Merz Aesthetics said the FDA has approved XEOMINR (incobotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe glabellar lines, or frown lines between the eyebrows, in adult patients.
"XEOMIN is a promising new option for both patients and physicians and we are encouraged by the response rates seen in the phase III clinical trials," said Derek H. Jones, M.D., an investigator for the XEOMIN U.S. study, clinical associate professor of medicine at the University of California Los Angeles, and director of Skin Care and Laser Physicians in Beverly Hills, Calif.
The approval of XEOMIN is based on the results of two U.S. clinical trials involving 16 investigative sites and 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.
XEOMIN is approved for the temporary improvement in the appearance of glabellar lines in 14 countries in the European Union including Germany, the U.K., France, Italy and Spain, under the brand name BOCOUTURER.