Allergan's (AGN) JUVEDERM VOLLURE XC Gains U.S. FDA Approval for Correction of Severe Facial Wrinkles & Folds
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Allergan plc, (NYSE: AGN) today announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market JUVÉDERM VOLLURE™ XC, for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults over the age of 21.1 In the US pivotal clinical trial, a majority (59%) of subjects saw improvement in moderate to severe nasolabial folds for up to 18 months.* Patient satisfaction in the pivotal study was also high: 82% of patients said they were very satisfied at 6 months and 68% at 18 months.2
"The FDA approval of JUVÉDERM VOLLURE™ XC demonstrates Allergan's imperative to develop next-generation HA fillers designed to meet different patient needs," said David Nicholson, Chief Research and Development Officer at Allergan. "This commitment to ongoing scientific research and development is one of the factors that make JUVÉDERM®, the number one selling collection of dermal filler products."3
JUVÉDERM VOLLURE™ XC is formulated with Allergan's proprietary VYCROSS® technology, which blends different molecular weights of hyaluronic acid, contributing to the gel's duration.4† Our first product featuring VYCROSS® technology, JUVÉDERM VOLUMA® XC, was FDA-approved to increase volume lost due to aging in the cheek area,5 followed by JUVÉDERM VOLBELLA® XC, FDA-approved for lip augmentation and correction of perioral rhytids.6
Now with JUVÉDERM VOLLURE™ XC, the advanced VYCROSS® technology yields a custom engineered injectable gel product which was studied in the nasolabial folds, the number one dermal treatment area. It delivers a long-lasting result, up to 18 months*, that patients appreciate.2,4,7
JUVÉDERM VOLLURE XC™ is specifically tailored with a balance of gel firmness and low cohesivity, yielding a versatile formulation that adds subtle volume for the correction of moderate to severe facial wrinkles and folds.2,4 "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,"2 said Dr. Joely Kaufman, a board-certified dermatologist and clinical trial investigator. "As the number of patients seeking dermal filler treatments continues to grow,7 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."
The most common side effects seen in the clinical study were temporary injection site responses at the treatment site such as swelling, tenderness, bruising, firmness lumps/bumps, redness, pain, discoloration, and itching. Most of these side effects resolved within 1 week.2
JUVÉDERM VOLLURE™ XC was first approved in Europe as JUVÉDERM VOLIFT® in 2013. The JUVÉDERM® family of products is marketed and sold in more than 80 countries outside the United States.
JUVÉDERM VOLLURE™ XC will be available to physicians in April 2017. For more information about JUVÉDERM VOLLURE™ XC and the JUVÉDERM® Collection of fillers or to find a doctor, please visit www.juvederm.com.
JUVÉDERM VOLLURE™ XC Important Information
APPROVED USESJUVÉDERM VOLLURE™ XC injectable gel is for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive JUVÉDERM VOLLURE™ XC injectable gel?Do not use this product if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), or if you are allergic to lidocaine or the Gram-positive bacterial proteins used in this product.
What precautions should my doctor advise me about?
- Tell your doctor if you are pregnant or breastfeeding. The safety of this product for use during pregnancy or while breastfeeding has not been studied
- The safety of JUVÉDERM VOLLURE™ XC in patients under 22 years has not been studied
- The safety and effectiveness of JUVÉDERM VOLLURE™ XC in areas other than facial wrinkles and folds have not been established in clinical studies
- Tell your doctor if you have a history of excessive scarring (e.g., hypertrophic scarring and keloid formations) or pigmentation disorders, as use of this product may result in additional scars or changes in pigmentation
- Tell your doctor if you are planning other laser treatments or a chemical peel, as there is a possible risk of inflammation at the treatment site if these procedures are performed after treatment
- Patients who experience skin injury near the site of injection with this product may be at a higher risk for side effects
- Tell your doctor if you are on immunosuppressive therapy used to decrease the body's immune response, as use of this product may result in an increased risk of infection
- Tell your doctor if you are using medications that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners, as this may result in increased bruising or bleeding at the injection site
- Minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment
What are possible side effects?The most commonly reported side effects with JUVÉDERM VOLLURE™ XC injectable gel included injection-site redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. Most side effects were mild or moderate and lasted 7 days or less.
One of the risks with using this product is unintentional injection into a blood vessel, and, while rare, 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.
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