News & Trends

Juvéderm Voluma XC Approval Sets New Mark for Cosmetic Injectables

Allergan's Juvéderm Voluma XC became the first injectable filler indicated to temporarily correct age-related volume loss in the cheek area in adults over the age of 21 when FDA granted approval in October. According to Vic Narurkar, MD, a clinical investigator on the Voluma trials, the approval represents a major step forward in the world of aesthetic injectable treatments for a number of reasons. “In the past we've looked at fillers more from the standpoint of filling in the lines, starting with collagen-based fillers and eventually hyaluronic acids.” Over the last several years, however, injectors and researchers have increasingly looked at fillers in terms of replacing volume, observes Dr. Narurkar. “As we age, we lose volume, and we see that most pronounced in the mid-facial cheek area. If you look at a youthful face, one of the first things you notice is the volume of the cheek bone area,” says Dr. Narurkar.

Physicians have utilized filling agents to volumize the midfacial area for years. According to Modern Aesthetics co-chief editor Heidi Waldorf, MD, “The best injectors won't need to learn a new technique to use this product.” Rather, she says, “the significance of this approval is that there is now a product on the market with an on-label approval for volumizing the central face. We've been doing that for years with other fillers off-label, but now the discussion can be brought directly to the consumer from Allergan in reference to Voluma,” says Dr. Waldorf. “Hopefully, that will take some of the discussion away from the ‘parentheses' that patients always want filled and aid our discussion of reshaping and replenishing lost volume and structure for rejuvenation, rather than just filling lines,” Dr. Waldorf observes.

In the trial that led to its approval, Juvéderm Voluma XC yielded efficacious and durable results, with patients' midfacial areas experiencing volumization for up to a year. That is due to an advanced manufacturing process—known as VYCROSS technology—that results in a smooth gel that flows easily and consistently. “We have learned very recently that the ability of a product to lift and volumize aspects of the tissue is much more complex,” says Dr. Narurkar. VYCROSS technology also contributes to the noted duration of results that Juvéderm Voluma offers patients. The only other approved long-lasting filler, Sculptra (Valeant) requires multiple injections and is not specifically FDA-approved for the mid-face area. “Whereas other fillers require multiple injections to maintain results, a single injection of Voluma can offer results of up to two years,” says Dr. Narurkar.

While the approval of Voluma is likely to establish a new plateau in aesthetic injectables, clinicians should take note that with a brand new agent comes a learning curve. “Unfortunately there will be those practitioners who don't understand the appropriate way to volumize and will simply start over-plumping cheeks, as many of them did with nasolabial folds and before that the lips,” says Dr. Waldorf. At the recent Cosmetic Surgery Forum held in Las Vegas in December, Vivian Bucay, MD stressed the importance of learning about Voluma's new and unique properties for lifting and volumizing. “By educating ourselves and our patients on the strategic placement of volume, we will be able to impact other areas of the face, as well,” Dr. Bucay noted. Moreover, Dr. Narurkar believes that Juvéderm Voluma will challenge physicians to continue learning about the utility of fillers, specifically when it comes to the developing concept of layering. “As we learn to place some products more deeply, others moderately, and others superficially, the availability of a complex volumizing agent such as this will set forth a whole new approach and open up new concepts and pathways for mid-face volumization,” says Dr. Narurkar.

KYTHERA Reports Positive Phase III Trial Results for ATX-101

ATX-101, Kythera Biopharmaceuticals, Inc.'s injectable drug in clinical development for the reduction of submental fat, or “double chin,” met all primary and secondary endpoints in two Phase III trials, and Kythera says it is preparing for FDA submission. The data, announced this fall and presented at the ASDS Annual Meeting, show that in addition to a visible reduction in submental fat, treatment with ATX-101 was also associated with high levels of patient satisfaction, notes Frederick Beddingfield, III, MD, PhD, Chief Medical Officer of Kythera.

Findings come from the REFINE-1 and REFINE-2 Phase III trials for ATX-101, a proprietary injectable formulation of a purified synthetic version of deoxycholic acid. Deoxycholic acid is a naturally occurring molecule in the body that aids in the breakdown of dietary fat. The trials, conducted in the US and Canada, compared the efficacy and safety of a 2mg/ cm2 dose of ATX-101 versus placebo for the reduction of submental fat.

The identical multicenter, double-blind, randomized, placebo- controlled trials enrolled more than 1,000 subjects with moderate to severe submental fat. Based on validated rating scales used to evaluate primary efficacy endpoints at 12 weeks, active treatment with ATX-101 produced at least a one-grade improvement in both clinician and patient ratings in 70.3 percent (REFINE-1) and 66.9 percent (REFINE-2) of subjects, versus 18.7 percent and 22.4 percent of controls, respectively. Dr. Beddingfield points out that, in addition to these strong results, analysis also showed that 13.4 percent of treated subjects in REFINE-1 and 18.7 percent of subjects in REFINE-2 had an improvement of at least two grades on both clinician and patient rating scales, versus 0 percent and 3.2 percent of controls, respectively.

In addition to clinician and patient ratings, MRI analysis was used to quantify the change in volume of the submental regions of subjects as a secondary endpoint. Findings were consistent, Dr. Beddingfield observes, showing 46.6 (REFINE-1) and 40 percent (REFINE-2) of patients achieved a predefined, statistically significant reduction in volume for active treatment, respectively in each study, compared to 5.4 and 5.1 percent reductions for controls.

Patient-Reported Submental Fat Impact Scale (PR-SMFIS, a secondary endpoint) scores showed that treated subjects were statistically significantly more likely to perceive themselves to be happier, less bothered, less self-conscious, less embarrassed, younger or less overweight after treatment with ATX-101.

According to Dr. Beddingfield, who, in addition to his role at Kythera is a practicing dermatologist at the UCLA School of Medicine where he is an Assistant Clinical Professor in the Division of Dermatology, “We know that the submental area is visually important to patients but is undertreated. Currently, there is no FDA-approved injectable available to treat the submental region. If approved, ATX-101 could offer aesthetic physicians a nonsurgical intervention that reduces the fat under the chin while also delivering high patient satisfaction.”

ATX-101 acts by destroying fat cells,” he adds. Based on earlier clinical data this is predicted to provide a long lasting effect. In fact, Dr. Beddingfield says, data show that 90 percent of treated patients are still responders at two years with more than 80 percent of patients sustaining benefits after three and four years.

Adverse events associated with ATX-101 treatment tend to be transient, local to the treatment area and mild to moderate in severity, and include swelling, bruising, pain, numbness and redness. Less than four percent of study subjects discontinued the studies due to adverse events. While patients should be made aware of these potential side effects, the low discontinuation rate and high satisfaction suggests skilled dermatologists are able to manage these effects in conjunction with patients when they occur.

Feeling at least six years younger than their chronological age, on average, American women are more open to cosmetic surgery than ever before, new data reveal. The American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS) surveyed approximately 500 women ages 45 to 60 about the changing face of 50.

In all, 69 percent of respondents reported feeling at least six years younger than their chronological age and said when it comes to reversing signs of aging, they want a natural result and want to be the best, most youthful, and attractive version of themselves they can be, without looking too different.

Of the women surveyed, 70 percent stated that a milestone birthday did impact the way they feel about their appearance. The survey revealed that women are more open than ever to both surgical and non-surgical treatments to slow down the visible signs of aging, highlighting the biggest concerns and the most common interventions (See figure above) that the women have tried.

Research Briefs

Warning: Medical Tourism Complicating Aesthetic Care

As cosmetic medical tourism continues to increase, so may the number of complications that present to aesthetic physicians in the US, a new report warns. Unfortunately, patients who receive cosmetic injectables overseas may not know what agents were used—whether approved for use or not—further complicating management.

Writing in the December issue of The American Journal of Cosmetic Surgery, researchers reported on the case of a 52-year-old woman who presented with delayed-onset nodules in the malar and glabellar regions approximately 16 months after undergoing facial augmentation via injection of an unknown substance in China. The team was able to use computed tomography (CT) of the head with three-dimensional reformatting to characterize the nature and extent of the interventions performed. A cycle of treatment involving injection of lidocaine, triamcinolone, and fluorouracil into the affected areas accompanied by interspersed daily massage, resolved the nodules. The authors suspect that the injected material was a form of silicone. In addition to producing delayed onset reactions, injected silicone can also complicate subsequent cosmetic procedures, such as CO2 laser resurfacing, which can result in scarring.

—The American Journal of Cosmetic Surgery.
2013 Dec. 30(4):235-238

Valeant Pharmaceuticals to Acquire Solta Medical

Valeant Pharmaceuticals International, Inc. has entered into a definitive agreement to acquire all of the outstanding common stock of Solta Medical, Inc. for $2.92 per share in cash, a 40% premium to Solta's closing share price on December 13, 2013, the last trading day prior to announcement.

The transaction—valued at approximately $250 million— is expected to close in the first quarter of 2014. Valeant expects the transaction, once completed, to be immediately accretive to Valeant's cash earnings per share. Under the agreement, Valeant will commence a tender offer for all outstanding shares of Solta at a price of $2.92 per share in cash. The tender offer will be conditioned on the tender of a majority of Solta's shares calculated on a diluted basis, as well as the receipt of regulatory approval and other closing conditions. Following the completion of the tender offer, a wholly owned subsidiary of Valeant will merge with Solta and the outstanding Solta shares not tendered in the offer will be converted into the right to receive the same $2.92 per share in cash paid in the tender offer.

Solta designs, develops, manufactures, and markets energy- based medical device systems for aesthetic applications. Solta's products include the Thermage CPT system, the Fraxel repair system, the Clear + Brilliant system, and the Liposonix system. Solta had total revenue of approximately $145 million in 2012.

FDA Approves Varithena to Treat Varicose Veins

The FDA approved Varithena (polidocanol injectable foam, BTG plc) to treat patients with incompetent veins and visible varicosities of the great saphenous vein (GSV) system.

Varithena (formerly known as Varisolve PEM) is a pharmaceutical- grade, low-nitrogen, polidocanol foam dispensed from a proprietary canister device. In two pivotal, placebocontrolled Phase III trials, VANISH-1 and VANISH-2, Varithena achieved a clinically meaningful improvement in the symptoms of superficial venous incompetence and the appearance of visible varicosities and addressed the underlying venous incompetence in the majority of patients treated, according to the company.

Varithena provides the only FDA-approved comprehensive therapy to improve symptoms and appearance of varicose veins, including incompetent GSV, accessory saphenous veins, and visible varicosities of the GSV system above and below the knee. Treatment does not requires tumescent anesthesia or sedation.

Louise Makin, CEO at BTG, said, “We are delighted to receive US approval for Varithena, which we believe sets a new standard for the treatment of both the symptoms and appearance of varicose veins. We look forward to the commercial US launch in the second quarter of 2014, and to continuing to advance our plans to expand use into other geographies and into non-symptomatic veins.”