates Galderma’s continued innovation, and solidifies its position at the forefront of aesthetics.

About the Restylane portfolio

Restylane HA treatments are designed differently to go beyond volumizing for natural-looking results.^21,25-27 Our HA is minimally modified and our innovative manufacturing process preserves its biocompatibility while creating individual products designed for a specific purpose.^28-31Powered 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.^12-19 Trusted for almost three decades, our HA gels work in sync with your skin for 100% natural-looking results.^12,21,22

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.		Galderma. Data on file. U.S. FDA Restylane syringe PMA supplement approval letter
2.		Galderma. Data on file. Health Canada Restylane Medical Device License
3.		Galderma. Data on file. Dekra Restylane next generation syringe report
4.		Galderma. Data on file. MA-64737
5.		Galderma. Data on file. MA-56005
6.		Galderma. Data on file. Restylane next generation syringe HCP survey
7.		Galderma. Data on file. Design and development of the next generation syringe
8.		Galderma. Data on file. Vimer S.r.l. Declaration of recycling compliance. 2025
9.		Galderma. Data on file. MA-59168
10.		Galderma. Data on file. MA-65164
11.		Galderma. Data on file. MA-63907
12.		Solish N, et al. Dynamics of hyaluronic acid fillers formulated to maintain natural facial expression. J Cosmet Dermatol. 2019;18(3):738-746. doi: 10.1111/jocd.12961.
13.		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.
14.		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.
15.		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.
16.		Nikolis A, et al. A new NASHA-HD, high G’ hyaluronic acid (HA) injectable evaluated for chin treatment in combination with lower face and mid-face HA filler treatment. Poster presented at IMCAS 2026; January 29-31, 2026; Paris, France.
17.		Rivers J, et al. Effectiveness and safety of Restylane® Lyft™ Lidocaine for jaw-line definition: A 12-month randomized controlled study. Poster presented at IMCAS 2026; January 29-31, 2026; Paris, France.
18.		Moradi A, et al. Effectiveness and safety of a hyaluronic acid skin quality injectable for the correction of wrinkles in the décolletage area. Poster presented at IMCAS 2026; January 29-31, 2026; Paris, France.
19.		Nestor, M. Safety and effectiveness of an OBT™ hyaluronic acid filler for temple hollowing treatment: a randomized, controlled, clinical investigation. Poster presented at IMCAS 2026; January 29-31, 2026; Paris, France.
20.		Galderma Data on file. MA-56724. X-strain and G’ including Shaype.
21.		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.
22.		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):1600-1606. doi: 10.1111/jocd.13205.
23.		Galderma. Data on file. MA-57232 [Updated]. 77 Million treated.
24.		Fabi SG, et al. The potential role of biostimulators/dermal fillers to address menopause-related skin conditions. Poster presented at IMCAS 2026; January 29-31, 2026; Paris, France.
25.		Restylane. U.S. Instructions for use. Available online. Accessed January 2026.
26.		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. doi: 10.1093/asjof/ojaa005.
27.		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 (12):1361–1369. doi: 10.1097/DSS.0000000000000549.
28.		Galderma. Data on file. Global report: Aesthetics treatments and hyaluronic acid injectables. Consumers & HCPs. 2025.
29.		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.
30.		Galderma. Data on file. MA-58650. Degree of modification of HA fillers.
31.		Seo KK. Facial volumization with fillers. Springer. 2021;29–83. doi: 10.1007/978-981-33-6212-3_2.