The Year in Aesthetics
A look at some of the important developments and news from 2015.
The FDA approval of Kybella (deoxycholic acid injection) for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults was one of the most talked about aesthetic innovations of the year. In the pivotal Phase 3 studies, 68.2 percent of patients responded to Kybella based on a composite of validated physician and patient measurements. Patients treated with Kybella reported an improvement in the amount of fat in the area under the chin. The most common adverse reactions were associated with the injection site and included swelling, bruising, pain, numbness, erythema, and formation of small areas of firmness around the treatment area. The percentage of adverse reactions reported as mild were 81 percent, moderate 17.4 percent, and severe 1.6 percent.
Many patients experienced visible results in two to four treatments. Up to six treatments may be administered. Retreatment is not expected. After the FDA approval, Allergan acquired Kythera Biopharmaceuticals, Inc., adding Kybella to its portfolio.
Devices for Non-Invasive Body Shaping and Sculpting
Non-invasive options for liposculpting and body shaping continued to grow in 2015, particularly for smaller, more targeted areas than ever.
In September, the FDA granted an expanded clearance for Zeltiq Aesthetics, Inc.’s CoolSculpting procedure, and the company introduced the CoolMini applicator to treat smaller pockets of fat, including the submental area. The CoolMini applicator’s size, shape and curvature is designed to comfortably fit small, problem areas. Patients may see results as early as three weeks, with the most dramatic results generally observed one to three months following treatment. The FDA clearance was based on data from a US pivotal clinical trial involving 60 male and female patients, ranging in age from 22 to 65 years. In the trial, patients received one to two treatments in the area under the chin, each six weeks apart resulting in an average of 20 percent fat reduction, which is in line with results achieved with other CoolSculpting applicators. Additionally, no significant adverse events were observed and patients experienced little to no discomfort or downtime.
In June, BTL Industries received FDA clearance of its BTL Vanquish device for circumferential reduction of the abdomen area. Recently, BTL Aesthetics released the results of a new study that further demonstrates the superior results of BTL Vanquish in reducing stubborn fat around the midsection and effectively improving contouring of the abdomen and love handles. The study, conducted by Amir Morandi, MD and Melanie Palm, MD found that subjects experienced an average of 1.7-inch reduction in abdominal circumference following a controlled series of treatments with BTL Vanquish. This reduction was noteworthy as the results were similar to a previous study conducted of 40 participants with an overall higher BMI on average, demonstrating that the treatment is beneficial for a variety of body types, including those with lower BMI levels.
BTL Vanquish and Vanquish ME utilize patented, non-invasive and painless radiofrequency technology to reduce fat in the core and abdomen. The newly released BTL Vanquish ME is designed to treat the whole abdomen from flank to flank during one session for faster, smoother results.
Earlier this year, Cellfina from Ulthera, Inc. received FDA clearance for the long-term improvement in the appearance of cellulite on the buttocks and thighs with no loss of benefit for up to 2 years. Ulthera is a wholly-owned subsidiary of Merz, Inc. Cellfina is a minimally invasive procedure clinically proven to improve the appearance of cellulite for results that last at least two years, the longest duration cleared by the FDA. The Cellfina System combines proprietary technology with subcision, to treat the primary structural cause of cellulite. In a prospective, multicenter US clinical study, 55 patients underwent a single treatment. The Cellfina System improved the appearance of cellulite in 98 percent of treated patients at two years, according to independent physician evaluators. And, 96 percent of patients reported satisfaction with their treatment at the two-year mark, and noticeable improvement on the Global Aesthetic Improvement Scale was seen in 100 percent of treated patients at two years. Most adverse events were treatment site reactions such as bruising, soreness and hemosiderosis, which were usually mild to moderate and short in duration.
Cynosure, Inc. received 510(k) clearance from the FDA to market SculpSure for non-invasive lipolysis of the abdomen. Eariler this year, in May, the FDA cleared SculpSure for non-invasive lipolysis of the flanks. SculpSure is a safe, clinically proven treatment designed to reduce fat non-invasively by disrupting subcutaneous fat cells. The hands-free device features a flexible applicator system to treat multiple anatomical areas of the body.
Revance Therapeutics, Inc. continues to study its RT001 and RTOO2 neurotoxins with positive results and recently shared positive 24-week results from its multi-center BELMONT Phase 2 active comparator study of injectable RT002. The ongoing study for the treatment of glabellar lines in 268 subjects compared the safety, efficacy, and duration of effect of three doses of RT002 against placebo, and current market leader, BOTOX Cosmetic/VISTABEL. The topline interim data showed that RT002, a botulinum toxin type A investigational drug product candidate for injection, achieved its primary efficacy measurement for all three doses at four weeks. The study demonstrated 6-month RT002 median duration of effect based upon at least 1-point improvement in glabellar lines at maximum frown on the Investigator Global Assessment-Facial Wrinkle Severity (IGA-FWS) scale.
“With BELMONT, Revance has done something that has never been done before in a neurotoxin Phase 2 clinical program in terms of demonstrating superior duration of effect in an active comparator study. The 100 percent achievement of at least a 1-point improvement on the Facial Wrinkle Severity Scale seen as early as two weeks in all dose groups is impressive. The six month duration makes this a likely game changer in our aesthetic practices. Currently many of my patients come in year after year on a quarterly basis for botulinum toxin injections. With RT002 they could get their botulinum toxin treatments on a bi-annual basis, which conveniently coincides with a large percentage of my patients who receive fillers or other treatments for pan facial uses,” said Jean D. Carruthers, MD, Clinical Professor, at University of British Columbia, Medical Director at Jean Carruthers Cosmetic Surgery Inc., a lead investigator for the RT002 BELMONT trial.
The company has also commenced dosing patients in a Phase 3, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the safety and efficacy of RT001 (Botulinum Toxin Type A) Topical Gel, for the treatment of moderate to severe lateral canthal lines.
Earlier this year, Alphaeon Corporation began a Phase 3 study for its neurotoxin, Evosyal, a botulinum toxin type A neuromodulator, to treat glabellar lines.
Hair Removal Advances
Solta Medical, a division of Valeant Pharmaceuticals North America LLC, launched its Clear + Brilliant pelo laser for permanent hair reduction. The system uses a novel linear scanning approach with integrated contact cooling to deliver the effectiveness of current best-in-class diode laser hair removal technology with the fastest and largest treatment area available (50mm by 15mm).
Miramar Labs’ miraDry System received FDA clearance for the treatment of unwanted underarm hair, and permanent reduction of underarm hair of all colors. Miramar Lab’s proprietary miraWave technology—use of precisely controlled microwave energy—is the foundation of the miraDry System. With this clearance, the company introduced the miraSmooth treatment.
Alma Lasers added the Soprano ICE platform to its product portfolio this year. The Soprano ICE combines the high absorption benefits of the Alexandrite (755nm) wavelength with the advantages of a diode laser providing more comfort for the patient during hair removal and lower maintenance for the practitioner. This new multi-laser, multi-technology treatment approach allows practitioners to treat a wide range of hair types and colors. The Soprano ICE Multi-Platform offers several modules including Speed technology, allowing practitioners to perform more sessions in half the standard treatment time, the Compact applicator allowing for versatile treatment methods, the Facial TIP for treating small or hard to reach areas, and ICE proprietary advanced contact cooling technology. The Alma Soprano ICE also offers a 1064nm diode laser YAG technology handpiece for darker skin types.
Fillers for the Face and Beyond
Allergan received FDA approval to market Juvederm Ultra XC for injection into the lips and perioral area for lip augmentation in adults over the age of 21. In clinical trials of Juvederm Ultra XC, the majority of subjects reported improvement in the softness, smoothness, and natural look and feel of their lips through one year. In clinical trials, 79 percent of subjects showed a meaningful improvement in lip fullness three months after treatment. More than 78 percent of subjects reported an improvement in overall satisfaction with the look and feel of their lips one year after treatment.
Galderma launched Restylane Silk, FDA approved for lip enhancement and the treatment of wrinkles and lines around the mouth in people over the age of 21. In a clinical study involving 221 patients, investigators observed that 77 percent of patients treated with Restylane Silk showed an improvement in lip fullness eight weeks after treatment and 59 percent of treated patients maintained lip fullness six months after treatment, according to the company. In the same study, 98 percent of patients treated with Restylane Silk reported a visible improvement in the fullness of their lips 14 days after injection and 76 percent reported that they still had lip improvement at six months following injection. In the clinical study, the results of Restylane Silk lasted approximately six months following treatment.
Galderma also received FDA approval to market Restylane Lyft for cheek augmentation and for the correction of age-related midface contour deficiencies in patients over the age of 21. Restylane Lyft, formerly marketed as Perlane-L, is an injectable gel used to increase volume and smooth wrinkles in the face. With this new indication, Restylane Lyft is indicated to provide fullness to the midface area and to correct and smooth the nasolabial folds. In a clinical trial involving 200 patients, investigators observed that 88.7 percent of patients treated with Restylane Lyft showed an improvement in fullness in the right and left midface areas (combined) at two months, and more than half maintained improvement for 12 months. Additionally, 95 percent of patients reported improvement with the appearance of their midface at two months and 73 percent reported improvement at 12 months.
Radiesse from Merz Aesthetics received FDA approval for hand augmentation to correct volume loss in the dorsum of the hands. Radiesse provides an immediate volumizing effect and can help to reduce the prominence of tendons and veins in the hands, delivering smooth, natural-looking results that can last up to one year. In a randomized, controlled US trial, blinded evaluators reported that Radiesse improved the appearance of both hands in 75 percent of treated patients at three months. And, 98 percent of treated patients also reported improvement in the appearance of their hands at three months. Improved aesthetic outcomes as measured on the Global Aesthetic Improvement Scale after initial and repeat treatments correlating with clinical improvement were demonstrated in this study, with all primary and secondary endpoints being met.
Merz also received FDA clearance for Radiesse (+) with integral 0.3% Lidocaine (Radiesse Plus). Radiesse (+) provides the immediate lift of wrinkles and folds, stimulation of natural collagen production, and the lasting results that patients and physicians expect from Radiesse, as well as providing patients significant reduction in pain due to the addition of lidocaine. Radiesse (+) is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Radiesse (+) is a robust filler providing high elasticity (G’) and viscosity.
The FDA granted approval for Suneva Medical Inc.’s Bellafill to treat acne scars based on the outcomes of a double-blinded, randomized, placebo-controlled pivotal study. Bellafill was found to be a safe and effective treatment when compared to subjects treated with a Control saline injection.
Suneva also released the results of five-year satisfaction outcomes of Bellafill. Billed as the largest and longest post-market clinical evaluation of a dermal filler, the study found high levels of patient satisfaction and favorable safety outcomes with Bellafill five years post-treatment. The study enrolled 1,008 patients at 23 US study centers. Patients were treated to optimal correction (allowing for touch-up injections, if needed) then followed for five years after the last injection. In all, 83 percent of subjects were “satisfied” to “very satisfied” with outcomes with their Bellafill treatment at the conclusion of the five year study. No treatment-related serious adverse events or unanticipated adverse events were noted.
Syneron Medical Ltd. introduced the PicoWay Resolve, a dual wavelength fractional modality for the PicoWay picosecond laser. PicoWay utilizes proprietary PicoWay technology to generate picosecond pulses for the treatment of pigmented lesions and tattoos, including recalcitrant tattoos. Resolve employs a holographic fractionator to deliver precisely consistent energy to the entire treatment area, which results in pristine, reproducible results. Resolve’s two wavelengths enable treatment of shallow lesions with the 532nm wavelength, while the 1064nm wavelength is used for deeper lesions and to treat all skin types, with no downtime.
DEKA M.E.L.A received additional FDA clearance for its Synchro REPLA:Y family of Laser Systems, allowing for Maximum Power of 180W and a 24mm spot size. The Synchro REPLA:Y family of Laser Systems consists of three aesthetic workstations. Each station is designed and mainly dedicated to offer high-speed, stable long-term, or permanent hair reduction, and treatment of pseudo folliculitis barbae. Additionally, the Synchro REPLA:Y family of Laser Systems offers high-speed, effective, and safe treatment of benign pigmented lesions, wrinkles, and photocoagulation of dermatological vascular lesions.
Alma Lasers introduced the Harmony XL Pro platform, which consists of multiple modules for six indications: skin remodeling, vascular lesions, pigmented lesions, tone and texture, hair removal, and acne. Each may be treated using a single technology or a combination of technologies and treatment approaches to achieve clinical results. The modules are designed to work independently or together as a single cohesive, harmonious system.
Lumenis Ltd. launched its ResurFX laser system for fractional non-ablative skin resurfacting treatments. This new ResurFX system is a stand-alone desktop solution, which builds upon the successful launch of ResurFX module for the M22 multi-application platform.
Cynosure, Inc. received FDA 510(k) clearance of its new 532nm Laser Delivery System for PicoSure, creating a dual-wavelength laser system for removing tattoos of all colors in fewer treatments. n