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FDA approves hyaluronic acid lip filler Restylane Kysse


Galderma announces the U.S. Food and Drug Administration has approved hyaluronic acid lip filler, Restylane Kysse, in patients 21 years and older.

The United States Food and Drug Administration (FDA) has approved Restylane Kysse (Galderma), a hyaluronic acid (HA) filler for the lips and upper perioral rhytids in adults over 21 years old. 

The filler is the first to be equipped with Optimal Balance Technology (OBT) or XpresHAn Technology, which uses advanced tissue integration to achieve a more natural look.

Galderma says injectors can expect the Restylane Kysse to produce enhanced lip texture and color, while leaving lips full and soft with results lasting up to 1 year.

“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,” says Alisa Lask, general manager and vice president of the U.S. Aesthetic Business at Galderma. “We are confident that Restylane Kysse will become a leading lip filler in the dynamic U.S. market.”

The May 5 announcement follows positive phase 3 trial results that demonstrate an improvement in lip fullness was achieved with a lower amount of Restylane Kysse (1.82 mL) versus comparator (2.24 mL). Additionally, 78% of patients reported satisfaction with their results after 1 year.1

The most common temporary side effects include masses and nodules, redness, hypersensitivity, bruising and swelling at the injection site.

“Restylane Kysse is a game changer with a formulation specifically designed to provide excellent outcomes in the lips,” says Melanie Palm, M.D., San Diego, Calif., dermatologist, cosmetic surgeon and clinical investigator in the phase 3 trial for Restylane Kysse. “This new approval enables me to provide natural-looking results for my patients’ lips that are apparent when they speak, smile or even kiss.”

Restylane Kysse joins a variety of other aesthetic injectables in Galderma’s portfolio including Restylane Defyne, Restylane Refyne, Restylane Lyft with Lidocaine and Restylane Silk.


1. Galderma Receives FDA Approval for Restylane® Kysse, A New Hyaluronic Acid (HA) Filler Specifically Designed and Indicated to Add Fullness to the Lips and Help Smooth the Wrinkles Above the Mouth. https://www.multivu.com/players/English/8703951-galderma-restylane-kysse-lip-augmentation/. Published May 5, 2020. Accessed May 6, 2020

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