Restylane receives FDA approval for lip augmentation

11 Oct 2017

Dermatology company Galderma has announced that its hyaluronic acid dermal filler Restylane Silk has received approval by the US Food and Drug Administration (FDA) for lip augmentation with the use of a small blunt tip cannula.

The FDA conducted a 12-week study to assess the safety and efficacy of Restylane Silk, in conjunction with the use of a small blunt tip cannula for lip augmentation. The study took place in four centres across the US, with 60 male and female subjects aged 23 years of age or older. At 12 weeks, 98% of subjects were observed to have improvement in both the upper and lower lip by the treating investigator, as assessed by the Global Aesthetic Improvement Scale (GAIS), a global 7-point scale for aesthetic improvement in appearance. No severe adverse events were reported following treatment.

Alisa Lask, vice president and general manager of Galderma's US aesthetic and corrective business, said, “A commitment to continuous innovation in support of aesthetic professionals to achieve high patient satisfaction with natural looking results is our core focus.”

Restylane Silk is currently not available in the UK or EU.  

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