On 21st July 2011 Merz Aesthetics announced that the United States Food and Drug Administration has officially approved Xeomin for the temporary improvement in the appearance of moderate to severe glabellar lines, or frown lines between the eyebrows, in adult patients.
In the UK, the cosmetic application of Xeomin is known as Bocouture, which is indicated for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at frown (glabellar frown lines) in adults below 65 years when the severity of these lines has an important psychological impact for the patient. Xeomin itself is approved for therapeutic purposes only in the UK.
“The FDA approval of XEOMIN is a significant milestone for Merz Aesthetics and a promising addition to our entire aesthetics franchise,” said Dennis Condon, President and Chief Business Officer of Merz Aesthetics, Inc. “We are confident that XEOMIN will provide patients and physicians with a new option for improving the appearance of glabellar lines.”
The approval of XEOMIN is based on the results of two pivotal U.S. clinical trials involving 16 investigational sites and included 547 healthy adult patients. In both studies, XEOMIN significantly improved the appearance of glabellar lines 30 days following the first injection, when compared to placebo. XEOMIN is the only botulinum toxin currently approved in the U.S. that does not require refrigeration prior to reconstitution.
For more information on Bocouture, visit www.merzaesthetics.com