Merz Aesthetics announces FDA approval of Xeomin

Posted on the 04 August 2011 at 11:45

XEOMIN®, or Bocouture® as it is known in the UK, 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® is the third BoNT-A (Botulinum toxin) product the FDA has approved and is used for treatment of cervical dystonia and blepharospasm, joining BOTOX® which received FDA approval in 2000 and Dysport® in 2009. 

“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.”

“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 in Los Angeles, Calif., and Director of Skin Care and Laser Physicians in Beverly Hills, Calif.

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. 

What does this mean for the other two botulinium toxins with FDA approval on the market? Even at the time of writing there is another potential competitor being evaluated by the FDA for the reduction of glabellar rhytides called PurTox® by Mentor Corporation.  Despite the competition, it seems BOTOX® is still the worlds dominating brand with Allergan reporting a 13.3% rise in sales in the first 2011 quarter alone.

For more information see: http://www.merzaesthetics.com/en-US/news/announcing-xeomin.cfm

Add Comment

To leave a comment you need to be logged in as a Cosmetic Community Member or a Clinic.

Please Click Here to login / register with the Cosmetic Community.

If you are a Clinic Click Here to login to the partners area of Consulting Room.