Allergan plc 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 anesthetic (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 flows 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 with global skin health experts to improve smoothness of the cheeks leading to a lasting glow.

Treatment is minimally invasive, offers little to no downtime, and provides results over the course of six months without requiring a recurring series of treatments. In a European post-marketing study, changes in aquaporin were observed after SKINVIVE™ by JUVÉDERM® treatment. Aquaporin is a hydration marker that facilitates the flow of water and glycerol into and out of cells.

Increases in aquaporin may signal an increase of skin hydration. Allergan Aesthetics is looking to pursue further research to better understand the significance of the changes in aquaporin observed after SKINVIVE™ by JUVÉDERM® treatment, as demonstrated in both an ex vivo study4 of human skin samples and an in-situ study of the volar forearms of healthy volunteers. In a randomized, multicenter, evaluator-blinded, controlled pivotal clinical study, 58% (73/125) and 56% (69/124) 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% (78/124) 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% (86/124) were satisfied with how refreshed their facial skin made them look at six months compared to 16% before treatment.

At month six, 83% (103/124) were satisfied with how healthy their facial skin looked compared to 38% before treatment. Allergan Aesthetics anticipates that SKINVIVE™ by JUVÉDERM® will be broadly commercially available within the next six months.