Allergan has received a positive opinion for its Vistabel (botulinum toxin type A) from France's National Security Agency of Medicines and Health Products (ANSM) to treat moderate to severe crow's feet lines in adult patients.
The positive opinion, which follows the US 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 randomized, multi-center, placebo-controlled clinical studies of Vistabel.
The trials met their primary endpoint, showing that patients treated 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.
The company said the reduction in the appearance of crow's feet lines lasts an average of four months post-treatment.
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 said.
Vistabel is a prescription medication that works by relaxing the specific muscles that cause crow's feet lines or frown lines to form.
The positive opinion is part of the company's approval process to secure national licenses in the 27 countries in the EU as well as in Norway and Iceland.
