Galderma announces that the US Food and Drug Administration (FDA) has approvedย Restylane Kysseย for lip augmentation and the correction of upper perioral rhytids (wrinkles around upper lips) in adults over the age of 21.

Restylane Kysseย is a hyaluronic acid (HA) filler specifically indicated for the lips usingย XpresHAn Technology (pronouncedย ex-หˆspre-shan’), globally referred to as the OBT technology (Optimal Balance Technology). It is proven to last for up to 1 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, according to the company in a news release.

“Restylane Kysseย is a new lip filler that offers key attributes both providers and their patients desire in a lip injection โ€“ ย high satisfaction, consistent results, and a proven clinical-safety profile,” says Alisa Lask, General Manager and Vice President of the US Aesthetic Business at Galderma, in the release. “We are confident thatย Restylaneย Kysseย will become a leading lip filler in the dynamic US market.”

XpresHAn Technology products have demonstrated natural-looking results for patients with dynamic facial wrinkles. Restylane Kysseย 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. A lower amount ofย Restylane Kysseย (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.

Restylane Kysseย was shown to be both safe and well-tolerated. It contains lidocaine, a medication used to numb the area to decrease pain and reduce discomfort associated with injections in the lip area, the release explains.

“Restylane Kysseย is a game changer with a formulation specifically designed to provide excellent outcomes in the lips,” says Dr Melanie Palm, board-certified dermatologist and cosmetic surgeon inย San Diego, CAย and a clinical investigator in theย Restylane Kysseย phase 3 trial, in the release. ย 

“This new approval enables me to provide natural-looking results for my patients’ lips that are apparent when they speak, smile or even kiss.”

[Source(s): Galderma, PR Newswire]