Allergan's BOTOX Vista Receives National Marketing Authorisation In Japan

(RTTNews) - Allergan plc (AGN) said that the Japanese Ministry of Health, Labour and Welfare has approved an additional use for BOTOX Vista (Allergan's botulinum toxin type A product) as a treatment for crow's feet lines (CFL). BOTOX Vista is now indicated for the temporary improvement in the appearance of lateral canthal lines (CFL) in adult patients under the age of 65.3 This marketing authorisation is specific to Allergan's botulinum toxin type A product.

The licence for BOTOX Vista to treat CFL is based on a phase 3 clinical study in Japan involving 300 patients. Of the patients who received a single dose of BOTOX Vista at 12 units or 24 units, over 56.5% and 68.3% respectively achieved an improvement of the appearance of CFL at day 30, compared to those patients who did not receive botulinum toxin type A treatment (8.2% with placebo).

In a second phase 3 study patients received concurrent treatment of CFL (12 units or 24 units) and glabellar lines (20 units) with BOTOX Vista in up to 4 treatment cycles. More than 80% of patients reported an improvement in the appearance of CFL at day 30 after each treatment cycle. In both studies, adverse reactions were limited and Allergan's botulinum toxin type A product was generally well tolerated.