Galderma's Restylane Silk Approved for Injection via Cannula for Lip Augmentation

Thursday, October 12, 2017 | FDA Approval/Clearance , Fillers & Injectables , Product Launches and Updates , Galderma


The FDA approved the use of a small blunt tip cannula with Restylane Silk for lip augmentation. Galderma's Restylane Silk was the first FDA-approved hyaluronic acid (HA) dermal filler specifically designed for lip augmentation and the smoothing of wrinkles around the mouth in patients 21 years of age and older and is now the first HA dermal filler to be approved for lip injection via cannula. This approval for Restylane Silk expands the array of approved lip injection techniques for medical professionals.

A multicenter, open-label, prospective study was conducted to assess the safety and efficacy of Restylane Silk in conjunction with the use of a small blunt tip cannula for lip augmentation. The 12-week study took place in four centers across the US, with 60 male and female subjects 23 years of age or older. At 12 weeks, 98 percent 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.

Following treatment, no severe related adverse events were observed. Furthermore, a vast majority of subjects (81.7 percent) did not experience a treatment emergent adverse event (TEAE). The majority of reported subject diary symptoms were assessed as mild, with the exception of swelling, and the vast majority of all subject diary symptoms were resolved within seven days.

"In the ever-evolving landscape of aesthetic procedures, medical professionals are continuously looking for new tools and treatment options to ensure our patients are receiving optimal treatment outcomes for their specific needs," said Sabrina Fabi, MD, a San Diego-based Dermatologist. "The ability to use a cannula is a welcome addition to my toolkit, as studies have shown that a small blunt tip cannula demonstrates a suitable safety profile, while achieving the desired fullness to the upper and lower lips."

"A commitment to continuous innovation in support of aesthetic professionals to achieve high patient satisfaction with natural looking results is our core focus," said Alisa Lask, VP & General Manager of Galderma's US Aesthetic & Corrective business. "The Restylane family currently offers the broadest offering of HA facial dermal fillers in the U.S. With the launch of Restylane Refyne and Restylane Defyne earlier this year and this new approval, 2017 is an exciting year for patients and aesthetic professionals who use the Restylane brands."

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