Allergan, Inc. have 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 and 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 1350 patients. 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 4 months post-treatment. In general, patients treated with BOTOX® reported that they looked younger and more attractive.
In these studies, Allergan’s botulinum toxin type A product was generally well tolerated. 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.
‘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.’