Dr. William Coleman III, who spoke at the 2010 joint annual meeting of the American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery, said that two ultrasound-based fat reduction platforms currently being studied by the FDA have achieved circumferential fat reduction without surgery in clinical trials.

Dr. Coleman, a clinical investigator and member of the advisory board for UltraShape, said that the Contour ultrasonic fat reduction device developed by UltraShape can produce up to 7.6 cm of circumferential fat reduction.

“It is intended for reducing localized fat deposits mainly on the abdomen, flanks and thighs, and therefore is not a replacement for liposuction,” Dr. Coleman says of UltraShape’s Contour platform. “However, there are a number of clinical studies showing its efficacy in achieving significant circumferential fat reduction.”

Clinical studies of another ultrasound-based fat reduction device, LipoSonix by Medicis, have also purportedly shown a reduction in circumferential fat deposits by 2.8 cm on average.

A published clinical study also backs up efficacy claims of the new CoolSculpting fat reduction platform developed by Zeltiq, which uses cryolipolysis (fat-freezing) technology to permanently reduce fat cells. According to the study, a 25 percent gradual reduction in ultrasound-measured fat is seen six months after CoolSculpting treatment.

Other non-invasive devices utilizing light- and radiofrequency-based technology, as well as mesotherapy (injection lipolysis), have also explored as fat reduction modalities over the years, however as Dr. Coleman points out, these produce less-promising results and likely will not catch on, at least in their current stages of development.

“Mesotherapy will likely disappear unless it becomes safer and more reliable. Mechanical techniques and light-based devices have limited efficacy, and radiofrequency will have to be completely re-engineered to be successful in this market,” says Dr. Coleman.

Allergan argues that because their company has marketing exclusivity for Latisse until late 2011 and is further protected by patents that expire as far out as mid-2024, Apotex had no business filing an application with the FDA seeking approval to make and sell generic Latisse.

On the other side of the argument, Apotex maintains that while two Latisse-related patents are valid and enforceable, the third patent is irrelevant and would not prevent Apotex from forging ahead with a Latisse knock-off.  Apotex also alleges to have sent Allergan a letter in July 2010 explaining the company’s stance.

After Latisse launched its massive advertising campaign featuring Brooke Shields and now, Claire Danes, it didn’t take long for consumers to figure out that instead of using one Latisse applicator per upper eyelid each day as directed, they could get double the treatments (and spend half the money) by using one Latisse applicator on both upper eyelids each day.

Considering consumers’ conservative use of Latisse and the resulting lower-than-expected sales figures, Allergan’s move to protect its eyelash enhancement market share by suing Apotex over its plans to promote a Latisse copycat is no surprise.

In June 2010, Allergan lowered its full-year Latisse sales forecast to a range of $90 million to $100 million, down from a prior $140 million goal. A $40 million to $50 million profit decrease may not seem like much for a company that pulled in over $4.5 billion last year, $600 million of which was generated by Botox sales, but Allergan stands to lose twice as much if a generic Latisse product catches on.

While Botox is commonly used – and FDA approved – to treat wrinkles on the face and forehead, a wide range of other treatment applications have been successfully used.  Doctors have used Botox to treat hyperhidrosis, migraine headaches, and muscle spasms.

Last year, the FDA announced that Botox complications had been linked to off-label use, particularly in children treated for limb spasticity.  According to current U.S. law, doctors are permitted to administer medicine for whatever application they deem appropriate.  Doctors aren’t however, allowed to market medicine for any application they please.

The marketing restrictions on Botox have apparently hindered the pharmaceutical company’s ability to distribute safety information related to off-label use.  The lawsuit is intended to increase the physician’s ability to access safety information such as possible risks, benefits, dosing, patient selection, etc. and is in no way intended to increase sales of Botox.