Galderma Announces FDA Approval for Restylane Kysse

Galderma, the largest global independent dermatology company, recently announced Food and Drug Administration (FDA) approval of their newest hyaluronic acid (HA) filler option, Restylane Kysse.

The HA filler is the first of its kind to be indicated specifically for lip augmentation and the correction of upper perioral rhytids using XpresHAn Technology, also globally referred to as Optimal Balance Technology (OBT), according to Galderma’s recent press release announcing the product approval.

Indicated for use in adults over the age of 21, Restylane Kysse uses XpresHAn Technology – demonstrated to show natural-looking results for patients with dynamic facial wrinkles – to provide “high levels of patient improvement with 78% of trial patients reporting they were still satisfied with their results after 1 year,” according to the release .

Notably, in the phase 3 trial, less product was needed for Restylane Kysse vs. the comparator (1.82 mL vs. 2.24 mL) to show an improvement in lip fullness.

With results that last up to 1 year, the filler’s “unique cross-linking of the hyaluronic acid gel… has been specifically developed for the treatment of sensitive lips,” according to Health Pharma. “The hyaluronic acid-based gel softly integrates into the sensitive lip tissue and has been proven to cause little swelling.”

Restylane Kysse contains lidocaine to help decrease pain and discomfort associated with injections to the lips and was shown in trials to be both safe and well-tolerated.

“Restylane Kysse is a game changer with a formulation specifically designed to provide excellent outcomes in the lips,” according to Dr. Melanie Palm, board-certified dermatologist and cosmetic surgeon in San Diego, Cali., and clinical investigator in the Restylane Kysse phase 3 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.”

Adding to Galderma’s portfolio of Restylane HA dermal fillers for the lips, including Restylane, Restylane Silk and Restylane-L, the company is currently determining the appropriate launch date and availability of the product for the current COVID-19 climate, noting in the release, “the health and safety of aesthetic providers, patients and Galderma employees is our utmost priority and will continue to be.”