FDA NewsPerspective

FDA approves Juvéderm Vollure XC for treating nasolabial folds with results up to 18 months

The FDA has approved marketing Juvéderm Vollure XC for correcting moderate-to-severe wrinkles and folds, such as nasolabial folds, in adults aged 21 years and older, according to a news release from Allergan.

In a clinical U.S. trial, a majority (59%) of people treated with Juvéderm Vollure XC, which is formulated with Allergan’s proprietary Vycross technology that blends different molecular weights of hyaluronic acid, had improvement of moderate-to-severe nasolabial folds up to 18 months, according to the release.

Overall, 82% of patients reporting being very satisfied at 6 months and 68% reporting being very satisfied at 18 months.

“What’s exciting about Juvéderm Vollure XC is that it was shown to last up to 18 months from the initial or touch-up injection in a majority of subjects, which is the longest lasting result shown in a clinical study in the nasolabial folds,” Joely Kaufman, MD, a board-certified dermatologist and clinical trial investigator, stated in the release. “As the number of patients seeking dermal filler treatments continues to grow, I am pleased that the technology created by Allergan has also followed that same trend, with a full range of products that will allow for tailoring of treatment based on specific patient needs.”

Juvéderm Vollure XC includes a balance of gel firmness and low cohesivity, which yields a versatile formulation that adds subtle volume for correcting moderate-to-severe facial wrinkles and folds.

The most common adverse events (AEs) in the clinical study were temporary injection site responses at the treatment site including swelling, tenderness, bruising, firmness lumps/bumps, redness, pain, discoloration, and itching, with most AEs resolving within 1 week, according to Allergan.

Juvéderm Vollure XC was approved in Europe as Juvéderm Volift in 2013, according to the release.

Allergan reports it expects Juvéderm Vollure XC to be available to physicians in April.

 

Reference: www.allergan.com

The FDA has approved marketing Juvéderm Vollure XC for correcting moderate-to-severe wrinkles and folds, such as nasolabial folds, in adults aged 21 years and older, according to a news release from Allergan.

In a clinical U.S. trial, a majority (59%) of people treated with Juvéderm Vollure XC, which is formulated with Allergan’s proprietary Vycross technology that blends different molecular weights of hyaluronic acid, had improvement of moderate-to-severe nasolabial folds up to 18 months, according to the release.

Overall, 82% of patients reporting being very satisfied at 6 months and 68% reporting being very satisfied at 18 months.

“What’s exciting about Juvéderm Vollure XC is that it was shown to last up to 18 months from the initial or touch-up injection in a majority of subjects, which is the longest lasting result shown in a clinical study in the nasolabial folds,” Joely Kaufman, MD, a board-certified dermatologist and clinical trial investigator, stated in the release. “As the number of patients seeking dermal filler treatments continues to grow, I am pleased that the technology created by Allergan has also followed that same trend, with a full range of products that will allow for tailoring of treatment based on specific patient needs.”

Juvéderm Vollure XC includes a balance of gel firmness and low cohesivity, which yields a versatile formulation that adds subtle volume for correcting moderate-to-severe facial wrinkles and folds.

The most common adverse events (AEs) in the clinical study were temporary injection site responses at the treatment site including swelling, tenderness, bruising, firmness lumps/bumps, redness, pain, discoloration, and itching, with most AEs resolving within 1 week, according to Allergan.

Juvéderm Vollure XC was approved in Europe as Juvéderm Volift in 2013, according to the release.

Allergan reports it expects Juvéderm Vollure XC to be available to physicians in April.

 

Reference: www.allergan.com

    Perspective
    Kimberly Butterwick

    Kimberly Butterwick

    I am excited that we now have another FDA approved filler, soon to be in our hands, called Juvéderm Vollure.  Introduced in Europe in 2013 where it is known as Juvéderm Volift, this filler uses the same Vycross technology as Juvéderm Voluma and Vobella and as such has similar properties of long lasting duration (up to 18 months in the NLFs) and low water affinity. It has a concentration of 17.5 mg/ml and is of medium firmness.

    Juvéderm Vollure has been described enthusiastically to me by international colleagues as giving instant steady smooth correction and soft natural projection.  It is said to be very versatile for medium to deep folds or concavities, providing a smooth coating of defects. It has even been called the “Swiss Army Knife” of fillers. 

    A postmarketing study of 70 patients treated with an average of 3 ml total for both nasolabial folds, published in the February 2017 issue of Dermatologic Surgery (Sattler et al), showed no unusual or persistent adverse events and excellent patient satisfaction, with nearly 70% still satisfied at 18 months. 

    This filler certainly sounds like a safe, natural, smooth and versatile one. I am pleased with the range of filler options we have now, but always love working with new fillers, adding to my artistic palette and ultimately being able to provide optimal results for each unique patient.

    • Kimberly Butterwick, MD
    • Dermatologist, Cosmetic Laser Dermatology, San Diego

    Disclosures: Butterwick reports serving on the advisory board for Allergan.

    Perspective
    Shannon Humphrey

    Shannon Humphrey

    Juvéderm Volift (Juvederm Vollure) has been Health Canada approved since 2014.  The availability of Juvéderm Voluma, Vollure, and Volbella in Canada really provides a full complement of advanced formulation, hyaluronic acid fillers with unique rheologic properties to allow me to achieve the best and most natural looking results for my patients.  

    Vollure specifically allows me to achieve a look that is both soft and volumizing.  The tissue integration is excellent and does not tend to cause overcorrection or lumps.  I often use Juvéderm Vollure at the oral commisure and nasolabial fold. It also has excellent utility in patients with very thin skin or limited facial volume.  Vollure offers soft contouring without looking unnatural in these patients.

    Its benefit is really in completing the rheologic profile within the Juvéderm Vycross collection, giving me a customized choice of filler for each indication.

    • Shannon Humphrey, MD, FRCPC, FAAD
    • Clinical Assistant Professor, Director of CME Department of Dermatology, UBC

    Disclosures: Humphrey reports serving as a speaker, consultant and investigator for Allergan.

    Perspective

    Excitingly, the FDA approval of Vollure increases our repertoire of dermal fillers.  While there are multiple other available options to treat moderate to severe wrinkles and folds, this product is novel because of its increased longevity for the indication of nasolabial folds.  Current hyaluronic acid fillers indicated for nasolabial folds have been shown to last up to a year, whereas Vollure may persist for 18 months. 

    Derek Jones
    Derek Jones

    Moreover, this approval expands the line of Vycross-derived fillers in the U.S., which have advantages over other technologies due to their relatively low hydrophilicity.  Vollure, just like its widely popular sister products Voluma and Vobella, binds water less avidly so bulges are less likely to occur.  

    When considering these treatments, I want to reiterate the importance of seeing a well-trained, board-certified aesthetic physician such as dermatologist or plastic surgeon for the procedure.  We look forward to introducing Vollure to our practice.

    >Amelia Hausauer, MD
    Amelia Hausauer

    Derek Jones, MD

    Associate professor of dermatology, UCLA

    Amelia Hausauer, MD

    Board-certified dermatologist, Skincare and Laser Physicians of Beverly Hills

    Disclosures: Hausauer reports serving as an investigator for Allergan. Jones reports serving as an investigator, consultant and speaker for Allergan.