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.
Restylane Kysse is the first hyaluronic acid (HA) filler specifically indicated for the lips using XpresHAn Technology globally referred to as the OBT (Optimal Balance Technology).
XpresHAn Technology products have demonstrated natural-looking results for patients with dynamic facial wrinkles. 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 one year.
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 three trial supporting approval. It was shown to be both safe and well-tolerated and contains lidocaine, a medication used to numb the area to decrease pain and reduce discomfort associated with injections in the lip area.
Restylane Kysse is proven to last for up to one year 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.
“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. “We are confident that Restylane Kysse will become a leading lip filler in the dynamic U.S. market.”
“Restylane Kysse is a game changer with a formulation specifically designed to provide excellent outcomes in the lips,” said Melanie Palm, M.D., board-certified dermatologist and cosmetic surgeon in San Diego, California and a clinical investigator in the Restylane Kysse phase three 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.”