Restylane Kysse receives FDA approval
Published
18th May 2020
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Galderma’s Restylane Kysse has been approved by the FDA for lip augmentation and the correction of upper perioral rhytids in adults aged 21 and above.
The hyaluronic acid filler contains 3mg/mL of lidocaine hydrochloride and is part of the Restylane range, which includes Restylane Classic, Lyft, Refyne, Fynesse, Volyme, Defyne; and skin boosters Vital and Vital Light.
The FDA approval was based on a randomised, controlled, evaluator-blinded, multicentre phase 3 study involving 273 patients.
“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 US Aesthetic Business at Galderma.
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