FDA Approves SKINVIVE by JUVÉDERM as First Hyaluronic Acid Injectable for Horizontal Neck Lines
核心洞察
The FDA approved SKINVIVE by JUVÉDERM (搜索) for reducing horizontal neck lines and improving neck appearance in adults over 21, making it the first and only HA injectable indicated for this use.
In a pivotal trial, 74.8% of participants achieved clinically significant improvement on the Allergan Transverse Neck Lines Scale at one month, with 66% maintaining improvement at six months.
The product addresses "tech-neck" wrinkles caused by prolonged head-down positioning with devices, as well as aging and sun damage, with a minimally invasive administration and little to no downtime.
Allergan Aesthetics (搜索), an AbbVie (搜索) company, announced on June 16, 2026 that the U.S. Food and Drug Administration has approved SKINVIVE by JUVÉDERM (搜索) to reduce neck lines for the improvement of neck appearance in adults over the age of 21. This marks the first and only hyaluronic acid injectable indicated to reduce the appearance of neck wrinkles and help skin retain its natural moisture, establishing a new category in the aesthetic injectables market.
The approval represents the second FDA-cleared indication for SKINVIVE by JUVÉDERM (搜索), which has been approved since 2023 to improve skin smoothness of the cheeks in adults. The new indication specifically targets horizontal neck lines, which may develop due to natural aging, sun damage, weight loss, or "tech-neck" — a phenomenon caused by the head-down position used for phones, tablets, and books.
"The approval of SKINVIVE by JUVÉDERM (搜索) for horizontal neck wrinkles reflects Allergan Aesthetics (搜索)' commitment to developing science-driven innovations that address meaningful unmet aesthetic needs," said Darin Messina, Ph.D., senior vice president, aesthetics R&D, AbbVie (搜索). "This approval expands our portfolio of lower face and neck treatment options and gives patients and aesthetic providers a first-of-its-kind treatment option for improving neck skin quality and reducing the appearance of neck lines."
Clinical Evidence from the Pivotal Trial
The approval was supported by a randomized, multicenter, evaluator-blinded, controlled pivotal clinical study. At one month post-treatment, 74.8% (78.5/105) of participants treated in the neck with SKINVIVE by JUVÉDERM (搜索) demonstrated clinically significant improvement, defined as at least a one-point improvement on the validated 5-grade photonumeric Allergan Transverse Neck Lines Scale (ATNLS). Durability data showed that most participants — 66% (64/97) — maintained at least a one-point improvement in horizontal neck lines at six months. Among participants who demonstrated improvement from baseline in overall score, the response rate remained high, at or above 78%, across all timepoints during the study.
The safety and effectiveness of SKINVIVE by JUVÉDERM (搜索) neck treatment has not been studied in darker skin tone patients, a limitation noted in the product labeling.
Safety Profile and Administration
The treatment is minimally invasive with little to no downtime and is administered using an ultrafine needle or cannula. The product contains a small amount of local anesthetic (lidocaine) to support patient comfort during treatment. Results last six months with optimal treatment, which may require an optional touch-up one month after initial treatment depending on patient need.
Participants in the clinical study reported adverse events including redness, bruising, tenderness, lumps/bumps, swelling, firmness, pain, discoloration, and itching at the injection sites. These adverse events were usually mild, causing little discomfort and no effect on daily activities, did not require treatment, and resolved within two weeks. Severe adverse events were experienced by less than 5% of participants (7/147 reporting AEs). These events were reported similarly or less frequently after touch-ups and repeat treatments.
Provider Training and Market Availability
The FDA has required that Allergan Aesthetics (搜索) provide a training program for all interested providers. Successful completion of this training is necessary prior to purchase and administration of SKINVIVE by JUVÉDERM (搜索). Allergan Aesthetics anticipates that SKINVIVE by JUVÉDERM for the improvement of neck appearance will be broadly commercially available later this year.
SKINVIVE by JUVÉDERM (搜索) is available only by a licensed physician or properly licensed practitioner. Contraindications include a history of multiple severe allergies or anaphylaxis, allergy to lidocaine or Gram-positive bacterial proteins used in the product, or previous allergic reactions to hyaluronic acid fillers.