FRANKFURT AM MAIN--(BUSINESS WIRE)--Merz Pharma Group today announced that Bocouture® has been approved by European regulatory authorities for the treatment of upper facial lines, including horizontal frown lines, lateral periorbital lines and glabellar frown lines. Bocouture is the only neurotoxin approved in Europe* for this combined upper facial lines indication.
“Merz is a global leader in the aesthetics space and is proud to be able to provide patients and physicians in Europe with the first and only aesthetic neurotoxin approved for combination treatment of upper facial lines,” stated Philip Burchard, CEO of Merz Pharma Group. “This expanded indication for Bocouture in Europe is a result of our ongoing investments in research and development and our focus on meeting the needs of our aesthetic customers.”
Recent market research1 has indicated that the rejuvenation of upper facial lines is one of the most requested aesthetic procedures among both existing patients and those considering treatment. In clinical practice, many patients request combined treatment of upper facial lines in a single session to achieve optimal treatment outcomes.
“As the only neurotoxin treatment approved for the simultaneous treatment of upper facial lines, Bocouture supports physicians in their day to day practice and enables them to provide their patients with safe and effective treatments with confidence,” said Can Gumus, Vice President of Global Marketing Aesthetics for Merz Pharmaceuticals. “We are very proud of the fact that, while Bocouture was not the first toxin to enter the European market, it is the first product to achieve this important milestone.”
The approval of this novel treatment indication is based on the results of a pivotal randomized, double-blind, placebo-controlled Phase 3 study with 156 patients from France, Germany and United Kingdom receiving treatment of upper facial lines with Bocouture. Clinical trial data demonstrates that Bocouture has a favorable safety and efficacy profile in treating upper facial lines, both combined and separately, with treatment effects maintained for up to 4 months.
* European regulatory authorities reached consensus on approvability of Bocouture® for the indication Upper Facial Lines in 15 countries of the EU. After successful completion of the application procedure national approvals will now be granted by the member states.
For more information on Bocouture and Merz Pharma Group, please click here.
1 A market research study commissioned by Merz Aesthetics included 2899 aesthetic treatment patients and 2080 treatment considerers aged 18-64. The treated patient group comprised 2329 women and 570 men who have undergone cosmetic treatments, including dermal fillers and botulinum toxin. The respondents were from 10 countries around the world: Germany, France, United Kingdom, Russia, Australia, China, South Korea, Argentina, Brazil and Mexico.
