Key Takeaways
First-of-its-kind indication: Skinvive by Juvederm may become the first hyaluronic acid injectable approved in the United States specifically for horizontal neck lines.
Strong clinical performance: 80% of patients saw a one-grade improvement in neck lines at one month and nearly 90% reported aesthetic improvement by the Global Aesthetic Improvement Scale.
Expands AbbVie’s aesthetics leadership: The filing supports AbbVie’s strategy to extend its facial injectables portfolio beyond the cheeks into the lower face and neck.
The FDA has accepted for review a supplemental premarket approval (sPMA) application for AbbVie subsidiary Allergan Aesthetics’ Skinvive by Juvederm for the improvement of neck appearance, specifically targeting horizontal neck lines. The submission is supported by data from a Phase III clinical trial (NCT05741034) of the therapy conducted in adults with moderate to severe neck lines.1
Could Skinvive by Juvederm Become the First Hyaluronic Acid Injectable for Neck Lines?
"Skinvive by Juvederm is an injectable version of hyaluronic acid, a naturally occurring molecule found in the skin and important for skin hydration," said Darin Messina, PhD, SVP, aesthetics R&D, AbbVie, in a press release. "The submission of Skinvive by Juvederm to treat neck lines demonstrates our continued focus on developing new indications for comprehensive lower face and neck treatment as part of our market-leading portfolio of products, including Botox Cosmetic and SkinMedica”
Trial Design and Endpoints
- The randomized, evaluator-blinded, multicenter trial evaluated the safety and efficacy of Skinvive by Juvederm for the correction of neck lines in 159 adults.
- During the trial, patients were randomly assigned to receive either Skinvive or a placebo.
- Patients in the treatment group received an initial injection at the first visit and were followed for up to 13 months, with the option of a touch-up during the follow-up period.
- Control group participants received no treatment for the first two months but were given the opportunity to receive the treatment afterward, with follow-up continuing for up to 10 months.
- The dual primary endpoints of the trial were the percentage of patients achieving responder status based on the Evaluating Investigator’s (EI) live assessment of transverse neck lines using the Allergan Transverse Neck Lines Scale and the number of patients with adverse events (AEs).
- Secondary endpoints included the percentage of participants achieving responder status on the EI’s assessment of global aesthetic improvement of the neck using the Global Aesthetic Improvement Scale (GAIS), participant-reported GAIS responses, and changes from baseline after two months in the FACE-Q Appraisal of Neck questionnaire overall score.2
Trial Results and Safety Profile
- Results showed that 80% of treated patients achieved at least a one-grade improvement in neck lines within one month, with nearly 90% reporting aesthetic improvements as assessed by GAIS.
- Patients also reported significantly reduced concern about neck appearance as measured by the FACE-Q questionnaire.
- Treatment-emergent AEs were reported to be mild and aligned with the product’s known safety profile.
- Additional clinical data are expected to be presented at upcoming scientific meetings.
Existing Indication and Safety Considerations
Allergan warns against the use of Skinvive in patients with a history of anaphylaxis, presence of severe allergies, or who are allergic to lidocaine or the Gram-positive bacterial proteins used in the formulation.1
