MAY-JUN 2017

MedEsthetics—business education for medical practitioners—provides the latest noninvasive cosmetic procedures, treatment trends, product and equipment reviews, legal issues and medical aesthetics industry news.

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Page 38 of 67

In addition to the three currently available neuromodu- lators—Botox Cosmetic (Allergan), Dysport (Galderma) and Xeomin (Merz Aesthetics)—there are four more botulinum toxin type A (BtxA) products currently in Phase 2 and Phase 3 clinical trials. They include an injectable from Croma in Austria; Revance Therapeutics RT002; Evolus from Korea-based Daewoong Pharmaceuticals, which will be distributed in the U.S. by Alphaeon; and a new liquid toxin from Galderma. "This is one that I am looking for- ward to because it will be a premixed toxin," says Anthony J. Wilson, MD, a dermatologist with Richard L. Zeff, MD, PA, in Stratham, New Hampshire. "This could be very nice for practitioners because diluting the products takes time, and there is inconsistency and human error in mixing." For several years, Revance Therapeutics has been simultaneously working on two BtxAs: RT001, a topical formulation, and injectable RT002. After RT001 failed to reach its primary endpoints in Phase 3 trials, the company shifted its focus to RT002 as it reevaluates its topical pro- gram. "We are going back to our preclinical program with RT001 to understand what we can do better," says Abhay Joshi, chief operating offi cer at Revance. "Once we have a more complete understanding from the clinical data, we will come back and hopefully jumpstart the program down the road." RT001 and RT002's differentiating characteristic is the use of a proprietary peptide called TransMTS, which Revance believes will offer better longevity. "TransMTS is used in combination with our highly purifi ed neurotoxin," says Joshi. "It creates a complex ionic interaction between the toxin and the peptide that allows the product to be more stable and possibly impart increased duration." Results of the company's Phase 2 data is promising, notes Chicago-based plastic surgeon Steven Dayan, MD. "In the Belmont trials, it was a one-point improvement that showed a signifi cantly longer duration, so the data is not yet con- clusive but it is exciting," he says. "They are using a 40-unit dose to achieve that longer duration of four to six months. But is that 40-unit dose equivalent to 20 units of Botox? It's hard to say." Dr. Dayan posits that if Revance is able to achieve better longevity of results, other companies may respond with higher dose trials in an effort to meet the same duration of effect. In fact, this is already happening. Increasing Longevity John H. Joseph, MD, director of The Clinical Testing Cen- ter of Beverly Hills in California, published "Does Increasing the Dose of AbobotulinumtoxinA Impact the Duration of Effectiveness for the Treatment of Moderate to Severe Glabbelar Lines?" in the Journal of Drugs in Dermatology ( JDD) last December. He initiated the study based on his experience working with Dysport during its clinical trials. "In one particular trial, we were allowed to vary the dose based on the muscle mass," he says. "When we crunched the data, it clearly showed that as we increased the dose, duration also increased, and it was linear—it didn't plateau." For the JDD study, he and his coauthors doubled the recommended dose of Dysport, injecting 120 units into the glabella of patients with moderate and severe frown lines. With this dose, they were able to double the duration of the toxin. "The reason people are hesitant to use a larger dose is because they are fearful that the product will spread to the upper eyelids or into the upper forehead," says Dr. Joseph. | MAY/JUNE 2017 37

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