DUBLIN – Allergan plc (NYSE: AGN) announced today it received U.S. Food and Drug Administration (FDA) approval for the use of Juvederm VOLUMA XC, a hyaluronic acid gel dermal filler, with a TSK STERiGLIDE cannula for cheek augmentation to correct age-related volume deficit in the mid-face in adults over 21.
A cannula is a thin, flexible tube with a rounded tip that can serve as an effective delivery system. Use of a cannula allows for injection of Juvederm VOLUMA XC in the cheek area. The TSK STERiGLIDE has a unique design compared to other cannulas available on the market and features a patented tip design with a near-tip delivery port for precise product placement.
As a physician, I have used the Juvederm Collection of Fillers for 13 years, so I am thrilled that the FDA has approved the use of cannula with Juvederm VOLUMA XC for mid-face volume deficit. With this latest approval, I have another effective option to provide volume and contour in the mid-face area. I can tailor my treatment approach for each patient while safely providing the aesthetic outcomes they wish to achieve,’ says Dr. Dee Anna Glaser, a board-certified dermatologist in St. Louis and clinical trial investigator.
‘At Allergan, we are committed to driving innovation in medical aesthetics as well as providing best-in-class injector training to our customers,’ says Carrie Strom, Senior Vice President of U.S. Allergan Medical Aesthetics. ‘With this approval, Allergan will be able to educate on facial anatomy and injection techniques that will help healthcare providers administer treatment with Juvederm VOLUMA XC safely to achieve optimal patient satisfaction.’
A multicenter, split-face, investigator-blinded, non-inferiority study was performed to assess the safety and effectiveness of Juvederm VOLUMA XC for correction of age-related volume deficit in the mid-face with the use of a TSK STERiGLIDE cannula versus a needle. The 12-week study took place in seven sites across the U.S. with 60 subjects. All subjects completed the study. Results demonstrated comparable performance, safety profile and patient satisfaction between cannula and needle injection.
Within the Juvederm Collection of Fillers, this is the first approval for the use of cannula. Juvederm VOLUMA XC was first approved by the FDA in 2013 and is formulated with Allergan’s proprietary VYCROSS technology, which blends different molecular weights of hyaluronic acid, contributing to the gel’s duration and is proven to last in the mid-face area for up to 24 months with optimal treatment. Juvederm VOLUMA XC is currently the best-selling Juvederm product in the US.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology. As part of its approach to delivering innovation for better patient care, Allergan has built one of the broadest pharmaceutical and device research and development pipelines in the industry.
With colleagues and commercial operations located in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.