-- Allergan enters skin quality category with new injectable product using VYCROSS® technology1 for use on the face, neck, décolletage and hands2
-- Hyaluronic Acid (HA) gel designed to improve skin’s smoothness (absence of fine lines), hydration and elasticity for up to nine months with just one treatment3
-- Global research shows more than half of women say appearance of skin contributes to their outer beauty4
DUBLIN, IRELAND – 27 January, 2017 – Allergan plc (NYSE: AGN), a leading global pharmaceutical company, announced today its entry into the skin quality category with the launch of Juvéderm® VOLITE.2 This is Allergan’s first injectable product specifically designed to improve skin quality5 and last up to nine months with just one treatment session.3 This innovative new Allergan product uses the unique patented VYCROSS® technology.1
A new innovation for skin quality
The new HA injectable treatment delivers improvements in skin smoothness (absence of fine lines), hydration and elasticity,2
and is designed to last for up to nine months with just one treatment.3
Clinical data so far has shown significant improvements in skin quality for up to 6 months, and the clinical study is ongoing.6,7
VOLITE aims to deliver results that last and eliminate the need for multiple treatments.3
It should be injected intradermally and can be used to treat the face, neck, décolletage and hands and contains the anaesthetic lidocaine, to enhance patient comfort.2
Dr Patricia Ogilvie, Leading Dermatologist, Germany, says: “Juvéderm®
VOLITE answers a real need for a treatment that delivers a healthy-looking glow. Combined with the fact that only one treatment is needed to achieve results, this product will be a game changer in my clinic. I believe that great skin can have a profound impact on patients’ everyday lives – in particular their confidence. It goes far beyond aesthetics - when a patient is happy with how they look on the outside, this affects how they feel on the inside. Juvéderm®
VOLITE is a genuinely innovative treatment option that I’m excited to be able to offer my patients.”
Demonstrated efficacy with Juvéderm® VOLITE
VOLITE delivers improvements on a range of skin quality5
components including smoothness (absence of fine lines), hydration and elasticity.6,7
In a clinical trial of 131 patients, the clinical study showed an improvement in skin quality at one, four and six months.6,7
One month after treatment, 96% of patients’ cheeks were smoother (investigator assessment)8
and 91% of patients reported they were more satisfied with their skin.9
Results were sustained at six months, where patients reported that they continued to see significant improvements in skin hydration and were satisfied with their skin.7,10
The final study results will be available in March 2017.
As with other medical aesthetic treatments, patients reported adverse events including bruising and pain at the injection site.8
VOLITE was well tolerated and demonstrated an acceptable safety profile, and 95% of patients were able to return to social engagements one day after treatment.8
Caroline Van Hove, Senior Vice President, International Strategic Marketing for Medical Aesthetics at Allergan says: “The launch of Juvéderm®
VOLITE defines Allergan’s disruptive entrance into the skin quality category - an area that we know is set to experience huge growth over the next few years, and with a product designed to last up to nine months with just one treatment. As a market leader, this demonstrates our ongoing commitment to delivering medical aesthetics treatments that physicians and their patients really want, that is convenient for patients and doctors, and of high quality in its results and safety.”
Allergan is strongly committed to the health, safety and well-being of the practitioners and patients who put their trust in their products. As part of the Company’s ongoing commitment to medical education, Allergan is now offering training programs for appropriate healthcare professionals on the safe and effective use of this new treatment to ensure optimal patient satisfaction and outcomes. Juvéderm®
VOLITE is currently available in Europe and various countries throughout the world. Allergan will continue to work with international regulatory authorities to make this product more widely available to aesthetic practitioners and patients throughout the world.
Allergan 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 of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. 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; 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, 2015 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2016 (certain of such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
1 VYCROSS® Patent WO20040192222A2. 2004.
2 Juvéderm® VOLITE Directions For Use 73140JR10. November 2016.
3 Allergan Data On File INT/0912/2016. December 2016.
4 Allergan Data On File INT/0393/2016. Global Beauty Report. March 2016.
5 Allergan Data On File INT/0448/2016 (1). Skin Quality Insights. July 2016.
6 Allergan Data On File INT/0652/2016. September 2016
7 Allergan Data On File INT/0654/2016. September 2016.
8 Allergan Data On File INT/0444/2016 (2). July 2016.
9 Allergan Data On File INT/0513/2016. August 2016.
10 Allergan Data On File INT/0655/2016. September 2016.