SKINVIVE™ by JUVÉDERM® Receives U.S. FDA Approval

Allergan Aesthetics announced the U.S. FDA approval of SKINVIVE by JUVÉDERM to improve skin smoothness of the cheeks in adults over the age of 21. SKINVIVE by JUVÉDERM is the first and only hyaluronic acid (HA) intradermal microdroplet injection for skin smoothness available in the U.S. with results lasting through six months with optimal treatment.

SKINVIVE by JUVÉDERM is a smooth, injectable HA gel that contains a small amount of local anaesthetic (lidocaine). Unlike other facial injectables that enhance and augment the treatment area, SKINVIVE by JUVÉDERM improves skin quality in the cheeks by smoothing the skin and increasing hydration.

SKINVIVE by JUVÉDERM is a specialized, smooth, hydrating gel that is absorbed easily into the skin and is approved for all Fitzpatrick Skin Types I-VI, lightest to darkest, addressing an important unmet need in the skin quality category. The product was designed by global skin health experts to improve the smoothness of the cheeks leading to a lasting glow.

In a randomized, multicenter, evaluator-blinded, controlled pivotal clinical study, 58% and 56% of patients treated with SKINVIVE by JUVÉDERM saw a ≥ 1 point improvement on the Allergan Cheek Smoothness Scale (ACSS) at one month and six months respectively. In a patient-reported satisfaction with skin questionnaire, 63% of patients were satisfied with how radiant their facial skin looked at six months compared with 11% before treatment.

At six months, 72% were satisfied with how hydrated their facial skin looked at six months compared to 24% before treatment. Additionally, 69% were satisfied with how refreshed their facial skin made them look at six months compared to 16% before treatment. At month six, 83% were satisfied with how healthy their facial skin looked compared to 38% before treatment.

References:

1. ^{SKINVIVE™ by JUVÉDERM® Patient Label 2023.}
2. ^{Safa M., Natalizio A., Hee, CK. A Prospective, Open-Label Study to Evaluate the Impact of VYC-12L Injection on Skin Quality Attributes in Healthy Volunteers. Clinical, Cosmetic and Investigational Dermatology. 2022.}
3. ^{SKINVIVE™ by JUVÉDERM® Directions for Use 2023.}
4. ^{Nakab L., Hee CK, Guetta O. Improvements in Skin Quality Biological Markers in Skin Explants Using Hyaluronic Acid Filler VYC-12L. Plastic Reconstr Surg Glob Open. 2020.}