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Classified in: Health, Science and technology
Subject: FDA

Allergan Receives FDA Approval of Juvéderm VOLUMA® XC For Mid-Face Injection Via Cannula


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 STERiGLIDEtm 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 STERiGLIDEtm 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.

Allergan plc logo

"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 STERiGLIDEtm 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.

For more information, visit Allergan's website at www.Allergan.com.

Forward-Looking Statement

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 Juvéderm VOLUMA® 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.  

WARNINGS

PRECAUTIONS

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.

CONTACTS:  

Allergan


Investors:


Manisha Narasimhan, PhD


(862) 261-7162




Christine Chiou


(862) 261-7396




Media:


Lisa Brown


(862) 261-7320




Ember Garrett


(714) 246-3525

 

SOURCE Allergan plc


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News published on 3 september 2019 at 07:30 and distributed by: