DUBLIN, Sept. 3, 2019 /PRNewswire/ -- Allergan plc (NYSE: AGN) announced today it received U.S. Food and Drug Administration (FDA) approval for the use of Juvéderm VOLUMA® XC, a hyaluronic acid gel dermal filler, with a TSK STERiGLIDE™ cannula for cheek augmentation to correct age-related volume deficit in the mid-face in adults over 21. A cannula is a thin, flexible tube with a rounded tip that can serve as an effective delivery system. Use of a cannula allows for injection of Juvéderm VOLUMA® XC in the cheek area. The TSK STERiGLIDE™ has a unique design compared to other cannulas available on the market and features a patented tip design with a near-tip delivery port for precise product placement.
"As a physician, I have used the Juvéderm Collection of Fillers for 13 years, so I am thrilled that the FDA has approved the use of cannula with Juvéderm VOLUMA® XC for mid-face volume deficit. With this latest approval, I have another effective option to provide volume and contour in the mid-face area. I can tailor my treatment approach for each patient while safely providing the aesthetic outcomes they wish to achieve," says Dr. Dee Anna Glaser, a board-certified dermatologist in St. Louis and clinical trial investigator.
"At Allergan, we are committed to driving innovation in medical aesthetics as well as providing best-in-class injector training to our customers," says Carrie Strom, Senior Vice President of U.S. Allergan Medical Aesthetics. "With this approval, Allergan will be able to educate on facial anatomy and injection techniques that will help healthcare providers administer treatment with Juvéderm VOLUMA® XC safely to achieve optimal patient satisfaction."
A multicenter, split-face, investigator-blinded, non-inferiority study was performed to assess the safety and effectiveness of Juvéderm VOLUMA® XC for correction of age-related volume deficit in the mid-face with the use of a TSK STERiGLIDE™ cannula versus a needle. The 12-week study took place in seven sites across the U.S. with 60 subjects. All subjects completed the study. Results demonstrated comparable performance, safety profile and patient satisfaction between cannula and needle injection.
Within the Juvéderm Collection of Fillers, this is the first approval for the use of cannula. Juvéderm VOLUMA® XC was first approved by the FDA in 2013 and is formulated with Allergan's proprietary VYCROSS® technology, which blends different molecular weights of hyaluronic acid, contributing to the gel's duration and is proven to last in the mid-face area for up to 24 months with optimal treatment. Juvéderm VOLUMA® XC is currently the best-selling Juvéderm product in the US.
For more information about the Juvéderm® Collection of Fillers please visit www.juvederm.com.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology. As part of its approach to delivering innovation for better patient care, Allergan has built one of the broadest pharmaceutical and device research and development pipelines in the industry.
With colleagues and commercial operations located in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS®, on our financial results; risks associated with divestitures, acquisitions, mergers and joint ventures; risks related to impairments; uncertainty associated with financial projections, projected cost reductions, projected debt reduction, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2018 and Allergan's Quarterly Report on Form 10-Q for the period ended June 30, 2019. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
Important Safety Information about JuvédermVOLUMA® XC
INDICATION JUVÉDERM VOLUMA® XC injectable gel is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS This product should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to gram-positive bacterial proteins or lidocaine contained in this product.
Do not inject into blood vessels. Introduction of this product into the vasculature may lead to embolization, occlusion of the vessels, ischemia or infarction. Take extra care when injecting soft-tissue fillers; for example, inject the product slowly and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled
In order to minimize the risk of potential complications, this product should only be used by healthcare professionals who have appropriate training, experience, and knowledge of facial anatomy
Healthcare professionals are encouraged to discuss the potential risks of soft-tissue injections with their patients prior to treatment and ensure that patients are aware of signs and symptoms of potential complications
The safety and effectiveness for the treatment of anatomic regions other than the mid-face have not been established in controlled clinical studies
The safety for use during pregnancy and in breastfeeding females has not been established
The safety for use in patients under 35 or over 65 years has not been established
As with all transcutaneous procedures, dermal filler implantation carries a risk of infection. Follow standard precautions associated with injectable materials
The safety for use in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied
Use with caution in patients on immunosuppressive therapy
Patients who are using products that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
Patients who experience skin injury near the site of implantation may be at a higher risk for adverse events
The safety for use in patients with very thin skin in the mid-face has not been established
Patients may experience late onset nodules with use of dermal fillers including JUVÉDERM VOLUMA® XC
ADVERSE EVENTS Side effects in > 5% of subjects were temporary injection-site tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. They were predominantly moderate in severity, with a duration of 2 to 4 weeks.
To report an adverse reaction, please call Allergan Product Surveillance at 1-877-345-5372.
For more information, please see JuvedermDFU.com or call the Allergan Medical Information line at 1-800-433-8871.
JUVÉDERM VOLUMA® XC injectable gel is available by prescription only.