Allergan Aesthetics secures FDA approval for injectable hyaluronic acid innovation
15 May 2023 --- Allergan Aesthetics, an AbbVie company, has gained approval from the US Food and Drug Administration (FDA) for Skinvive by Juvéderm, marketed as the “first and only” hyaluronic acid intradermal microdroplet injection for skin smoothness available in the US.
With results lasting through six months with optimal treatment, the solution improves skin smoothness of the cheeks in adults over the age of 21, leading to a lasting glow, the company claims.
“Skinvive by Juvéderm is a category-creating hyaluronic acid product that leaves skin looking healthier, more glowing and more hydrated,” Carrie Strom, global president of Allergan Aesthetics and senior vice president at AbbVie.
“This unique product is a result of our vast experience in HA science and complements our current collection of hyaluronic acid products, with the Juvéderm Collection of Fillers and SkinMedica topicals."
“Unmet need” in skin quality category
Skinvive by Juvéderm is a specialized, injectable hyaluronic acid 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, notes its manufacturer.
The solution is smooth and 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.
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.
“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,” says Macrene Alexiades, MD, PhD., dual US-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.”
Clinical studies
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 study 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 papules 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.
As sometimes happens with novel products, the FDA has required that Allergan Aesthetics provide a training program for all interested providers. Successful completion of this training is necessary prior to purchase of and administration of Skinvive by Juvéderm.
By Benjamin Ferrer
