Allergan Aesthetics submitted a supplemental premarket approval application (PMA) for the use of Skinvive by Juvéderm for the neck, a hyaluronic acid intradermal microdroplet injection originally approved by the FDA in 2023 for smoothness of the cheeks. The application was accepted by the FDA for review in June, and if approved, the injectable will be used for the appearance of neck lines.
Skinvive by JuvédermCourtesy Of Allergan Aesthetics
Though these regions differ in thickness and aging patterns, studies show that inventions of non-invasive and minimally invasive treatments are addressing the face and neck as unified esthetic unit, as clinicians have moved away from a treatment focus on isolated “problem areas” [1]. The potential approval of this injection further reflects the shift toward harmonizing treatments across these regions.
“While patients in my practice seem to show more concern for traditional facial aesthetic areas like the forehead and between or around the eyes, they are becoming increasingly aware of neck concerns, including fine lines and dry or dull skin,” says Jeanine Downie, MD.
If approved, Skinvive could offer a minimally invasive solution to reduce neck lines and improve neck appearance, she adds, as the modified hyaluronic acid in Skinvive is designed to improve smoothness and hydrate from within for smooth texture and a radiant glow, without changing neck shape or volume.
Per a June 30 press release, the PMA submission was supported by data from a multicenter, evaluator-blinded, randomized controlled study evaluating the safety and effectiveness of Skinvive in adults with moderate to severe horizontal neck lines. Nearly 90% of patients treated with the injectable reported improvement in neck appearance at month one, the release states.
For the FDA to approve a PMA, it requires a four-step review process, and if an application does not meet a minimum threshold of acceptability, FDA will refuse to file the application for substantive review. The four step process includes administrative and limited scientific review by FDA staff; in-depth scientific, regulatory and Quality System review by FDA personnel; review and recommendation by the appropriate advisory committee; final deliberations, documentation and notification of the FDA decision [2].
“Skinvive by Juvéderm could complement other existing neck treatment options and be used alongside external modalities such as microneedling as part of a multi-modal approach to address patient’s neck concerns,” Downie says.
References:
1-https://onlinelibrary.wiley.com/doi/full/10.1002/der2.238
2-https://www.fda.gov/medical-devices/premarket-approval-pma/pma-review-process
