The Food and Drug Administration (FDA) has approved Restylane® Kysse (Galderma) for lip augmentation and the correction of upper perioral rhytids in adults aged >21 years.

Restylane Kysse is a sterile, clear gel formulation of hyaluronic acid that contains 3mg/mL of lidocaine hydrochloride. The approval was based on data from a randomized, controlled, evaluator-blinded, multicenter phase 3 study that compared the efficacy and safety of Restylane Kysse to control in 273 patients for lip augmentation and correction of upper perioral rhytids. 

Patients were randomized 2:1 to receive either Restylane Kysse or control. Results showed that Restylane Kysse met the primary end point of noninferiority with a mean change from baseline Medicis Lip Fullness Scale (MLFS) score of 1.8 for both the upper and lower lips vs the control group with an upper lip MLFS score of 1.7 and lower lip score of 1.8. 

Additionally, patients showed high levels of improvement when treated with Restylane Kysse using the Global Aesthetic Improvement Scale (GAIS). At week 8, 96% (n=170/178) of patients reported their upper and lower lips, separately and combined, as “improved” or better, and the improvement was maintained through week 48 in 78% (n=132/169) of patients. Moreover, a lower amount of Restylane Kysse (1.82mL) was needed to show an improvement in lip fullness compared with the control (2.24mL).

With regard to safety, the most common treatment-related adverse events were injection site mass, bruising, and nodules; no serious adverse events reported. As with all transcutaneous procedures, dermal filler implantation carries a risk of infection.

Related Articles

“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.

Restylane Kysse is part of a family of aesthetic medicine products that include Restylane®, Restylane-L®, Restylane® Lyft with Lidocaine, Restylane® Silk, Restylane® Refyne, and Restylane® Defyne.

For more information