This month, 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) seen at maximum smile, either alone or when treated at the same time as glabellar lines seen at maximum frown in adult patients.
This is an important step towards securing national licences in the 27 countries of the European Union, as well as Norway and Iceland. This Positive Opinion follows the recent authorisation for a similar indication by the US Food and Drug Administration (FDA). The Positive Opinion is specific to Allergan’s botulinum toxin type A product and is based on the company’s successful global Phase III clinical trial programme in crow’s feet.
‘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 1350 patients. 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. This significant reduction in the appearance of crow’s feet lines was found to last an average of 4 months post-treatment. Patients treated with VISTABEL also 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, the treatment 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.
‘It’s great news for European practitioners to see that Allergan has received the first step in approval for VISTABEL within the European Union,’ said Dr Patrick Treacy, Medical Director of Ailesbury Clinics Ltd and PRIME Editorial Board Member.
‘The approval based on the results of two clinical studies involving more than 1350 patients follows the earlier FDA approval of Botox in this area 1 month ago. While the approval may not change the daily practice of most aesthetic doctors, who have essentially been using it ‘off-label’ in this area for many years, it’s still comforting for them to know a pharmaceutical product has been validated for safety and clinical effectiveness by a legal government authority.’