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May 16, 2023

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

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Allergan Aesthetics, an AbbVie company (NYSE: ABBV), 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.3 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.


“SKINVIVE™ by JUVÉDERM® is a category-creating HA product that leaves skin looking healthier, more glowing, and more hydrated,” said Carrie Strom, President, Global Allergan Aesthetics and Senior Vice President, AbbVie. “This unique product is a result of our vast experience in HA science and complements our current collection of HA products, with the JUVÉDERM® Collection of Fillers and SkinMedica® topicals.”


“Skin quality is among the top concerns my patients express when seeking aesthetic treatments. It’s an extremely important factor I consider in my therapeutic process of restoring their natural beauty and appearance,” said Macrene Alexiades, M.D., Ph.D., dual U.S.-EU board-certified dermatologist, SKINVIVE™ by JUVÉDERM® lead investigator, and author of the clinical trial published in Dermatologic Surgery. “One key way to improve skin quality is by enhancing hydration. SKINVIVE™ by JUVÉDERM® is truly innovative because it works beneath the skin’s surface to increase skin hydration improving skin quality. I am excited to add this unique offering to my dermatologic treatment regimen for my patients.”


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.


The majority of subjects in the clinical study reported experiencing side effects such as redness, lumps/bumps, swelling, bruising, tenderness, pain, firmness, discoloration, and itching at the injection sites, as reported in their 30-day daily diaries. These side effects were usually mild (causing little discomfort and no effect on daily activities) or moderate (causing some discomfort and effect on daily activities) in severity, although a few participants experienced severe side effects (causing great discomfort and effect on daily activities). Investigators also reported needle abrasion and papule at the injection site. While rare, some participants experienced side effects that lasted longer than 30 days; however, most side effects went away on their own within 30 days.


*Glow was reported by patients using a validated scale that included satisfaction with how radiant their skin looked.
†Optimal treatment with SKINVIVE™ by JUVÉDERM® may require an optional touch-up one month after initial treatment to achieve the desired aesthetic outcome and is dependent on patient need.

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