Galderma announces that the U.S. Food and Drug Administration (FDA) has approved Restylane® Kysse for lip augmentation and the correction of upper perioral rhytids (wrinkles around upper lips) in adults over the age of 21.1 Restylane Kysse is the first hyaluronic acid (HA) filler specifically indicated for the lips using XpresHAn Technology™ (pronounced ex-ˈspre-shan') globally referred to as the OBT technology (Optimal Balance Technology). Restylane Kysse is proven to last for up to 1 year1,2 with high levels of patient satisfaction for people with lips that have changed due to the aging process or for those seeking natural-looking, fuller lips.3
"Restylane Kysse is a new lip filler that offers key attributes both providers and their patients desire in a lip injection – high satisfaction, consistent results, and a proven clinical-safety profile," said Alisa Lask, General Manager and Vice President of the U.S. Aesthetic Business at Galderma.3,4,5 "We are confident that Restylane Kysse will become a leading lip filler in the dynamic U.S. market."
XpresHAn Technology™ products have demonstrated natural-looking results for patients with dynamic facial wrinkles.6 Restylane Kysse uses this technology to provide high levels of patient improvement* with 78% of trial patients reporting they were still satisfied with their results after 1 year.3 A lower amount of Restylane Kysse (1.82 mL) was needed to show an improvement in lip fullness** compared to the comparator (2.24 mL) in the Phase 3 trial supporting approval.3 Restylane Kysse was shown to be both safe and well-tolerated.4 It contains lidocaine, a medication used to numb the area to decrease pain and reduce discomfort associated with injections in the lip area.1
"Restylane Kysse is a game changer with a formulation specifically designed to provide excellent outcomes in the lips," said Dr. Melanie Palm, board-certified dermatologist and cosmetic surgeon in San Diego, CA and a clinical investigator in the Restylane Kysse phase 3 trial. "This new approval enables me to provide natural-looking results for my patients' lips that are apparent when they speak, smile or even kiss." 3,4
With over 40 million treatments worldwide and counting, the Restylane® family of HA dermal fillers is the broadest portfolio of dermal fillers in the world.5 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), 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).5
We are working to determine the appropriate launch timing and availability for Restylane Kysse. The health and safety of aesthetic providers, patients and Galderma employees is our utmost priority and will continue to be. To learn more about the Restylane Kysse and the Restylane family of products, visit www.RestylaneUSA.com
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.
1 Restylane Kysse. Instructions for Use. Galderma Laboratories, L.P., 2020.
2 Hilton S, Gerhard S, Berg AK, Samuelson U, Wong C. Randomized, Evaluator-Blinded Study Comparing Safety and Effect of Two Hyaluronic Acid Gels for Lip Enhancement. Dermatol Surg. 2018;44(2):261-269
3 Data on file. 43USK1701 Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2019.
4 Data on File. 05DF1807 Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2020.
6 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
Galderma, PR Newswire