Healthcare Industry News:  Restylane Silk 

Devices Dermatology FDA

 News Release - February 1, 2021

Galderma Receives FDA Approval for Restylane(R) Defyne for Chin Augmentation

Represents second approved indication for Restylane Defyne in U.S.; expands Galderma Aesthetics' growing Restylane product portfolio

FORT WORTH, Texas, Feb. 1, 2021 -- (Healthcare Sales & Marketing Network) -- 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 8th 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 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 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.

About Galderma's Restylane Product Portfolio

The FDA approval of Restylane Defyne for chin adds to Galderma's growing Restylane product portfolio. With over 40 million treatments worldwide and counting, the Restylane family of HA dermal fillers is the most diverse broadest portfolio of dermal fillers in the U.S.13 The portfolio of products help to smooth facial wrinkles and folds, such as smile lines (Restylane L, Restylane Refyne, Restylane Defyne and Restylane Lyft with Lidocaine), augmentation and correction of mild to moderate chin retrusion (Restylane Defyne for Chin), create fuller and more accentuated lips (Restylane Silk, Restylane-L and Restylane Kysse), and add lift and volume to the cheeks and the back of the hands (Restylane Lyft with Lidocaine).13

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/us.

To earn exclusive rewards, bonuses and discounts on Galderma's aesthetic treatments, join the ASPIRE Rewards program. To learn more about ASPIRE, visit www.aspirerewards.com.

Follow Galderma on Instagram at @GaldermaAestheticsUSA.

IMPORTANT SAFETY INFORMATION

The Restylane family of products are indicated for patients over the age of 21, and includes Restylane®, Restylane-L®, Restylane® Lyft with Lidocaine, Restylane® Silk, Restylane® Refyne, Restylane® Defyne and Restylane® Kysse.

APPROVED USES

Restylane® and Restylane-L® are for mid-to-deep injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Restylane® and Restylane-L® are also indicated for injection into the lips.

Restylane® Lyft with Lidocaine is for deep implantation into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and for cheek augmentation and for the correction of age-related midface contour deficiencies. Restylane® Lyft with Lidocaine is also indicated for injection into the dorsal hand to correct volume loss.

Restylane® Silk is for lip augmentation and for correction of perioral wrinkles.

Restylane® Kysse is for lip augmentation and for correction of upper perioral wrinkles.

Restylane® Refyne is for mid-to-deep injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.

Restylane® Defyne is 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. Restylane® Defyne is also indicated for injection into the mid-to deep dermis (subcutaneous and/or supraperiosteal) for augmentation of the chin region to improve the chin profile in patients with mild to moderate chin retrusion.

Do not use if you have severe allergies with a history of severe reactions (anaphylaxis), are allergic to lidocaine or gram-positive bacterial proteins used to make hyaluronic acid, prone to bleeding, or have a bleeding disorder. The safety of use while pregnant or breastfeeding has not been studied. Tell your doctor if you have a history of scarring or pigmentation disorders as these side effects can occur with hyaluronic acid fillers. Tell your doctor if you are planning other cosmetic treatments (i.e., lasers and chemical peels) as there is a possible risk of inflammation at the injection site.

Tell your doctor if you're taking medications that lower your body's immune response or affect bleeding, such as aspirin or warfarin, as these medications may increase the risk of bruising or bleeding at the gel injection site. Using these products on gel injection sites with skin sores, pimples, rashes, hives, cysts, or infections should be postponed until healing is complete.

The most common side effects are swelling, redness, pain, bruising, headache, tenderness, lump formation, itching at the injection site, and impaired hand function. Serious but rare side effects include delayed onset infections, recurrence of herpetic eruptions, and superficial necrosis at the injection site. The risk of unintentional injection into a blood vessel is small but can occur and could result in serious complications, which may be permanent including, vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. As with all skin injection procedures, there is a risk of infection.

To report a side effect with any Restylane® product, please call Galderma Laboratories, L.P at 1-855-425-8722.

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.

†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."

1 Restylane Defyne. Instructions for Use. Fort Worth, TX: Galderma Laboratories, L.P., 2021.

2 Yelp. Yelp Economic Average Report. Q2 2020.

3 Data on file. 43USCH1702 Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2020.

4 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.

5 Fanous N, et al. Estimating Implant Size in Chin Augmentation: A Simplified Approach. Can J Plast Surg. 2003;11(3):161-165.

6 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.

7 Grammer K, et al. Darwinian Aesthetics: Sexual Selection and the Biology of Beatuy. Biol Rev Camb Philos Soc. 2003;78(3):385-407.

8 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.

9 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.

10 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.

11 Milutinovic J, et al. Evaluation of Facial Beauty Using Anthropometric Proportions. Scientific World Journal. 2014: 428250.

12 Data on file. MA-45523 Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2020.

13 Data on file MA:39680. Fort Worth, TX: Galderma Laboratories, L.P., 2019.


Source: Galderma

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