EMA approves Alluzience for glabellar lines.- Galderma

Designed for precision, Alluzience is a liquid form of botulinum toxin type A intended for use in adult patients as a treatment to temporarily improve the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows), when the severity of these lines has an important psychological impact on the patient.The European Marketing Authorization Application of Alluzience is based on pooled data from two pivotal trials of 372 patients with moderate to severe glabellar lines who were treated with either Alluzience (n=250) or placebo (n=122). These data demonstrated that >50% of patients reported an effect within two to three days, including 23% of patients within one day. An effect was demonstrated for up to six months after injection with Alluzience. The responder rate at day 29 was significantly higher for patients treated with Alluzience compared to placebo (primary endpoint) (p<0.0001). additionally, patients’ level of satisfaction one month following injection showed that 85.2% of the patients receiving alluzience were either satisfied or very satisfied compared to 9% for placebo patients. the majority of adverse reactions reported with alluzience in clinical trials were of mild to moderate intensity and reversible. the most frequently reported adverse reactions were headache and injection site reactions.></0.0001).>