FDA Accepts Allergan’s Application to Expand SKINVIVE by JUVÉDERM® for Neck Line Treatment
Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental premarket approval (sPMA) application for SKINVIVE by JUVÉDERM®, aiming to expand its approved use to include the reduction of neck lines and improvement of neck appearance in adults. This marks a significant milestone for Allergan as the company continues to build its portfolio of aesthetic treatment options beyond the face.
Currently, SKINVIVE by JUVÉDERM® is approved in the United States as the first and only hyaluronic acid (HA) microdroplet injectable designed to enhance skin smoothness in the cheeks of adults over 21. If approved for the new indication, it will become the first HA-based injectable therapy specifically targeting neck lines, providing an innovative, non-surgical solution for an area of growing aesthetic concern.
“SKINVIVE by JUVÉDERM® is an injectable version of hyaluronic acid, a naturally occurring molecule important for skin hydration,” said Darin Messina, Ph.D., Senior Vice President of Aesthetics R&D at AbbVie. “This sPMA reflects our ongoing commitment to offering comprehensive treatment options for the lower face and neck—areas that patients frequently want to address.”
Addressing a Key Aesthetic Concern
Neck lines have emerged as a prominent focus for individuals seeking professional aesthetic treatments. According to Allergan, millions are concerned with the visible effects of aging and sun exposure on their necks. However, effective, non-invasive solutions remain limited.
With this application, SKINVIVE by JUVÉDERM® could soon offer patients a first-of-its-kind injectable option to target horizontal neck lines, a common and frustrating sign of aging.
Robust Clinical Data Supports sPMA Submission
The FDA’s decision to accept the application is based on results from a multicenter, evaluator-blinded, randomized controlled trial that evaluated the safety and efficacy of SKINVIVE by JUVÉDERM® in adults with moderate to severe horizontal neck lines. The clinical study met all primary and secondary endpoints:
- 80% of patients achieved at least a one-grade improvement in neck lines by month one, based on investigator assessments.
- Nearly 90% of patients reported visible improvement in neck appearance, as measured by the Global Aesthetic Improvement Scale (GAIS).
- Patients receiving SKINVIVE reported feeling significantly less bothered by the appearance of their necks, as assessed by the FACE-Q questionnaire, while no notable changes were observed in the control group.
Treatment-emergent adverse events were generally mild and consistent with SKINVIVE’s established safety profile. Further study data will be presented at an upcoming medical conference and submitted for peer-reviewed publication.
“Many patients feel frustrated by the visible signs of aging on the neck and want non-surgical options to address them,” said Dr. Jeanine Downie, MD, FAAD, a board-certified dermatologist and study investigator. “SKINVIVE by JUVÉDERM® may offer a new tool in our treatment arsenal for patients exploring aesthetic options beyond the face.”
About SKINVIVE by JUVÉDERM® Injectable Gel
Approved Use (Current)
SKINVIVE by JUVÉDERM® is FDA-approved for intradermal injection to improve facial skin smoothness of the cheeks in adults over the age of 21.
Important Safety Information
Contraindications
Do not use SKINVIVE by JUVÉDERM® if you:
- Have severe allergic reactions or multiple severe allergies.
- Are allergic to lidocaine or the Gram-positive bacterial proteins used in the product.
- Have a history of allergic reactions to hyaluronic acid fillers.
Warnings
One rare but serious risk is inadvertent injection into a blood vessel, which could lead to complications such as:
- Vision abnormalities or blindness
- Stroke
- Permanent skin scarring
Seek immediate medical attention if you experience visual changes, difficulty speaking, severe headaches, or sudden numbness or weakness post-treatment.
Avoid use in areas with active skin issues like infections, rashes, or cysts, and postpone treatments until these conditions resolve.
The removal of dermal fillers has not been extensively studied.
Precautions
Patients should:
- Avoid alcohol, heat exposure, and strenuous exercise for 24 hours post-injection.
- Inform their doctor if taking medications that prolong bleeding (e.g., aspirin, ibuprofen).
- Discuss upcoming procedures (e.g., lasers, peels) that might interfere with results.
- Not use SKINVIVE if pregnant or breastfeeding, or if they have a history of scarring or pigmentation disorders.
Common Side Effects
Reported side effects typically resolve within 7 days and include:
- Redness, swelling, bruising
- Pain or tenderness at the injection site
- Itching, firmness, or discoloration
Less common events include:
- Inflammation, allergic reactions
- Nodules or abscesses
- Blood vessel blockage
Patients are encouraged to report adverse events to Allergan’s Product Support at 1-877-345-5372.
Related Products: BOTOX® Cosmetic
As part of its broader aesthetics portfolio, Allergan also markets BOTOX® Cosmetic (onabotulinumtoxinA) for the temporary improvement of moderate to severe facial lines and platysma bands.
Key Safety Warning for BOTOX®
BOTOX® Cosmetic carries a boxed warning for the distant spread of toxin effects, which in rare cases can cause life-threatening breathing or swallowing difficulties. Although such events are rare and mostly observed in non-aesthetic uses or vulnerable populations, patients should be aware of symptoms like generalized weakness, difficulty speaking, or trouble breathing.
Other side effects may include:
- Eyelid drooping (ptosis)
- Facial weakness
- Dry eye
- Headache or discomfort at injection sites
Serious cardiovascular and hypersensitivity reactions have been reported in rare cases
