Some differences between RT002 and other neurotoxins: RT002 combines Revance's proprietary botulinum toxin type A molecule, which is free of other proteins or animal-derived components, with the companyâs patented TransMTS peptide technology. The combination offers targeted delivery to intended treatment areas, while reducing potential spread beyond the injecting site, according to Revance.
Dr. Carruthers was principal investigator and presented the BELMONT phase 2 study findings at AAD. Researchers enrolled 268 subjects with moderate to severe glabellar lines and looked at three RT002 doses, 20U, 40U or 60U.
âDaxibotulinumtoxinA (RT002) is an intriguing neuromodulator because of its unique structure and its considerably longer effect. Because it has a unique âfurry overcoat,â namely, the TransMTS peptide technology, it seems to stay anchored in the location it was injected. It is believed this âanchoringâ generates the longer duration,â Dr. Carruthers tells Dermatology Times.
In the BELMONT study, according to Dr. Carruthers, there was no ptosis in the 20U and 40U groups, compared to a 1.9% incidence in the Botox 20U group and 7.5% incidence in the 60U daxibotulinumtoxinA group. There was no male ptosis with the 60U group, which may indicate that the male glabella can handle more units.
âThis, in itself, is a welcome safety aspect,â she says.
In addition, at week 24 of the study, 35.9% of the daxibotulinumtoxinA 40U group still had 1-point improvement on the global scale compared to 19% of the onabotulinumtoxinA group.
âAs we physicians have all known and respected onabotulinumtoxinA for its excellent effect on our patients for many years, it is a welcome and wonderful surprise to find another neuromodulator which exceeds our expectations of both safety and longevity of response,â Dr. Carruthers says.
If approved, it could be three to four years before RT002âs North American phase 3 trial and the FDAâs and Health Canadaâs considerations of those results, according to Dr. Carruthers.
Whether the new neurotoxin on the block will replace those on the market remains to be seen.
âIn our experience, patients become very loyal to the neuromodulator that has been giving them such excellent results over many years. I donât see daxibotulinum replacing currently approved neuromodulators, but rather expanding the aesthetic market, particularly for those patients looking for longer-lasting effects,â she says. âI think dermatologists will need to understand the mechanisms by which this new neuromodulator is able to provide enhanced safety and longevity for their patients. However, it should not be a steep learning curve.â
Joshua Zeichner, M.D., director of cosmetic and clinical research and assistant professor of dermatology at The Mount Sinai Hospital, New York, N.Y., says that while there are several different toxins currently available--each with slightly different characteristics including speed of onset, diffusion and duration of activity--a new toxin that offers patients a longer lasting effect would be a welcome addition.
â[RT002] demonstrated a longer duration of activity compared to currently available toxins, which in the real world would offer patients more convenience, with fewer visits to the office and fewer needle sticks,â Dr. Zeichner says.
Additional information about the trial can be found at www.clinicaltrials.gov, Clinical trial identifier NCT02303002.
Disclosures: Dr. Carruthers does research for and consults with Revance, Allergan, Merz, Alphaeon and Zeltiq. Dr. Zeichner reports no relevant disclosures.