AbbVie's aesthetics unit is growing its product catalog once again with a new FDA approval.The product, called Skinvive, nabbed an FDA nod this week and falls within Allergan’s Juvederm dermal filler collection.
Skinvive works by injecting hyaluronic acid (HA), plus a small amount of lidocaine, into facial skin to increase hydration while smoothing. The delivery mechanism is the first of its kind and “flows easily into the skin,” creating a “lasting glow,” Allergan said in a recent release.
Skinvive got the green light for use in adults over the age of 21 with all Fitzpatrick skin types I-VI covered, a skin classification scale that ranges from light to dark. Its effects last six months and the procedure requires little to no downtime, according to the company.
The approval was supported by a pivotal clinical study in which 58% of patients saw their skin improve by more than one point on the Allergan Cheek Smoothness Scale at one month and 56% at six months.
Participants in the study reported side effects including redness, swelling, itching and discoloration, according to the company. Those reactions were usually mild or moderate, and most didn’t last longer than 30 days.
Interested providers must complete an FDA-required training program before purchasing and administering the product.
Skinvive adds to Allergan’s fold of HA products, which includes topical skincare SkinMedica and Juvederm fillers.
AbbVie joined the aesthetics fray through its massive purchase of Allergan in 2020. Last year, the company's aesthetics portfolio brought in $5.33 billion, with Botox contributing $2.6 billion and Juvederm products adding $1.42 billion.

Reference: https://www.fiercepharma.com/pharma/allergans-new-skin-smoothing-product-gets-fda-green-light-novel-delivery-mechanism