Allergan Aesthetics, an AbbVie company, has announced that the U.S. Food and Drug Administration (FDA) has approved their SKINVIVE™ by JUVÉDERM®.
SKINVIVE is the first and only hyaluronic acid (HA) intradermal microdroplet injection used to improve skin smoothness of the cheeks in adults aged 21 years and above, with results lasting through six months.
SKINVIVE works by improving the cheeks’ skin quality by smoothing the skin and increasing hydration. It contains a small amount of lidocaine and is approved for all Fitzpatrick Skin Types. SKINVIVE is a minimally invasive treatment involving little-to-no downtime. Results last six months with no additional need for recurring treatments.
The approval comes after a clinical study showed that 58% and 56% of patients treated with SKINVIVE saw a greater than or equal to 1-point improvement on the Allergan Cheek Smoothness Scale (ACSS) at one month and six months respectively.
Patients were also given a questionnaire in which 63% reported they were satisfied with how radiant their facial skin looked at six months of treatment with SKINVIVE. A total of 72% reported satisfaction with their skin’s hydration at six months and 83% at how healthy their skin looked.
Many of the patients involved in the study reported side effects including redness, lumps and bumps, swelling, bruising, tenderness, pain, firmness, discoloration, and itching at the injection site. These were usually mild or moderate, but some reported more severe side effects. Typically these went away within 30 days, with few experiencing longer-lasting effects.
Macrene Alexiades, MD, PhD, SKINVIVE by JUVEDERM’s lead investigator and author of the clinical trial published in Dermatologic Surgery, has stated,
The FDA has required that Allergan Aesthetics provide training for all those interested in providing SKINVIVE to their patients. It is necessary for them to successfully complete this training before the purchase and administration of SKINVIVE.
SKINVIVE is expected to be commercially available within the next six months.