News Feed Item

Allergan's BOTOX® (botulinum toxin type A) Receives National Marketing Authorisation for Treatment of Moderate to Severe Crow's Feet Lines in Adult Patients

MARLOW, England, January 9, 2014 /PRNewswire/ --

New aesthetic indication for market-leading neuromodulator which can now help improve appearance of lines around the eyes, as well as treating glabellar frown lines

Today, Allergan, Inc. announced that BOTOX® has received the licence from the Medicines and Healthcare products Regulatory Agency (MHRA) for the temporary improvement in the appearance of moderate to severe lateral canthal lines (crow's feet lines) seen at maximum smile, either alone or when treated at the same time as glabellar (or frown) lines seen at maximum frown, in adult patients where these facial lines have an important psychological impact. This marketing authorisation is specific to Allergan's botulinum toxin type A product and is based on Allergan's successful global Phase III clinical trial programme in Crow's Feet Lines.

"This latest approval for BOTOX® demonstrates Allergan's continued commitment to excellence in neuromodulator innovation and our long-term leadership in medical aesthetics," said Paul Navarre, President of Allergan Europe, Africa & Middle East. "We are proud to deliver this important innovation to medical aesthetics practitioners in the UK, allowing them for the first time to treat the glabellar and crow's feet areas either alone or simultaneously."

The MHRA licence for the use of BOTOX® to treat crow's feet lines is based on the results of two randomised, multi-centre, placebo-controlled clinical studies involving more than 1,350 patients.[1] These studies met their primary endpoint, demonstrating that patients who received treatment with BOTOX® achieved none or mild lines according to investigator assessment at day 30, compared to those patients who did not receive botulinum toxin type A treatment and this significant reduction in the appearance of crow's feet lines lasted an average of four months post-treatment.[1] In general, patients treated with BOTOX® reported that they looked younger and more attractive.[1] In these studies, Allergan's botulinum toxin type A product was generally well tolerated.[1] Like all medicines, Allergan's botulinum toxin type A product may cause side effects, although the incidence rate is variable. In general, adverse reactions occurred within the first few days following injection and were temporary.[1]

"Crow's Feet Lines are amongst the top ageing concerns for people in the UK and Europe. Whilst these lines form a natural part of our eye expressions, over time they can become fixed or elongated even when our faces are relaxed, which can make us look tired or stressed," said David Eccleston, Clinical Director, MediZen Clinic. "Softening the appearance of Crow's Feet Lines as well as the glabellar lines with BOTOX® can deliver a refreshed and natural look, helping patients to look like themselves again and improve their self-confidence."

Notes to Editor

About BOTOX®

BOTOX® (botulinum toxin type A) is a prescription medication that works by relaxing the specific muscles that cause crow's feet lines or frown lines to form. By decreasing muscle activity, it's possible to soften the appearance of these lines and wrinkles without radically changing facial appearance or making a patient look as if they have had "work done". The temporary effect lasts for up to four months.[1] Patient satisfaction data shows that following treatment with BOTOX®, patients reported looking more relaxed and confident, as well as looking as young as they feel.[2] BOTOX® should only be administered in a clinical setting by an appropriately trained physician.

About Allergan's botulinum toxin type A

Worldwide, approximately 35 million vials of Allergan's botulinum toxin type A products have been distributed over the past 21 years (1990-2012). The safety and efficacy of Allergan's botulinum toxin type A product has been well-established with approximately 65 randomised, placebo-controlled clinical trials involving approximately 15,000 patients and, with more than 2,500 articles in scientific and medical journals, Allergan's neurotoxin is one of the most widely researched medicines in the world.[3]

About Allergan

Allergan is a multi‐specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life's potential. Today, we have approximately 11,100 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever‐evolving portfolio of pharmaceuticals, biologics, medical devices and over‐the‐counter consumer products, and state‐of‐the‐art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention and urologics, Allergan is proud to celebrate more than 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work.

Forward‐Looking Statement

This press release contains "forward‐looking statements", including but not limited to the statements by Mr Paul Navarre and Mr David Eccleston and other statements regarding the use of BOTOX® to treat Crow's Feet Lines. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialise, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new pharmaceutical products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations.  Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required to do so by law. Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2012 Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q.  

© Allergan, Ltd. BOTOX® is a registered trademark owned by Allergan Inc.


1. UK SmPC for BOTOX® 50 Units

2. Stotland MA et al. J Plas Recons Surg: 2007; 120(5):1386-1393

3. Allergan Data On File

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
SYS-CON Events announced today that eCube Systems, the leading provider of modern development tools and best practices for Continuous Integration on OpenVMS, will exhibit at SYS-CON's @DevOpsSummit at Cloud Expo New York, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. eCube Systems offers a family of middleware products and development tools that maximize return on technology investment by leveraging existing technical equity to meet evolving business needs. ...
Web Real-Time Communication APIs have quickly revolutionized what browsers are capable of. In addition to video and audio streams, we can now bi-directionally send arbitrary data over WebRTC's PeerConnection Data Channels. With the advent of Progressive Web Apps and new hardware APIs such as WebBluetooh and WebUSB, we can finally enable users to stitch together the Internet of Things directly from their browsers while communicating privately and securely in a decentralized way.
Amazon has gradually rolled out parts of its IoT offerings, but these are just the tip of the iceberg. In addition to optimizing their backend AWS offerings, Amazon is laying the ground work to be a major force in IoT - especially in the connected home and office. In his session at @ThingsExpo, Chris Kocher, founder and managing director of Grey Heron, explained how Amazon is extending its reach to become a major force in IoT by building on its dominant cloud IoT platform, its Dash Button strat...
Without lifecycle traceability and visibility across the tool chain, stakeholders from Planning-to-Ops have limited insight and answers to who, what, when, why and how across the DevOps lifecycle. This impacts the ability to deliver high quality software at the needed velocity to drive positive business outcomes. In his general session at @DevOpsSummit at 19th Cloud Expo, Eric Robertson, General Manager at CollabNet, will discuss how customers are able to achieve a level of transparency that e...
Two weeks ago (November 3-5), I attended the Cloud Expo Silicon Valley as a speaker, where I presented on the security and privacy due diligence requirements for cloud solutions. Cloud security is a topical issue for every CIO, CISO, and technology buyer. Decision-makers are always looking for insights on how to mitigate the security risks of implementing and using cloud solutions. Based on the presentation topics covered at the conference, as well as the general discussions heard between sessi...
For basic one-to-one voice or video calling solutions, WebRTC has proven to be a very powerful technology. Although WebRTC’s core functionality is to provide secure, real-time p2p media streaming, leveraging native platform features and server-side components brings up new communication capabilities for web and native mobile applications, allowing for advanced multi-user use cases such as video broadcasting, conferencing, and media recording.
Fifty billion connected devices and still no winning protocols standards. HTTP, WebSockets, MQTT, and CoAP seem to be leading in the IoT protocol race at the moment but many more protocols are getting introduced on a regular basis. Each protocol has its pros and cons depending on the nature of the communications. Does there really need to be only one protocol to rule them all? Of course not. In his session at @ThingsExpo, Chris Matthieu, co-founder and CTO of Octoblu, walk you through how Oct...
DevOps is speeding towards the IT world like a freight train and the hype around it is deafening. There is no reason to be afraid of this change as it is the natural reaction to the agile movement that revolutionized development just a few years ago. By definition, DevOps is the natural alignment of IT performance to business profitability. The relevance of this has yet to be quantified but it has been suggested that the route to the CEO’s chair will come from the IT leaders that successfully ma...
Major trends and emerging technologies – from virtual reality and IoT, to Big Data and algorithms – are helping organizations innovate in the digital era. However, to create real business value, IT must think beyond the ‘what’ of digital transformation to the ‘how’ to harness emerging trends, innovation and disruption. Architecture is the key that underpins and ties all these efforts together. In the digital age, it’s important to invest in architecture, extend the enterprise footprint to the cl...
Almost everyone sees the potential of Internet of Things but how can businesses truly unlock that potential. The key will be in the ability to discover business insight in the midst of an ocean of Big Data generated from billions of embedded devices via Systems of Discover. Businesses will also need to ensure that they can sustain that insight by leveraging the cloud for global reach, scale and elasticity.
@DevOpsSummit has been named the ‘Top DevOps Influencer' by iTrend. iTrend processes millions of conversations, tweets, interactions, news articles, press releases, blog posts - and extract meaning form them and analyzes mobile and desktop software platforms used to communicate, various metadata (such as geo location), and automation tools. In overall placement, @DevOpsSummit ranked as the number one ‘DevOps Influencer' followed by @CloudExpo at third, and @MicroservicesE at 24th.
A critical component of any IoT project is what to do with all the data being generated. This data needs to be captured, processed, structured, and stored in a way to facilitate different kinds of queries. Traditional data warehouse and analytical systems are mature technologies that can be used to handle certain kinds of queries, but they are not always well suited to many problems, particularly when there is a need for real-time insights.
One of biggest questions about Big Data is “How do we harness all that information for business use quickly and effectively?” Geographic Information Systems (GIS) or spatial technology is about more than making maps, but adding critical context and meaning to data of all types, coming from all different channels – even sensors. In his session at @ThingsExpo, William (Bill) Meehan, director of utility solutions for Esri, will take a closer look at the current state of spatial technology and ar...
Without lifecycle traceability and visibility across the tool chain, stakeholders from Planning-to-Ops have limited insight and answers to who, what, when, why and how across the DevOps lifecycle. This impacts the ability to deliver high quality software at the needed velocity to drive positive business outcomes. In his session at @DevOpsSummit 19th Cloud Expo, Eric Robertson, General Manager at CollabNet, will show how customers are able to achieve a level of transparency that enables everyon...
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at @ThingsExpo, James Kirkland, Red Hat's Chief Arch...