Represents second approved indication for Restylane® DEFYNE™ in U.S.
Expands Galderma Aesthetics’ growing RESTYLANE® product portfolio
Lausanne, Switzerland – February 1st , 2021 – Galderma announces that the U.S. Food and Drug Administration (FDA) has approved Restylane® DEFYNE™ for the augmentation and correction of mild to moderate chin retrusion for adults over the age of 21.1 In 2020 alone, online searches for chin enhancement increased by 185 percent, reinforcing the emerging patient need for a product like Restylane® DEFYNE™.2 Restylane® DEFYNE™ is the first and only chin filler to demonstrate results* across a wide range of participants†, including participants† with all skin types§, male subjects† and subjects† over the age of 52.3 Restylane® DEFYNE™ is a hyaluronic acid (HA) dermal filler that was first approved in 2016 by the FDA for mid-to-deep injection into the facial tissue for the correction of moderate to severe deep facial wrinkles and folds, such as nasolabial folds, in patients† over age 21.1.4
“My patients often come to me asking about new treatment options to continue looking their best. Many are surprised when I explain the impact of chin augmentation and how balancing the lower face is key to helping achieve total facial attractiveness,5-8” said Anne Chapas, M.D., a board-certified dermatologist and dermatologic surgeon in New York and an investigator in clinical trials of RESTYLANE® DEFYNE™ for chin. “The lower part of the face is constantly in motion, so it is important for patients to have the option of a dynamic filler like Restylane® DEFYNE™ that is scientifically developed to adapt to their facial expressions.4,10”
Restylane® DEFYNE™ is the only FDA-approved filler designed for use in the chin that is produced using Galderma’s unique manufacturing process, XpresHAn Technology™, globally referred to as the OBT technology (Optimal Balance Technology), which creates a smooth, injectable gel that integrates into the skin for a natural, defined look9,10, Treatment with Restylane® DEFYNE™ in the lower face, using XpresHAn Technology™, has shown to produce highly satisfactory natural looking results.4,11
“This marks Galderma’s ninth FDA aesthetics approval in five years, illustrating our long-term commitment to advancing aesthetics through new innovation,” said Alisa Lask, General Manager and Vice President of the U.S. Aesthetics Business at Galderma. “The chin is the foundational anchor of the face that brings the rest of your features into balance.8 Consumers can now address the chin with a non-surgical, safe option from a brand that uses cutting-edge XpresHAn TechnologyTM to shape and produce long-lasting results.”
The FDA approval of Restylane® DEFYNE™ for chin is supported by data demonstrating that the product has a proven safety and tolerability profile1 and was well-tolerated for chin enhancement.3 Results of a pivotal Phase 3 clinical trial showed that most patients† (74%) experienced significantly improved chin projection for up to 1 year as measured by the Galderma Chin Retrusion Scale (GCRS)**, and 86% of patients† when asked at 12 weeks.3 Positive aesthetic outcomes following treatment were demonstrated through high levels of subject satisfaction in FACE-Q*** and Global Aesthetic Improvement Scale (GAIS)**** questionnaires. 99% of patients† reported improvement in the appearance of their chin projection (when asked at 12 weeks), while 100% of injectors‡ said treatment improved the appearance of patients’† chin projection up to 1 year.3**** In the Phase 3 clinical trial, Restylane® DEFYNE™ had a proven safety and tolerability profile.1 86% of patients† did not experience any adverse events related to the treatment.3 96% of adverse events related to the treatment were mild in severity (23/24), with only one moderate event of injection site pain.3 Restylane® DEFYNE™ is the first and only chin filler to demonstrate results* across a wide range of patients, which extends to patients of all skin types,§ male patients and patients over 52 years old.3†
Availability of Restylane® DEFYNE™ for Chin
Restylane® DEFYNE™ has been used in over 2.4 million aesthetic treatments worldwide since the market introduction in 2010 and is approved in over 70 countries.12 While Restylane® DEFYNE™ has been available in the United States for 4 years and outside of the U.S. for nearly 10 years, Galderma will work closely with its aesthetic injector partners, while following all safe and proper social distancing guidelines, to introduce the newest offering with Restylane® DEFYNE™ for chin in respective practice locations across the U.S.
For more information about Restylane® DEFYNE™ for chin, visit RestylaneUSA.com.
About Galderma’s RESTYLANE® Product Portfolio
RESTYLANE® is the original non-animal stabilized HA filler with over 24 years of experience and over 40 million treatments worldwide. NASHA™ and OBT™ technologies make RESTYLANE®the world’s most diverse range of fillers to deliver truly individualized results.
The RESTYLANE® portfolio of products includes RESTYLANE®, Restylane® LYFT™, Restylane® KYSSE™, Restylane® VOLYME™, Restylane® DEFYNE™, Restylane® REFYNE™, and Restylane® SKINBOOSTERS™.
About Galderma
Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetic solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com.
For more information
Investor and media relations
Christian Marcoux, M.Sc.
Chief Communications Officer
christian.marcoux@galderma.com
+41 21 642 71 99
Media
Sébastien Cros
Director, Global Communications
+41 21 642 76 94
Isabella Laihorinne Smedh
PR & Communications, Galderma
†Patient=Clinical trial subject
‡Injector=Clinical trial investigator
§Fitzpatrick skin types grouped for analysis (I-III, IV, and V-VI)
*Based on primary analyses of the primary endpoint** for skin type§ subgroups and ad-hoc analyses for gender (male/female) and age (20-29, 30-50, and >50 years) subgroups at Week 12.
** ≥1 grade improvement in chin projection based on the Galderma Chin Retrusion Scale (GCRS).
*** FACE-Q rating of ‘very satisfied’ or ‘somewhat satisfied’ with questions
**** GAIS (Global Aesthetic Improvement Scale) rating of “improved,” “much improved” and “very much improved”
To learn more about serious but rare side effects and full Important Safety Information, visit www.RestylaneUSA.com.
©2021 Galderma. All Rights Reserved. All trademarks are the property of their respective owners.
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REFERENCES
- Restylane DEFYNE. Instructions for Use. Fort Worth, TX: Galderma Laboratories, L.P., 2021.
- Yelp. Yelp Economic Average Report. Q2 2020.
- Data on file. 43USCH1702 Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2020. Restylane DEFYNE. Instructions for Use. Fort Worth, TX: Galderma Laboratories, L.P., 2021.
- Philipp-Dormston WG, Wong C, Schuster B, Larsson M, Podda M. Evaluating perceived naturalness of facial expression after fillers to the nasolabial folds and lower face with standardized video and photography. Dermatol Surg. 2018;44(6):826-832
- Fanous N, et al. Estimating Implant Size in Chin Augmentation: A Simplified Approach. Can J Plast Surg. 2003;11(3):161-165.
- Naini FB, et al. Assessing the Influence of Chin Prominence on Perceived Attractiveness in the Orthognathic Patient, Clinician and Layperson. Int J Oral Maxillofac Surg. 2012;41(7):839-46
- Grammer K, et al. Darwinian Aesthetics: Sexual Selection and the Biology of Beauty. Biol Rev Camb Philos Soc. 2003;78(3):385-407
- Vanaman Wilson MJ, et al. Role of Nonsurgical Chin Augmentation in Full Face Rejuvenation: A Review and Our Experience. Dermatol Surg. 2018;44(7):985-993.
- Lundgren B, Sandkvist U, Bordier N, 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(9):982-986
- Segura, S, Anthonioz L, Fuchez F, Herbage B. A complete range of hyaluronic acid filler with distinctive physical properties specifically designed for optimal tissue adaptations. J Drugs Dermatol. 2012;11(1Suppl):s5-s8.
- Milutinovic J, et al. Evaluation of Facial Beauty Using Anthropometric Proportions. Scientific World Journal. 2014: 428250.
- Data on file. MA-45523 Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2020.