Galderma Receives FDA Approval for Restylane® Defyne for Chin Augmentation

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 subjects^† 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,^5,6,7,8” 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 natural, dynamic movement.^9,10 Treatment with Restylane Defyne in the lower face, using XpresHAn Technology™, has shown to produce highly satisfactory natural looking resullts.^4,11

“This marks Galderma’s 8^th FDA aesthetics approval in 5 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 Technology^TM 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 96% 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 participants, which extends to participants of all skin types^§, male subjects and subjects 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 country.

For more information about Restylane Defyne for chin, visit RestylaneUSA.com.