SKINVIVE™ by JUVÉDERM® Receives U.S. FDA Approval

Rhea-AI Summary

Allergan Aesthetics, an AbbVie company, has received FDA approval for SKINVIVE™ by JUVÉDERM®, the first and only hyaluronic acid intradermal microdroplet injection for improving skin smoothness of the cheeks in adults over 21. The product is a smooth, injectable HA gel that contains a small amount of local anesthetic and provides results lasting through six months with optimal treatment. It is minimally invasive, offers little to no downtime, and is approved for all Fitzpatrick Skin Types I-VI.

Positive

• SKINVIVE™ by JUVÉDERM® is the first and only hyaluronic acid intradermal microdroplet injection approved for improving skin smoothness of the cheeks in adults over 21.
• Results of SKINVIVE™ by JUVÉDERM® last through six months with optimal treatment.
• The product is minimally invasive, offers little to no downtime, and is approved for all Fitzpatrick Skin Types I-VI.

Negative

• None.

THE FIRST AND ONLY HYALURONIC ACID INTRADERMAL MICRODROPLET INJECTION, APPROVED FOR IMPROVED SKIN SMOOTHNESS OF THE CHEEKS

IRVINE, Calif., May 15, 2023 /PRNewswire/ -- Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the U.S. FDA approval of SKINVIVE™ by JUVÉDERM^® to improve skin smoothness of the cheeks in adults over the age of 21.¹ SKINVIVE™ by JUVÉDERM^® is the first and only hyaluronic acid (HA) intradermal microdroplet injection for skin smoothness available in the U.S. with results lasting through six months with optimal treatment.¹

SKINVIVE™ by JUVÉDERM^® is a smooth, injectable HA gel that contains a small amount of local anesthetic (lidocaine).¹ Unlike other facial injectables that enhance and augment the treatment area, SKINVIVE™ by JUVÉDERM^® improves skin quality in the cheeks by smoothing the skin and increasing hydration. SKINVIVE™ by JUVÉDERM^® is a specialized, smooth, hydrating gel that flows easily into the skin and is approved for all Fitzpatrick Skin Types I-VI, lightest to darkest, addressing an important unmet need in the skin quality category.³ The product was designed with global skin health experts to improve smoothness of the cheeks leading to a lasting glow.^* Treatment is minimally invasive, offers little to no downtime, and provides results over the course of six months without requiring a recurring series of treatments.^1†

"SKINVIVE™ by JUVÉDERM^® is a category-creating HA product that leaves skin looking healthier, more glowing, and more hydrated," said Carrie Strom, President, Global Allergan Aesthetics and Senior Vice President, AbbVie. "This unique product is a result of our vast experience in HA science and complements our current collection of HA products, with the JUVÉDERM^® Collection of Fillers and SkinMedica^® topicals."

"Skin quality is among the top concerns my patients express when seeking aesthetic treatments. It's an extremely important factor I consider in my therapeutic process of restoring their natural beauty and appearance," said Macrene Alexiades, M.D., Ph.D., dual U.S.-EU board-certified dermatologist, SKINVIVE™ by JUVÉDERM^® lead investigator, and author of the clinical trial published in Dermatologic Surgery. "One key way to improve skin quality is by enhancing hydration. SKINVIVE™ by JUVÉDERM^® is truly innovative because it works beneath the skin's surface to increase skin hydration improving skin quality. I am excited to add this unique offering to my dermatologic treatment regimen for my patients."

_{*Glow was reported by patients using a validated scale that included satisfaction with how radiant their skin looked.
†Optimal treatment with SKINVIVE™ by JUVÉDERM^® may require an optional touch-up one month after initial treatment to achieve the desired aesthetic outcome and is dependent on patient need.¹}

In a European post-marketing study, changes in aquaporin were observed after SKINVIVE™ by JUVÉDERM^® treatment. Aquaporin is a hydration marker that facilitates the flow of water and glycerol into and out of cells. Increases in aquaporin may signal an increase of skin hydration. Allergan Aesthetics is looking to pursue further research to better understand the significance of the changes in aquaporin observed after SKINVIVE™ by JUVÉDERM^® treatment, as demonstrated in both an ex vivo study⁴ of human skin samples and an in-situ study of the volar forearms of healthy volunteers.²

In a randomized, multicenter, evaluator-blinded, controlled pivotal clinical study, 58% (73/125) and 56% (69/124) of patients treated with SKINVIVE™ by JUVÉDERM^® saw a ≥ 1 point improvement on the Allergan Cheek Smoothness Scale (ACSS) at one month and six months respectively. In a patient reported satisfaction with skin questionnaire, 63% (78/124) of patients were satisfied with how radiant their facial skin looked at six months compared with 11% before treatment. At six months, 72% were satisfied with how hydrated their facial skin looked at six months compared to 24% before treatment. Additionally, 69% (86/124) were satisfied with how refreshed their facial skin made them look at six months compared to 16% before treatment. At month six, 83% (103/124) were satisfied with how healthy their facial skin looked compared to 38% before treatment.

The majority of subjects in the clinical study reported experiencing side effects such as redness, lumps/bumps, swelling, bruising, tenderness, pain, firmness, discoloration, and itching at the injection sites, as reported in their 30-day daily diaries. These side effects were usually mild (causing little discomfort and no effect on daily activities) or moderate (causing some discomfort and effect on daily activities) in severity, although a few participants experienced severe side effects (causing great discomfort and effect on daily activities). Investigators also reported needle abrasion and papule at the injection site. While rare, some participants experienced side effects that lasted longer than 30 days; however, most side effects went away on their own within 30 days.¹

Consumers and new patients who receive aesthetic treatment from the Allergan Aesthetics portfolio of products can also enroll in Allē, Allergan Aesthetics loyalty rewards program to unlock access to curated content, exclusive offers, and personalized rewards that can be used for savings on the Allergan Aesthetics portfolio of products and redeemed at a participating provider's office, subject to applicable program terms and conditions. Allē is the first and only loyalty program in the aesthetics market to also offer consumers the ability to earn points on over 40 non-Allergan Aesthetics treatments and brands.

As sometimes happens with novel products, the FDA has required that Allergan Aesthetics provide a training program for all interested providers. Successful completion of this training is necessary prior to purchase of and administration of SKINVIVE™ by JUVÉDERM^®.

Allergan Aesthetics anticipates that SKINVIVE™ by JUVÉDERM^® will be broadly commercially available within the next six months. To learn more about SKINVIVE™ by JUVÉDERM^® visit www.skinvivebyjuvederm.com and follow @SKINVIVEbyJUVEDERM on Instagram.

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 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: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

SKINVIVE™ by JUVÉDERM^® Injectable Gel Important Information

APPROVED USES
SKINVIVE™ by JUVÉDERM^® injectable gel is an injection to improve 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^® treatment?

Do not use this product if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), 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 specialist 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 specialist 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 specialist if you are using any medication that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners, as this may increase bruising or bleeding at the injection site
• Tell your specialist 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 specialist if you are on therapy used to decrease the body's immune response, as treatment may result in an increased risk of infection
• Tell your specialist if you are pregnant or breastfeeding. The safety for use during pregnancy, or in women who are breastfeeding, has not been studied
• Tell your specialist 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 skinvivebyjuvederm.com or talk to your specialist for more information.

SKINVIVE™ by JUVÉDERM^® is available only by a licensed physician or properly licensed practitioner.

References

1. SKINVIVE™ by JUVÉDERM^® Patient Label 2023.
2. Safa M., Natalizio A., Hee, CK. A Prospective, Open-Label Study to Evaluate the Impact of VYC-12L Injection on Skin Quality Attributes in Healthy Volunteers. Clinical, Cosmetic and Investigational Dermatology. 2022.
3. SKINVIVE™ by JUVÉDERM^® Directions for Use 2023.
4. Nakab L., Hee CK, Guetta O. Improvements in Skin Quality Biological Markers in Skin Explants Using Hyaluronic Acid Filler VYC-12L. Plastic Reconstr Surg Glob Open. 2020.

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SOURCE AbbVie

FAQ

What is the first hyaluronic acid intradermal microdroplet injection approved for improving skin smoothness of the cheeks in adults over 21?

The first hyaluronic acid intradermal microdroplet injection approved for improving skin smoothness of the cheeks in adults over 21 is SKINVIVE™ by JUVÉDERM®.

How long do the results of SKINVIVE™ by JUVÉDERM® last?

The results of SKINVIVE™ by JUVÉDERM® last through six months with optimal treatment.

Is SKINVIVE™ by JUVÉDERM® suitable for all skin types?

Yes, SKINVIVE™ by JUVÉDERM® is approved for all Fitzpatrick Skin Types I-VI.