Allergan’s VISTABEL® (botulinum toxin type A) Receives Europe’s First Positive Opinion for Treatment of Moderate to Severe Lateral Canthal Lines (Crow’s Feet Lines) in Adult Patients

Posted: 23 October 2013 | | No comments yet

Positive opinion paves the way for a second aesthetic indication for VISTABEL® in 29 European countries…

Today, Allergan Inc. announced that VISTABEL® has received a Positive Opinion from the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) 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. This is an important step towards securing national licences in the twenty seven countries of the European Union as well as Norway and Iceland. This Positive Opinion follows the recent authorisation for a similar indication by the U.S. Food and Drug Administration (FDA). The Positive Opinion 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.

“At Allergan, we have a long-term commitment to innovation in neuromodulator research, and this Positive Opinion is testament to this,” said Paul Navarre, President of Allergan EAME. “This is an important milestone for Allergan, extending our commitment to support medical aesthetics practitioners by delivering the scientific evidence, the appropriate country licences to promote the drug and the educational training programs to yield the best possible outcomes for patients.”

The European Positive Opinion for the use of VISTABEL® 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 VISTABEL® 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 lasting an average of 4 months post-treatment.1 Patients treated with VISTABEL® 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.

“Crow’s Feet Lines are amongst the top ageing concerns for people in 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 Dr. Koenraad de Boulle, Dermatologist and a key investigator in the registration trials. “I’m pleased Allergan invested in the additional research to demonstrate that treatment with VISTABEL® can deliver a refreshed look by softening the appearance of Crow’s Feet Lines as well as the glabellar lines.”

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