HA Filler Now Approved for Cheek Augmentation and Midface Contour Deficiencies

The United States FDA announced that a new hyaluronic acid (HA) dermal filler is now approved for cheek augmentation and for correction of midface contour deficiencies in adults aged 21 years or older.

Approval comes after the results of a randomized, comparator-controlled, multicenter, pivotal phase 3 study into the effectiveness and safety of the HA filler. In total, 270 patients were randomized to either group A, which compared the effectiveness and safety of the HA filler vs a comparator product (n=142), or group B, which compared the HA filler as injected by needle (n=60) on one side of the face vs cannula (n=60) in the other in the same patient.

Results showed that patients who received the new HA filler required less total volume injected to achieve optimal results vs the comparator product. At least 76% of patients in group A who received the HA filler were satisfied with their results across all FACE-Q questions through week 48 vs at least 73% who received the comparator. In group B, 91% were satisfied with their cheeks across all FACE-Q questions through all timepoints through study completion.

Further, the HA filler showed similar efficacy and safety when injected with a needle vs a cannula.

In addition to cheek augmentation and midface contour deficiency correction, the HA filler and its family of products are indicated to treat moderate to severe facial wrinkles and folds and volume loss of the dorsal hand and lip augmentation.

Reference

Galderma receives FDA approval for Restylane^® contour for cheek augmentation and correction of midface contour deficiencies. Press release. Galderma; June 29, 2021. Accessed June 29, 2021. https://prnmedia.prnewswire.com/news-releases/galderma-receives-fda-approval-for-restylane-contour-for-cheek-augmentation-and-correction-of-midface-contour-deficiencies-301321891.html