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Posts Tagged ‘xeomin’

Xeomin vs. Botox Neurotoxin Injections

Sunday, September 6th, 2015

 

Botox is the undisputed king of aesthetic neurotoxins since it was officially FDA approved in 2002. While newer neurotoxins from different manufacturers have since emerged (Dysport, Xeomin), they have not and likely never will topple the market share that Botox currently has. Most likely it will waver with modest changes back and forth very similar to what goes on the soda market battle of Coke vs. Pepsi.

But just because these other neurotoxins have a much smaller piece of aesthetic neurotoxin pie, does that mean they are inferior products? It is generally believed that all three neurotoxins are equivalent in terms of effectiveness and in how long they last. Botox is much better known, not only because they were the first neurotoxin FDA-approved and revolutionized the aesthetic facial industry, but because its manufacturer Allergan has done an outstanding job with its branding efforts.

Xeomin Injections Indianapolis Dr Barry EppleyAs the last of the neurotoxin three to enter the market, the comparative effectiveness of Xeomin has not been backed up by any good comparative science. A recent study, however, may finally put that issue to rest. In a recently reported prospective double-blinded study Xeomin and Botox went head to-head in the treatment of glabellar frown lines in several hundred women using 20 units of each drug. The study showed equivalence in terms of time of onset, peak effect, number of complications and patient satisfaction levels. Such study information is critical as doctors had to rely on their own experience and word of mouth as to the merits of Xeomin.

Despite its equivalence to Botox, the use of Xeomin is going to be highly influenced by the practice behavior of the injector. Some practices use all three neurotoxins while others may only use one exclusively. Personal preference, brand familiarity, practice behavior and cost all lead to preferences of neurotoxin use. The cost issue is what aspect where Xeomin excels over Botox. It comes at a lower acquisition cost and these savings can be passed onto the patient.

Change is difficult and for this reason many patients may not be willing to leave Botox for a different neurotoxin. But because of clinical equivalency neurotoxin experimentation is possible with no downside.

Dr. Barry Eppley

Indianapolis, Indiana

Botox vs. Xeomin for Upper Facial Wrinkles

Wednesday, May 27th, 2015

 

Aesthetic facial neuromodulation, aka ‘Botoxing one’s face’, is a long proven method for reducing the development of certain facial wrinkles and unwanted facial expressions. It has been done for so long and with such success that the original facial neurotoxin and still the most popular, Botox, has worked its way into the cosmetic procedure lexicon as a verb.

Botox Facial Wrinkle Injections Dr Barry Eppley IndianapolisBut Botox is not the only player in the injectable neurotoxin market as two ‘younger’ products have appeared in the scene in the last five years, that being Xeomin and Dysport. While all three advertise, promote whatever subtle differences that may exist between them and physicians have their preferences between them for their own reasons, but it is not really clear whether one is more or less effective than the other.

In the May 2015 issue of Plastic and Reconstructive Surgery journal, the article entitled ‘A Prospective Split-Face, Randomized, Double-Blind Study Comparing OnubotulinumtoxinA to IncobotulinumtoxinA for Upper Facial Wrinkles’ was published . In this paper a clinical study was published on 45 patients (41 women and 5 men) who had three types of facial wrinkles treated  using a 1:1 dose ratio of Botox and Xeomin. A total of 50 units of each drug was administered to the upper face in three areas. (glabella, forehead and crow’s feet) and evaluated over a four month period. The effect on the wrinkles was assessed by a scale amongst blinded physicians. For toxin comparison, the researchers calculated differences in the degree of wrinkle scale at each period compared with pre-treatment and performed statistical analyses. They analyzed wrinkle types both individually and combined.

Xeomin Indianapolis Dr Barry Eppley IndianapolisTheir results showed that at identical doses, both Botox and Xeomin are safe and effective in the treatment of upper facial wrinkles. However, Botox  had statistically greater effectiveness in dynamic wrinkle reduction at each point in the study out to four months. This would suggest. although does not prove, that Xeomin may need higher doses to be equally effective.

Dr. Barry Eppley

Indianapolis, Indiana

Comparing Botox, Dysport and Xeomin Injectable Facial Neuromuscular Modulators

Sunday, April 20th, 2014

 

The announcement this month that Johnson & Johnson (J & J) has pulled any further development of their aesthetic neuromuscular modulator PurTox was a surprise. It was certain several years ago that a fourth injectable drug would soon be on the market to compete with the big three, Botox, Dysport and Xeomin. But it now appears that these three cosmetic drugs will only have only to compete amongst themselves for some time into the foreseeable future.

Botox Facial Wrinkle Injections Dr Barry Eppley IndianapolisIt has now been three years since the last of the big three (Xeomin) was approved. And while there has been some minor new FDA approvals for indications that were already widely done off-label anyway (crow’s feet), the number of men and women seeking this injectable cosmetic treatment continues to grow. Having multiple products to treat unwanted facial lines and wrinkles has helped create awareness and grow the market. These drugs today are as accepted as capuccinos and are done almost just as much. To some degree, Botox and his competitors have very much become commodities where the lowest cost per unit often sways what provider/location that a patient will go to.

This raises the question of how do these drugs differ and, what advantages if any, do any of them offer over the others? What all three drugs share is that they are FDA-approved Type A botulinum toxins. They work exactly the same through the same mechanism of molecular action and all have the same type of heavy chain receptor. While Dysport and Xeomin have a little shorter onset (1 to 2 days), they last the same amount of time as Botox having a duration of action of between 3 and 4 months after injection.

Dysport Indianapolis Dr Barry EppleyThey do differ significantly, however, in their dosing and methods of storage. The dosing of Dysport is very different from that of Botox or Xeomin. This makes it difficult to compare Dysport to the other two in clinical studies. While the biologic activity is the same for Botox and Xeomin, it is quite different for Dysport and there is no standard dose conversion. While all three must be reconstituted on the day of administration, Xeomin does not require refrigeration which makes it more portable and not prone to be accidentally left out of cold storage after a treatment.

From a marketing and public awareness standpoint, Botox is the dominant force occupying close to 80% of the market. It is the ‘Coke’ of the injectable neuromuscular modulators, the most studied and also the most expensive. Dysport and Xeomin are the ‘Pepsi’ and ‘Seven-Up’ by comparison and are still trying to gain market share. As a result they are priced under that of Botox and is there only real method of improving their small market share given that they have no other advantages.

Xeomin Indianapolis Dr Barry Eppley IndianapolisSome small claimed advantages over Botox for Dysport is that it has wider zone of diffusion from the injection site. This may be an advantage in the bigger muscles areas of the frontalis muscle of the forehead and the orbicularis muscle of the crow’s feet area. But would be a disadvantage in a discrete muscular area like the glabella which is also the number one area for all aesthetic neuromuscular injections. Xeomin claims a less risk of allergic reaction than with Botox because it does not contain hemagglutin and non-hemagglutin complexing proteins. While this may be theoretically true, the incidence of allergic reactions to Botox is so insignificant after over twenty years of clinical use that this advantage is meaningless.

While there are other aesthetic injectable neuromuscular drugs under development, none of them seem to have any major advantages over the big three that are available now. Every patient would like them to last longer (or be permanent) and cost less but that does not appear to be likely for as far as one can see into the future. The one promising approach is that of a topical botulinum type A gel of which several companies have ongoing clinical trials. Avoiding needle sticks could be the one advantage a new product could have that would help shakeup the market as we know it now.

Dr. Barry Eppley

Indianapolis, Indiana

Plastic Surgery Product Review: Xeomin Injectable Facial Wrinkle Reducer

Monday, November 28th, 2011

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

Indianapolis, Indiana

The Evolving Role Of Neurotoxins for Aesthetic Facial Improvements

Wednesday, November 9th, 2011

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 unitsof 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 asinjectable fillers, chemical peels, and skin tightening devices. (Skin Tyte, Thermage, Ulthera, Exilis)

Dr. Barry Eppley

Indianapolis, Indiana

New Injectable Aesthetic Treatments

Wednesday, September 14th, 2011

The growth of injectable aesthetic treatments is largely fueled by the number of products that are available to use. Between neuromuscular paralyzing agents, volumizing fillers and sclerotherapy agents, there are over fifteen products currently available. That is about to grow by two new products and on-label indications.

Moving alongside Botox and Dysport will be Xeomin offered by Merz Aesthetics with its recent approval earlier this year. Like its predecessors, it has been approved by the FDA for temporary improvement in the appearance of moderate to severe glabellar (between the eyebrow) lines in adults. (between ages 21 to 65) What its advantages may be, if any, over Botox and Dysport remain to be forthcoming. As a different molecular structure of botulinum toxin, incobotulinumtoxin A, it is likely to have most of the working properties of the botulinum toxins such as delayed onset of action, limited zone of diffusion and a lifespan of three to four months. Its unit dosage and its pricing point will be interesting to see what the company offers and how it compares to its competitors.

While Restylane and many other injectable fillers have been around for awhile, it would surprise many that they have never been approved by the FDA for lip augmentation. This is interesting given that lip injections make up a significant percentage of the product’s use in most practices. This means that lip enhancement by fillers has been used off-label for more than a decade. Restylane, introduced initially in the U.S. in 2004 by Medicis Aesthetics, has been recommended recently by an FDA advisory panel to expand its approved indications to that of the lips. While this does not formally mean the FDA will do so, it is more likely than not. While this doesn’t provide any new benefits to injectable lip augmentation per se, it is comforting to know that its well known safety and effectiveness is scientifically recognized.

Sclerotherapy has used injectable products such as hypertonic saline and sodium sotradecol for decades without any new technology innovations. In the past year, a new sclerotherapy solution has been introduced that is widely used around the world. Asclera, pilodocanol, has been FDA-approved and released by Merz Aesthetics. This is for sclerosing uncomplicated spider veins (very small varicose veins less than 1mm in diameter) and small varicose veins (1 to 3mms) known as reticular veins. Asclera works similarly to other sclerosing agents by damaging the endothelium which is the lining inside of blood vessels. This causes blood platelets to attach to the lining of the vessels, causing the blood vessel to clot. Over time, the clotted vein will be replaced with scar tissue. Without blood flow, the spider veins ‘disappear’. With a similar mechanism of action, the question is how Acsclera may be superior to existing products. It is believed that it works more effectively and with less injection discomfort than its predecessors.

The infusion of new products like Xeomin and Asclera and expanding indications of existing products, like Restylane for lips, will continue to fuel the growing field of office-based injectable cosmetic treatments.

Dr. Barry Eppley

Indianapolis, Indiana

The Influence of Botox on Emotional Expressions

Tuesday, August 17th, 2010

Any drug that can change facial expressions can certainly influence how other people see and interpret you. But can they also change how you feel as well?

In the June 2010 issue of Emotions, researchers out of New York published a paper which reported that people who were treated Botox treatments not only change their appearance but may also had a weakened ability to experience emotions.

The facial feedback hypothesis (FFH) in psychology has long purported that if an emotion can not be expressed physically then it really doesn’t exist. It has remained largely an unproven theory as it is difficult to isolate an emotion as a physical loci. But the widespread use of Botox, a muscle weakening agent used for cosmetic wrinkle reduction, can suppress emotion by its effect on facial muscle units. This now makes it possible to work with people who have a chemically-induced expressive muscle weakness.

As a result, the theory of FFH can be tested for the first time. A person who has received treatment with Botox can still respond to an emotional event (something that makes them angry) but their facial muscles will be less active. Less muscle stimulation to the brain results with less feedback to the brain about what the face is expressing. This allows for a test of whether facial expressions and the feedback to the brain that it creates can influence our emotions.

The reported study used two groups of patients, one who got Botox injections and a control group which received a cosmetic filler (Restylane) which does not affect the facial muscles. Such a study design allows one to isolate the effects of facial expression and the subsequent sensory feedback to the brain that would follow from other factors, such as intentions relating to one’s expressions and motor commands to make an expression. In the study, the subjects filled out questionnaires about how they felt after watching positive and negative video clips before and after treatment.

The findings of the study shows that those who received Botox had no changes between the pre- and post-treatment emotional responses to the most positive and negative video clips. But, compared to the control filler group, Botox patients had much lower strengths of emotional responses. Their conclusions were that feedback from facial expressions is not necessary to have an emotional experience, but it may modify the intensity of that emotional experience.

Considering the number one reason people have Botox is to decrease the frowning or scowling between their eyebrows, this may also help people feel less angry and irritated. So maybe Botox, and its cousins Dysport and Xeomin, really are tranquility drugs as well.

Dr. Barry Eppley

Indianapolis, Indiana

Xeomin Botulinum Injections – An Alternative to Botox and Dysport

Tuesday, August 10th, 2010

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

Indianapolis, Indiana


Dr. Barry EppleyDr. Barry Eppley

Dr. Barry Eppley is an extensively trained plastic and cosmetic surgeon with more than 20 years of surgical experience. He is both a licensed physician and dentist as well as double board-certified in both Plastic and Reconstructive Surgery and Oral and Maxillofacial Surgery. This training allows him to perform the most complex surgical procedures from cosmetic changes to the face and body to craniofacial surgery. Dr. Eppley has made extensive contributions to plastic surgery starting with the development of several advanced surgical techniques. He is a revered author, lecturer and educator in the field of plastic and cosmetic surgery.

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