Global pharmaceutical company Allergan has received US Food and Drug Administration (FDA) approval for the use of Juvéderm VOLUMA XC with a TSK STERiGLIDE cannula for cheek augmentation to correct age-related volume definition in the mid-face in adults over 21.
The approval is the first for the use of cannula using Juvéderm VOLUMA XC, which Allergan has confirmed is the equivalent of Juvéderm VOLUMA in the UK.
According to a 12-week multicentre, split-face, investigator-blinded, non-inferiority study with 60 subjects, results demonstrated comparable performance, safety profile and patient satisfaction between cannula and needle injection.
"As a physician, I have used the Juvéderm collection of fillers for 13 years, so I am thrilled that the FDA has approved the use of cannula with Juvéderm 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," said board-certified dermatologist and clinical trial investigator Dr Dee Anna Glaser.
"At Allergan, we are committed to driving innovation in medical aesthetics as well as providing best-in-class injector training to our customers," said senior vice president of US Allergan Medical Aesthetics, Carrie Strom. She added, "With this approval, Allergan will be able to educate on facial anatomy and injection techniques that will help healthcare providers administer treatment with Juvéderm VOLUMA XC safely to achieve optimal patient satisfaction."