FDA approves Skinvive to address horizontal neck wrinkles, “tech neck”

The FDA has approved Skinvive by Juvéderm (hyaluronic acid injectable gel) for reducing horizontal neck lines and improving neck appearance in adults over the age of 21. This makes Skinvive by Juvéderm the first and only hyaluronic acid injectable indicated for this anatomical area. The approval was announced on June 16 by drugmaker Allergan Aesthetics in a news release.

It is the product's second FDA-cleared indication; it has been approved since 2023 to improve skin smoothness of the cheeks.

"The approval of Skinvive by Juvéderm for horizontal neck wrinkles reflects Allergan Aesthetics' commitment to developing science-driven innovations that address meaningful unmet aesthetic needs," Darin Messina, Ph.D., senior vice president, aesthetics R&D, AbbVie, said in the news release. "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.

There are many reasons why horizontal neck wrinkles develop, including but not limited to weight loss, sun damage, and/or "tech neck” the colloquial term used to describe neck lines from repeatedly looking down at tables, phones or computers.

Skinvive is an injectable hyaluronic acid gel formulated to improve skin hydration and texture rather than provide volumetric augmentation. It is administered via ultrafine needle or cannula and contains lidocaine as a local anesthetic to support patient comfort.

The approval was supported by a randomized, multicenter, evaluator-blinded, controlled pivotal clinical study of 105 participants. The primary endpoint was clinically significant improvement, defined as a 1-point or greater gain on the validated 5-grade photonumeric Allergan Transverse Neck Lines Scale (ATNLS) at one-month post-treatment.

In the treatment group, 74.8% of participants achieved at least a 1-point improvement on the ATNLS at one month. Durability data showed that 66% of participants maintained that degree of improvement at six months, and participants who demonstrated improvement from baseline kept response rates at or above 78% at all study timepoints. The press release states that results last six months with optimal treatment, which may require an optional touch-up one month after the initial session.

Adverse events reported by participants in electronic diaries included redness, bruising, tenderness, lumps and bumps, swelling, firmness, pain, discoloration and itching at injection sites. These were generally mild, did not require treatment, and resolved within two weeks. Severe adverse events occurred in fewer than 5% of participants and were reported at similar or lower rates following touch-up and repeat treatments.

The safety and effectiveness of the neck treatment have not been studied in patients with darker skin tones, representing a meaningful gap in the generalizability of the trial data.

The prescribing information includes a warning common to all dermal filler products regarding inadvertent intravascular injection. Although the likelihood is described as very small, potential complications include vision abnormalities, blindness, stroke, skin necrosis, and permanent scarring, most of which may be irreversible. Contraindications include a history of severe allergic reactions or anaphylaxis, allergy to lidocaine or gram-positive bacterial proteins used in manufacture and prior allergic reactions to hyaluronic acid fillers.

The FDA has required Allergan Aesthetics to provide a mandatory training program for all interested providers, and successful completion is a prerequisite for purchase and administration of the product. Broad commercial availability for the neck indication is anticipated later in 2026.