Allergan has received a positive opinion for its Vistabel (botulinum toxin type A) from France’s Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), for the treatment of moderate to severe lateral canthal lines (crow’s feet lines) in adult patients.
ANSM’s positive opinion, which follows the US Food and Drug Administration’s (FDA) approval for a similar indication, is specific to the company’s botulinum toxin type A product and is based on the Phase III clinical trial results in crow’s feet lines.
Around 1,350 patients were involved in the two randomised, multi-centre, placebo-controlled clinical studies of Vistabel.
The studies met their primary endpoints, showing that patients treated with Vistabel achieved none or mild lines according to investigator assessment at day 30, compared with those patients who did not receive botulinum toxin type A treatment.
According to the company, the significant reduction in the appearance of crow’s feet lines lasted an average of four months post-treatment.
Allergan EAME president Paul Navarre said: "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 programmes to yield the best possible outcomes for patients."
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The company said its botulinum toxin type A product may cause side effects, but the incidence rate might be variable.
Dermatologist and a key investigator in the registration trials Koenraad de Boulle said 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," de Boulle added.
Vistabel is a prescription medication that works by relaxing the specific muscles that cause crow’s feet lines or frown lines to form.
France serves as the reference member state in the mutual recognition procedure for Vistabel and following its positive opinion, the healthcare regulatory agencies in the 27 countries of the European Union, as well as Norway and Iceland will likely finalise their respective national licences.