FDA Approves 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 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. Louisand 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, Allerganwill 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.
For more information, visit Allergan's website at www.Allergan.com.
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'sbusiness. 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.
SOURCE Allergan plc
Posted: September 2019
- FDA Approves Juvéderm Vollure XC for Correction of Facial Wrinkles and Folds in Adults - March 20, 2017
- FDA Approves Juvéderm Volbella XC for Use in Lips and Perioral Rhytids - June 1, 2016
- FDA Approves Juvéderm Ultra XC for Lip Augmentation - October 1, 2015
- FDA Approves Juvéderm Voluma XC to Correct Age-Related Volume Loss in the Cheek Area - October 23, 2013
- FDA Approves Juvéderm XC Containing Lidocaine to Correct Facial Wrinkles and Folds - February 1, 2010
- Juvederm Allergan, Inc. - Treatment for Facial Wrinkles and Folds - June 5, 2006
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