Galderma receives new FDA approval for Restylane

15 Nov 2018

The US Food and Drug Administration (FDA) has approved hyaluronic acid dermal filler Restylane Lyft for cheek augmentation and the correction of age-related mid-face contour deficiencies via small blunt tip cannula in patients over the age of 21.

According to international pharmaceutical company Galderma, Restylane Lyft for the mid-face is the only HA filler on the market that is FDA-approved for use via cannula. The approval is the third indication for Restylane Lyft, which is also approved for the nasolabial folds and back of the hands.

"The FDA approval of Restylane Lyft for mid-face via cannula marks the seventh FDA approval in aesthetics for Galderma in the past four years," said Alisa Lask, general manager and vice president of the US aesthetic business at Galderma. She added, "We have increased our investment in research and development this year in order to help grow the aesthetic market. Our goal is to continue to offer new solutions and delivery systems to our customers to help drive new patients in to aesthetic offices."

In a 16-week multicentre, open-label, prospective study with 60 male and female patients 22 years of age or older, 98.3% of patients showed improvement at week 16 in both the right and left mid-face based on the treating investigator's assessment using the Global Aesthetic Improvement Scale (GAIS). No severe adverse events were reported.

Dr Anne Chapas, a board-certified dermatologist in New York City and clinical trial investigator for Restylane Lyft for mid-face injection via cannula stated, "I am thrilled that the FDA has approved Restylane Lyft for mid-face via cannula. I prefer using a cannula vs. a needle when injecting specific areas of the face. This is because, in my experience, the use of a cannula may be associated with less potential damage to blood vessels, can help minimise patient bruising, help decrease swelling, and allow for minimised downtime."


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