Merz Aesthetics announced today that they have received FDA approval for Xeomin® (incobotulinumtoxin) for the temporary improvement in the appearance of moderate to severe glabellar lines, also known as frown lines or the "elevens" in adult patients. This now presents a third option in the head-to-head battle that has been taking place between Botox® (Allergan) and Dysport® (Medicis). Who will become the "middle child" remains to be seen, but this presents some pretty interesting options for patients and physicians.
My first question was, is it approved for use in pregnant women? (The answer is no, it is catergory C- guess I will have to be wrinkled for a little while longer. ) After that I wondered, do we really need another botulinum toxin? It is already difficult to pick sides when patients ask. I like them both. I am always honest when patients ask. When I go on vacation, I know I need to use up what is in our refrigerator in the office. You don't just "throw out" good botulinum toxin. I use on myself whatever is going to be wasted. Truly. They are both great. I have to admit, though, that I do love new technology, so I am really excited to try it out.
So how is Xeomin different? Well, for starters, it doesn't have to be refrigerated. For patients, I don't think this makes any difference. For physicians however, this may make some people stop and take notice. Without the need for refrigeration, there is no need to panic during hurricanes and create a preparedness plan not only for the house and family, but also for this costly liquid gold. I live and practice in Miami- this is actually something we have to worry about. In addition, it is suggested that this product may have a shelf life of 3 years. I can't imagine having a bottle in my office that long, but practices that aren't that busy, or hoarders who like to stockpile this stuff, may find that intriguing.
In addition, it is free from complexing proteins. What, you may ask, are complexing proteins, and why does anyone care? Complexing proteins in botulinum toxins have been suggested to be present in order to stabilize the molecule, although their purpose is relatively unclear. It is clear that they play no role in the actual action of the product. These proteins have been suggested, however, to be "potentially immunogenic", meaning that theoretically, your body could build up an immunity to these proteins, and the Botox® or Dysport® may cease to be effective in patients with this immunity. Yes, this means it can stop working on some people. Merz claims that this is impossible with their new product because these ingredients are simply not present.
While newly approved for cosmetic use in the U.S., Xeomin ® has been approved for cosmetic uses in 14 countries in the European Union (EU), including Germany, the United Kingdom, France, Italy and Spain, under the brand name Bocoture®. Xeomin® first came to the U.S. in July of 2010 when it was approved for the treatment of cervical dystonia and blepharospasm.
So when can you expect to see this option offered by your dermatologist or moi? Reports say Xeomin® will be available nationwide to physicians in the spring of 2012. I will keep you posted as I receive more information and when I get my hot little hands on some of this product to try it out myself.