The battle of the facial wrinkle reducers continues to become more competitive. Botox has always been the gold standard because it was first and largely established the market as it exists today. Several years ago Dysport entered the scene which initially caused a bit of buzz. But to date it has not eroded dramatically Botox’ dominance in the aesthetic facial market. This is mainly because Dysport does not offer any significant differences in its effects to either the doctor or the patient. With a minimal price difference, it is perhaps no surprise that Dysport has not offered up a real challenge to Botox as of yet.

More recently a third player entered the facial wrinkle reducer market known as Xeomin. Like Botox and Dysport, it is a form of botulinum toxin known as incobotulinum toxin A. It has similar muscle paralyzing effects and is approved like the other two based on the predicate treatment site of the frown lines or ‘11s’. It is already FDA approved and used in adults for cervical dystonia and eye twitching. It is manufactured by Merz Pharmaceuticals who also has the aesthetic products of Radiesse filler and Asclera sclerotherapy agents.

While it is a competitive analogue, what makes Xeomin different if anything from Botox and Dysport? The most obvious difference is that it does not need to be refrigerated. This may seem like a trivial difference that only matters to the doctor, but it has great relevance to the patient as well. If Botox or Dysport is mixed and accidentally not refrigerated, it becomes ineffective quite quickly. If someone has ever had a facial injection and it did not work, it may have been caused by  a ‘bad’ drug mixture that was allowed to get warm or had been forgotten to be refrigerated overnite. This is also a benefit in the way the drug is distributed and shipped from the manufacturer. The other minor difference is that Xeomin  is manufactured without additives. This may lessen the potential for any drug reaction problems.

Otherwise, Xeomin is report to be more similar to Botox than Dysport. This is said from the perspective that it takes about one week for the full effects of the drug to be seen. Only Dysport has a faster onset. Otherwise, all of them have the same duration of effect of around four months. The cost of Xeomin is as of yet unknown but I suspect it will not be substantially less in cost than Botox. This will place the treatment of the glabellar furrows (11s) around $350 to $500.

Where will Xeomin fit into the injectable facial wrinkle market? Without a substantial performance difference or cost benefit, it will likely end up similar to the fate of Dysport so far. Occupying a small percent of the market and, like Dysport, being the Pepsi compared to Coke.  

Dr. Barry Eppley

www.eppleyplasticsurgery.com

Indianapolis, Indiana

Aesthetic neuromuscular modulators, known more commonly as Botox, Dysport and now Xeomin, has been a decades old concept from an FDA standpoint….and twice that long as an off-label use for the treatment of unwanted facial expressions and wrinkles. Because the dose of each of these injectates will vary between each patient, it has become clear that their use is as much art as it is a science. While manuals exist as guidelines for where to inject and doses to use, each patient must still be treated individually.

The dosing issue has become more complicated now that there is more than just Botox available. Most physicians feel that there is a 3:1 unit comparison between Dysport and Botox and the jury is still out on where Xeomin will compare. I generally use 24 to 30 units of Botox for the glabella, frontalis and crow’s feet areas, the most common area for neurotoxin use. This works well for most patients and is a good value point for a cosmetic treatment that will last around four months. By comparison, the comparative dose of Dysport would be 70 to 90 units for the same areas.

There remains some controversy about whether Botox or Dysport is ‘better’. There is tremendous brand loyalty amongst providers to Botox and the company certainly does a lot of marketing and promotions to maintain it. I think Dysport has done a relatively poor job of how it markets and promotes its equivalent and, as a result, it continues to be occupy a relatively small piece of the injectable neurotoxin market in the United States. Whether that will change depends ultimately on how well it works in the years ahead.

It appears fairly clear that Dysport does have a few days of earlier onset and a greater zone of diffusion than Botox. This makes it preferable to those who want to have a quick onset of action and may be better in the crow’s feet area where the orbicularis muscles are broad. Because of this greater diffusion, some feel that it has a higher risk of unintended effect in areas where numerous muscles have opposing actions such as around the mouth. I have heard and read that Dysport lasts longer and is more cost-effective but these claims are not substantiated by any clinical study.

Unlike ten years ago, the one area that Botox and its competitive analogues have had increasing use is as an adjunct and sometimes a replacement for surgery. For many patients, reducing muscle action in the forehead can delay or eliminate the need for a surgical browlift. While this so-called chemical or pharmacologic browlift is very useful in the forehead, it is ineffective for the mid- or lower face as a lifting technique. For those patients actually undergoing a browlift, injecting Botox either before or after the procedure can enhance the results. I find it particularly useful in my Indianapolis browlift patients for injecting during surgery to get the best lift possible in the tail of the eyebrow. This is an area that can be the most difficult to surgically lift as opposed to the central brow.

Another area that injectable neuromuscular modulators are very helpful is in laser skin resurfacing. By injecting at least a week before surgery, the muscles are relaxed so there is not as much pull on the healing skin as it is healing. That does provide some better comfort although touting it as promoting better healing is not based on any science. A good protocol that I use is to inject Botox two weeks prior to laser resurfacing and then again at three or four months afterwards to maintain a good smooth result. Keeping the muscles relaxed will also prolong the results of many non-surgical treatments besides laser resurfacing such as injectable fillers, chemical peels, and skin tightening devices. (Skin Tyte, Thermage, Ulthera)

Dr. Barry Eppley

www.eppleyplasticsurgery.com

Indianapolis, Indiana

Botox continues to be one of the top non-surgical (really minimally invasive) cosmetic procedures. In combination with injectable fillers, a whole new area of cosmetic improvements has been made possible. While Botox dominated the cosmetic neuromuscular market for almost a decade, its success was certain to lead to competition. Such was the case in the summer of 2009 when Dysport received FDA approval in the United States for cosmetic applications. Now we have both Botox and Dysport available although the battle is shaping up to be more like Coke and Pepsi. It is likely that Botox will dominate the market for the foreseeable future until…a competitor comes along that offers a neuromuscular product which is either substantially cheaper or lasts longer.

Interestingly, last week Merz Pharmaceuticals announced that it has received FDA approval for its botulinum toxin product,  Xeomin. (technically incobotulinum toxin A) It is only currently approved for the treatment of adults with blepharospasm or cervical dystonia. To some, those applications may seem obscure but that is exactly what Botox was initially approved for way back in the 1990s. While this drug is not yet approved for cosmetic facial use, there is no doubt that is in the manufacturer’s plan in the future as soon as possible.

The results from the reported clinical trials for the use of Xeomin were in adult patients diagnosed with either cervical dystonia or blepharospasm.  Other comparison studies with Botox showed that it had a similar effectiveness and side effect profile for these applications.

Like Botox, Xeomin is an injection that blocks the transmission of nerve pulses into the muscle. But it appears to have some pharmacological differences. It is reported to have increased biological activity which may or may not mean that it is more effective at lower doses.  It has less ancillary proteins, so it is more pure, and thus may be less prone to develop drug resistance.The drug also does not need to be refrigerated unlike Botox and Dysport. That is only a minor benefit to the injector but a major one to the manufacturer due to shipping issues.

The key questions as they relate cosmetic use is how does Xeomin compare to Botox and Dysport in effectiveness and cost. While no clinical studies have yet been reported, every indication is that the onset of the effects is the same (one week) and its length of action is similar. (3 to 6 months) Its cost is not presently known so the idea that it may be less expensive is theoretical and likely over optimistic.

Early evidence suggests that Xeomin is going down the Dysport road…an alternative to Botox without appreciable upfront differences to the consumer. While it is not FDA-approved for cosmetic use, it will no doubt be used off-label long before it ever receives that blessing.

The manufacturer, Merz, is adopting a market strategy similar to its competitors. It has acquired Bioform Medical, the manufacturer of the injectable facial filler Radiesse. As a company it is key to have a dual cosmetic injection approach, a neuromuscular paralyzer and a volume filler. Merz appears poised to make its entrance into the cosmetic marketplace.

Dr. Barry Eppley

www.eppleyplasticsurgery.com

Indianapolis, Indiana