AbbVie: U.S. Food and Drug Administration Accepts for Review Allergan Aesthetics Premarket Approval Application for SKINVIVE by JUVÉDERM for the Improvement of Neck Appearance

• SKINVIVE by JUVÉDERM® is currently approved in the U.S. as the first and only hyaluronic acid microdroplet injectable indicated to improve cheek skin smoothness.
• If approved, SKINVIVE by JUVÉDERM® will be the first hyaluronic acid injectable treatment option aiming to reduce neck lines.
• The application for indication expansion is supported by a clinical study that met all primary and secondary endpoints assessing SKINVIVE by JUVÉDERM® in adults with neck lines seeking improvement in neck appearance.¹

IRVINE, Calif., June 30, 2025 /PRNewswire/ -- Allergan Aesthetics, an AbbVie company (NYSE: ABBV), today announced that the U.S. Food and Drug Administration (FDA) accepted for review the supplemental premarket approval (sPMA) application for SKINVIVE by JUVÉDERM® to reduce neck lines for the improvement of neck appearance. SKINVIVE by JUVÉDERM® is currently approved in the U.S. to improve skin smoothness of the cheeks in adults over the age of 21.

"SKINVIVE by JUVÉDERM® is an injectable version of hyaluronic acid, a naturally occurring molecule found in the skin and important for skin hydration," said Darin Messina, Ph.D., senior vice president, aesthetics R&D, AbbVie. "The submission of SKINVIVE by JUVÉDERM® 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®."

Neck appearance is a top concern among people seeking aesthetic treatment, with millions of consumers considering professionally administered treatments to address their neck concerns.² SKINVIVE by JUVÉDERM® could offer the first hyaluronic acid injectable that aims to reduce neck lines to improve neck appearance.

The sPMA submission is supported by data from a multicenter, evaluator-blinded, randomized controlled study evaluating the safety and effectiveness of SKINVIVE by JUVÉDERM® in adults with moderate to severe horizontal neck lines seeking improvement in neck appearance.¹ All primary and secondary endpoints were met.¹ Based on investigator assessment of horizontal neck lines, 80% of patients treated with SKINVIVE by JUVÉDERM® achieved at least a 1-grade improvement at month 1.^1,3 Nearly 90% of patients treated with SKINVIVE by JUVÉDERM® reported improvement in neck appearance at month 1 as assessed by the Global Aesthetic Improvement Scale.¹ Patients treated with SKINVIVE by JUVÉDERM® reported being significantly less bothered with the overall appearance of their neck following treatment as measured by the FACE-Q questionnaire, while patients in the control group demonstrated no significant change.¹ Treatment-emergent adverse events for SKINVIVE by JUVÉDERM® were mild in severity and consistent with known safety profile.¹ Additional data from the clinical study will be submitted for presentation at a future medical congress and for publication.

"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 and clinical investigator. "SKINVIVE by JUVÉDERM® may offer another tool for patients exploring their aesthetics treatment journey beyond the face."

SKINVIVE by JUVÉDERM® Injectable Gel Important Information

APPROVED USES
SKINVIVE by JUVÉDERM® Injectable Gel is an intradermal injection to improve facial skin smoothness of the cheeks in adults over the age of 21.

IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive SKINVIVE by JUVÉDERM® injectable gel treatment?
Do not use this product if you have a history of severe reactions (anaphylaxis) or history or presence of multiple severe allergies or if you are allergic to lidocaine or the Gram-positive bacterial proteins used in this product, or if you have had previous allergic reactions to hyaluronic acid fillers.

What warnings should my doctor advise me about?

• One of the risks with dermal filler injection is the unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. Most of these events are irreversible. Tell your specialist immediately if you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment
• The use of this product where skin sores, pimples, rashes, hives, cysts, or infections are present should be postponed, as this may delay healing or make skin problems worse
• The effectiveness of removal of any dermal filler has not been studied

What precautions should my doctor advise me about?

• Minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment. Exposure to any of these may cause temporary redness, swelling, and/or itching at the injection site
• Tell your doctor if you are using any medication that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners. As with any injection, this may increase bruising or bleeding at the injection site
• Tell your doctor if you are planning laser treatment, chemical peeling, or any other procedure after SKINVIVE by JUVÉDERM®. There is a possible risk of an inflammatory reaction at the treatment site
• This product is intended for improving skin smoothness of the cheeks. The safety and effectiveness for treatment in other areas of the body have not been established
• Tell your doctor if you are on therapy used to decrease the body's immune response. Use may result in an increased risk of infection
• Tell your doctor if you are pregnant or breastfeeding. The safety for use during pregnancy, or in women who are breastfeeding, has not been studied
• Tell your doctor if you have a history of excessive scarring (thick, hard scars). The safety of this product in patients with a history of excessive scarring has not been studied and may result in additional scars
• Tell your specialist if you have a history of pigmentation disorders, as use of this product in patients with a history of pigmentation disorders has not been studied and may result in changes in pigmentation

What are the possible side effects of treatment?
The most commonly reported side effects were redness, lumps/bumps, swelling, bruising, pain, tenderness, firmness, discoloration and itching. Most side effects will resolve within 7 days. If they persist longer, your physician may choose to treat them with medications, such as antibiotics, steroids, or hyaluronidase. Additionally, there have been reports of inflammation, nodules, unsatisfactory result, loss or lack of improvement, allergic reaction, anxiety, blood vessel blockage, infection, dry skin, increase or decrease in sensation, and abscess.

Delayed-onset inflammation near the site of dermal filler injections is one of the known adverse events associated with dermal fillers. As with all skin injection procedures, there is a risk of infection.

To report a side effect, please call the Allergan® Product Support Department at 1-877-345-5372. Please also visit SKINVIVE.com or talk to your doctor for more information.
SKINVIVE by JUVÉDERM® is available only by a licensed physician or properly licensed practitioner.

BOTOX^® Cosmetic (onabotulinumtoxinA) Important Information

Indications
BOTOX^® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:
- Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
- Moderate to severe lateral canthal lines associated with orbicularis oculi activity
- Moderate to severe forehead lines associated with frontalis activity
- Moderate to severe platysma bands associated with platysma muscle activity

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

WARNING: DISTANT SPREAD OF TOXIN EFFECT

Postmarketing reports indicate that the effects of BOTOX ^® Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses and approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses.

CONTRAINDICATIONS
BOTOX^® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.

WARNINGS AND PRECAUTIONS
Lack of Equivalency Between Botulinum Toxin Products
The potency Units of BOTOX^® Cosmetic are specific to the preparation and assay method utilized. BOTOX^® Cosmetic is not equivalent to other preparations of botulinum toxin products, and therefore, Units of biological activity of BOTOX^® Cosmetic cannot be compared to nor converted into Units of any other botulinum toxin products assessed with any other specific assay method.

Spread of Toxin Effect
Please refer to Boxed Warning for Distant Spread of Toxin Effect.
No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX^® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead lines) have been reported. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech, or respiratory disorders occur.

Serious Adverse Reactions With Unapproved Use
Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX^® injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX^® to the site of injection and/or adjacent structures. In several of the cases, patients had preexisting dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of BOTOX^®. The safety and effectiveness of BOTOX^® for unapproved uses have not been established.

Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such a reaction occurs, discontinue further injection of BOTOX Cosmetic and immediately institute appropriate medical therapy. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined.

Cardiovascular System
There have been reports following administration of BOTOX^® of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors, including preexisting cardiovascular disease. Use caution when administering to patients with preexisting cardiovascular disease.

Increased Risk of Clinically Significant Effects With Preexisting Neuromuscular Disorders
Patients with neuromuscular disorders may be at increased risk of clinically significant effects, including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from onabotulinumtoxinA (see Warnings and Precautions). Monitor individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) when given botulinum toxin.

Dysphagia and Breathing Difficulties
Treatment with BOTOX^® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with preexisting swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning).

Preexisting Conditions at the Injection Site
Use caution when BOTOX^® Cosmetic treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).

Dry Eye in Patients Treated With BOTOX^® Cosmetic
There have been reports of dry eye associated with BOTOX^® Cosmetic injection in or near the orbicularis oculi muscle. If symptoms of dry eye (eg, eye irritation, photophobia, or visual changes) persist, consider referring patients to an ophthalmologist.

Human Albumin and Transmission of Viral Diseases
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries a remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), which would also be considered remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.

ADVERSE REACTIONS
The most frequently reported adverse reactions following injection of BOTOX^® Cosmetic for glabellar lines were eyelid ptosis (3%), facial pain (1%), facial paresis (1%), and muscular weakness (1%).

The most frequently reported adverse reaction following injection of BOTOX^® Cosmetic for lateral canthal lines was eyelid edema (1%).

The most frequently reported adverse reactions following injection of BOTOX^® Cosmetic for forehead lines with glabellar lines were headache (9%), brow ptosis (2%), and eyelid ptosis (2%).

The safety profile of BOTOX^® Cosmetic treatment of platysma bands is consistent with the known safety profile of BOTOX^® Cosmetic for other indications.

DRUG INTERACTIONS
Coadministration of BOTOX^® Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX^® Cosmetic may potentiate systemic anticholinergic effects.

The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.

Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX^® Cosmetic.

USE IN SPECIFIC POPULATIONS
There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX^® Cosmetic in pregnant women. There are no data on the presence of BOTOX^® Cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production.

For more information on BOTOX^® Cosmetic, please see accompanying full Prescribing Information, including Boxed Warning and Medication Guide.

US-FA-01754 10/24

About Allergan Aesthetics

At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.allerganaesthetics.com

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter) and YouTube.

Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

Media: Toni Haubert [email protected]

Investors: Liz Shea [email protected]

References

1. Data on File. ABVRRTI81230. Allergan Aesthetics, an AbbVie company.
2. Data on File. REF-138623. Allergan Aesthetics, an AbbVie company.
3. Jones et al. Dermatol Surg. 2016 Sep 26;42(Suppl 1): S235-S242

SOURCE AbbVie