- Dr. Weiner is Board Certified in Facial Plastic Surgery and is an expert on the anatomy of the face. He trained, and was a faculty member, at the number one rated Otolaryngology/Head and Neck Surgery Department in the country at The Johns Hopkins Hospital.
- He started injecting Botox in 1994. His initial uses for Botox were for spasms of the vocal cords and neck, as well as excessive muscle tension, particularly in the TMJ area. Even prior to FDA approval for cosmetic use, Dr. Weiner was using Botox for improving wrinkles around the crows feet and forehead in the late 90’s.
- Dr. Weiner is a physician trainer for injections techniques of: Sculptra, Restylane, Restylane Silk, Restylane Lyft, Bellafill, and Dysport.
- Dr. Weiner is a lecturer for Galderma (Restylane Family of Products, Sculptra, Dysport) and Suneva (Bellafill)
- Multiple techniques (cooling, vibration, small needles) are used during the injections to minimize the discomfort without the use of “dental blocks”
- Dr. Weiner is on the physician’s advisory board for Allergan (Botox, Juvederm, Voluma, Kybella)
- Dr. Weiner is a Key Opinion Leader (KOL) for Bellafill.
- Dr. Weiner is the only one that injects neuromodulators and fillers at The Aesthetic Clinique
- Dr. Weiner has experience with all the FDA approved neuromodulators (Botox, Dysport, Xeomin, Myobloc) and fillers (Restylane, Restylane Silk, Restylane Lyft, Juvederm, Voluma, Radiesse, Bellafill, Sculptra, Belotero, Prevelle Silk, Evolence (off market), and Cosmoderm (off market).
- Dr. Weiner uses exclusively blunt tipped cannulas for his filler injections (except Restylane Silk in lips) since 2012. Cannulas are much safer and lead to less bruising, less discomfort, less complications, and less downtime. Less than 5% of providers use cannulas.
- Fillers, neuromodulators, and lasers are all Dr. Weiner does at the Aesthetic Clinique for the past 10 years. He is completely focused on Aesthetic Medicine.
- Dr. Weiner has participated in 2 clinical trials for Juvederm.
- If there is bruising after treatment, Dr. Weiner offers complimentary laser treatment with the Excel V. This is a couple minute procedure that decreases the duration of bruising from up to 2 weeks, down to 1 or 2 days.
- All patients are photographed with TouchMD, which allows for patients to see their own before and after photos either online or on a phone app.
- 3D photos are taken of all filler patients to show the volume improvements much more precisely than 2D photos.
- There is an extensive library of videos on Dr. Weiner’s YouTube channel that shows his techniques so patients can learn what to expect during their visit. Gain confidence and trust even before the actual visit.
- Dr. Weiner is a Presidential Champion Level for Galderma, the highest volume level for their products: Restylane, Restylane Silk, Restylane Lyft, Sculptra, and Dysport.
- Dr. Weiner is a Platinum Plus Level for Allergan Products: Botox, Juvederm, and Voluma.
Removing and reducing fat in Americans is a huge industry in the Aesthetics market. There are multiple ways to do this:
- Suction (traditional) Liposuction
- Laser Liposuction
- “Tickle” (vibration) Liposuction
- Water Liposuction
- Freezing the Fat (Coolsculpting)
- Heating the Fat (Vanquish, TruSculpt, Sculpsure, Ultrashape, Liposonix)
- Chemically with Injections (Kythera’s Kybella, Neothetics 102, 202)
There are positives and negatives to all the above methods. Some are more aggressive but have more downtime and risk. Pain is a limiting factor for wide acceptance with others. Devices tend to cost the physician $80,000 and up, which keeps costs high to patients. The public demands little to no downtime with reasonable costs.
Kybella’s FDA approval recently has opened up a new way to remove fat…using just injections. Kybella drug, deoxycholic acid, is a bile salt. It is normally excreted by the liver to aid in the breakdown of fat that is ingested. It has been shown to be effective in reducing the double chin fat through a series of injections. Most people will require between 2-4 treatments. The fat cell that is affected is permanently killed. That doesn’t mean your chin will stay the same after you are done with treatment. Residual fat cells will enlarge, if there is an overall weight gain due to eating habits, exercise change, or other systemic disease. There are already trials going on to use Kybella for other areas and it is just a matter of time that it will be approved for the excessive abdominal fat. It seems like a great way to remove fat…but there is one catch. There is swelling and discomfort for a few days at least. Most will overlook this minor point, but it is just this issue that makes room for Neothetic’s Lipo 102 to become a blockbuster. Neothetics doesn’t cause the fat cell to lyse (burst open) and therefore leads to significantly less inflammation and swelling.
Neothetics is researching Lipo 202 for abdominal fat reduction and Lipo 102 for fat reduction in the eye area for Graves disease patients (off label use for treating cosmetic unsightly fat bulges around the eye is obviously their intention). Neothetic’s Lipo 102 and 202 are both made with salmeterol xinafoate. Salmeterol is an asthma drug, a beta adrenergic agonist. In layman’s term, this drug acts like adrenaline (epinephrine). Fluticasone is a strong steroid and helps reduce swelling and is added to Lipo 102. The way Lipo 102 and 202 work on fat is that the salmeterol mimics exercise of the fat cell, by increasing the metabolism of the cell. Glycerol and fatty acids are expelled from the fat cell because it percieves (it is tricked into believing) that the body needs these energy sources. This will result in shrinkage of the fat cell. Just as with Kybella, multiple treatments are needed.
One of the big questions is: “How long do results last with Lipo 102 or 202?”. This question is being researched in a follow up study to the phase II study on abdominal fat using Lipo 202. Although a concern to investors, whether or not the results are long standing or not is almost irrelevant in the authors opinion. For a procedure that is 5 minutes from start to finish, with very little downtime, it’s perfectly acceptable to require touch ups months after treatment. This is the norm for Botox, dermal fillers, laser procedures, and skin tightening procedures.
The hidden gem with Neothetics is Lipo 102. There is currently no easy way to treat fat around the eye without surgery. Lasers have been tried and were abandoned because of numerous complications. If there were a way to reduce bulging fat around the eye with injections, it would be a HUGE drug. Kybella has too much swelling to be considered for this area. The eye cannot tolerate post septal swelling (within the orbit) without risk to visual loss. It is conceivable that the procedure would be similar to getting Botox around the eye, but in a slightly different area, with little to no downtime. Again, the need for touch ups would be perfectly acceptable to most patients as long as pain, risk, and downtime are minimal.
Neothetics’ Lipo 202 for treating abdominal fat in less than 5 minutes with injections seems like a great story. However, Lipo 102 has an even greater potential and without competitors for treating the bulging eye fat. With the recent acquisition of Kythera by Allergan, the other 2 large players in the aesthetics industry, Galderma and Merz, may want to have a competitor to Kybella. A fat busting injectable seems to fit in well with the offerings of either company, but it’s the authors opinion that Merz will eventually be the buyer of Neothetics later this year. With Kythera being bought by Allergan for $2 Billion, and Neothetics $146 Million Market Cap, with $70 Million in cash, it makes the buy out all more likely. In addition, there were several insider buys at the IPO price of 14 when NEOT went public late last year. There have been no insiders selling after the IPO despite the stock’s dip to just under 6 a few weeks ago. Since the purchase of KYTH by Allergan, the stock has moved up to 10.73 on large volume.
Disclosure: Dr. Weiner is a share holder of Neothetics (NEOT) and was a shareholder of Allergan (AGN) and Kythera (KYTH). At the time of posting this blog, NEOT had closed at 10.73.
Juvederm Voluma was approved by the FDA today for treatment of age related volume loss in the cheek area. This is the first filler to be approved for this purpose. Its main component is Hyaluronic acid which is also found in Juvederm Ultra, Restylane, Perlane, and Belotero, all FDA approved fillers. Juvederm Voluma is a thicker, more viscous version of Juvederm Ultra which gives it more “substance”. The technical term for this property is called “G prime”. The higher the G prime, the better ability for the filler to lift and support skin and surround structures. Compared with Juvederm Ultra, Juvederm Voluma has about 10 times (10X) the G prime. A comparison graph is shown below (from Going With the Flow: An Overview of Soft Tissue Filler Rheology and Its Potential Clinical Applications, Part II by Hema Sundaram, MD, FAAD):
As seen in the chart, Radiesse, Perlane, and Restylane have higher G primes than Juvederm Voluma. Although these others are not approved for volume loss of the cheek, they are all used commonly “off label” for this application.
Being very thick/viscous, Voluma will need to be injected with large bore needles or blunt cannulas. It is mixed with lidocaine (numbing medication) from the factory, so the procedure is very well tolerated. It’s longevity is longer than most fillers, lasting up to 2 years in their clinical trials. At 2 years, 76% of patients were still satisfied with their Voluma results. (It was 90% at 6 months). Also, at 2 years, the average patient’s perception was that they looked 3 years younger since the Voluma treatment. (It was perceived as 5 years after 6 months).
Obviously, the volume needed for correction varies from patient to patient, depending on their degree of volume loss. During the clinical trials, the average volume needed for correction was just over 6cc. Some patients needed up to 13 syringes.
An advantage of Voluma over Radiesse, Artefill, or Sculptra is that Voluma can be “erased” or dissolved with an easily obtained enzyme called hyaluronidase. Although it is seldom used, it can give patients the piece of mind that their results don’t have to last for a year if they aren’t happy with it.
Initially, Voluma is being released to a select number of physicians who are very experienced injectors. These physicians will then become trainers for the other physicians with less experience. Dr. Weiner has been chosen as one of these initial users of Voluma, and it should be available at his office in November.
Dr. Weiner is Facial Plastic Surgeon who laid down his scalpel in 2005 and now concentrates on minimally and noninvasive cosmetic procedures. His website is http://www.theclinique.net His YouTube is: http://www.youtube.com/user/StevenFWeinerFacial
Botox was originally FDA approved for treating stabismus (lazy eye) and blepharospasm (spasms of the eyelids) in 1989. When treating around the eye, patients and doctors were noting the wrinkles around the eyes were improving and brows were elevating. Studies were then initiated by Drs. Jean and Alastair Carruthers to test the cosmetic effects of Botox. It actually took 4 years to recruit enough patients to complete the study. In 2002, the first indication for Botox cosmetic use in the glabella (frown line) was approved. Botox has since become the most popular cosmetic procedure in the world. Its no downtime, consistent and effective results have made it a mainstay for people desiring a quick wrinkle improvement. Earlier this year, the FDA approved the second indication: for use in the lateral canthal rhytids (crows feet). Although the crows feet and other areas of the face and neck have been used (legally) off-label since the early 2000’s, this new approval will allow the company, Allergan, to market this new indication to the public. This will create more public awareness about what Botox can do, and make it even more popular.
The newest buzz about Botox is a technique that has been used by Dr. Weiner for several years is called “MicroBotox”. This is when the diluted Botox is injected in multiple very small doses in the area treated. The theory here is that the effects of the Botox are more evenly spread over the areas treated and the chances of having areas over treated is less. The most notable area for this technique is in the forehead. The result of MicroBotox is a more natural look which is not frozen and the dosage of Botox is less. This technique has also been described for use in the neck by a Korean physician at a recent meeting. It was shown to mildly improve the neck wrinkles and improve the texture of the skin. For some people who have recalcitrant acne problems, MicroBotox (sometimes called “mesoBotox” when used in this situation) can be injected very superficially into the facial skin. However, there is a risk of affecting facial muscles and Revance’s RT001, a topical “Botox”, should be a better alternative to this technique.
In the near future, a cream to apply a substance similar to Botox will be FDA approved. Revance Therapeutics is developing RT001 for use in the lateral canthal rhytids (crows feet) and has shown great promise. It will be a cream which is applied in the physicians office and stays in place for about 15-30 minutes. This will eliminate injections for this area and is completely painless. The results seem to be impressive, possibly better than injections. The reason the results are better is similar to why MicroBotox is better for the forehead- the dosing seems to be more evenly applied to the muscles around the eyes. Other areas being tested by Revance are: underarm hyperhidrosis (sweating), migraines, and rhinitis (runny nose). Off label potential uses are for acne and general overall skin improvement of the face and neck. Unfortunately, the other areas which Botox is injected in, frown lines and forehead line, have muscles which are too deep to allow the topical ingredient to get to those depths. Whether or not the upper lip lines (smoker lines) will be treatable with RT001 has yet to be tested.
Even though Botox has been FDA approved since 2002 for cosmetic uses, there are still new techniques, new uses (approvals), and a new delivery model (topical) for a competitor which will soon get approval. The aesthetic industry is constantly changing and Dr. Weiner works hard to stay at the forefront of all the latest techniques and technologies. To learn more about Dr. Weiner, visit his website: http://www.theclinique.net For a consultation call: 850.622.1214. Dr. Weiner is a Facial Plastic Surgeon who devotes 100% of his practice to noninvasive and minimally invasive cosmetic procedures. His practice is called the Aesthetic Clinique and is located in Santa Rosa Beach, which is between Destin and Panama City Beach, Florida.
UPDATE: FDA APPROVED 4/29/2015, Now known as “Kybella”
UPDATE: KYTH Bought out by Allergan. Price of stock at time of original blog: 41.95, buyout price over 75
Kythera announced yesterday (9/16/2013) that they had 2 phase 3 studies for fat reduction in the submental area (underneath the chin) or “double chin” with just injections with their product ATX-101. The results were very positive, with 70% having one grade of change and 13.4% having 2 grades or more change. No serious side effects were noted. Minor side effects were discomfort and swelling which resolved. Another interesting positive outcome were the patient’s subjective scores on “happiness, self consciousness, feeling old, overweight, embarrassment, and being bothered” were all improved to the positive, several fold over the placebo. The results were sustainable as well with 90% still improved at 2 years and 80% sustaining benefits after 3 and 4 years.
Why is this a big deal? We can now destroy fat noninvasively with just injections. Granted, ATX-101 will probably only be useful for small areas of fat but it opens the door for off label use in areas other than the chin. Mesotherapy, multiple small injections to dissolve fat deposits, which has been done with non FDA approved products in the past, can now be somewhat legitimized with using FDA approved ATX-101, when and if it is approved. I suspect that ATX-101 will be approved in 2014 and late 2014 it will be in the hands of all the cosmetic physicians in the country. Soon there will be courses and experts, using the product all over the body for contouring. Heck, to have injections instead of liposuction, its a no brainer.
Another possible off label use for ATX-101 is for lipomas, benign fatty tumors, usually fairly superficial and slow growing. For those not wanting to have surgery and the scar that would follow, lipomas could be controlled with injections of ATX-101. Some people have multiple lipomas and the thought of having scars all over their body is not as attractive as getting injections to keep them “at bay” or make smaller.
There will still be a place for liposuction and Coolsculpting because the larger areas of fatty deposits won’t be treatable with ATX-101.
Looking for a good investment, buy KYTH. I suspect that this is quickly bought up by either Allergan (AGN) or Valeant (VRX) who both have cosmetic injectables (Botox, Restylane, Juvederm, Sculptra, Dysport) that would love to add this to their product lines.
The Aesthetic Clinique, and Dr. Steve Weiner, MD, Facial Plastic Surgeon, will be one of the first to have Kythera’s ATX-101 when it is FDA approved in 2014. For more information about Dr. Weiner and The Aesthetic Clinique, see http://www.theclinique.net
KYTH study results: http://www.kytherabiopharma.com/newsroom/
Dr. Steven Weiner is a Board Certified Facial Plastic Surgeon practicing in Santa Rosa Beach, Florida, between Destin and Panama City Beach, Florida. After laying down his scalpel in 2005 he has devoted his practice to Lasers and Injectables.