FDA Accepts Supplemental Premarket Approval Application for Allergan’s Skinvive by Juvederm to Treat Horizontal Neck Lines

The supplemental premarket approval application is supported by Phase III data, which showed significant improvements in neck appearance in patients treated with Skinvive.

Image Credit: Adobe Stock Images/Herseliia

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

Skinvive was first approved by the FDA in May 2023 to improve skin smoothness of the cheeks in adults over 21 years of age. The regulatory action marked the first and only hyaluronic acid intradermal microdroplet injection for skin smoothness to be available in the United States with results lasting through six months with optimal treatment, according to Allergan.³

"Patients express frustration about the visible changes in their neck due to aging and sun exposure and seek non-surgical treatment options to address them," said Jeanine Downie, MD, FAAD, board-certified dermatologist, clinical investigator, in the press release. "Skinvive by Juvederm may offer another tool for patients exploring their aesthetics treatment journey beyond the face."

References

U.S. Food and Drug Administration Accepts for Review Allergan Aesthetics Premarket Approval Application for SKINVIVE by JUVÉDERM® for the Improvement of Neck Appearance. PR Newswire. June 30, 2025, Accessed June 30, 2025. https://prnmedia.prnewswire.com/news-releases/us-food-and-drug-administration-accepts-for-review-allergan-aesthetics-premarket-approval-application-for-skinvive-by-juvederm-for-the-improvement-of-neck-appearance-302494011.html
A Study to Assess Adverse Events and Effectiveness of Injected JUVÉDERM® VOLITE™ Gel Filler for Change in Neck Lines in Adult Chinese Participants. Clinicaltrials.gov. Accessed June 30, 2025. https://clinicaltrials.gov/study/NCT05741034?rank=1
SKINVIVE™ by JUVÉDERM® Receives U.S. FDA Approval. PR Newswire. May 15, 2023. Accessed June 30, 2025. https://www.prnewswire.com/news-releases/skinvive-by-juvederm-receives-us-fda-approval-301824129.html?utm_source=chatgpt.com

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