SAN DIEGO – In the coming years, expect to see an increasing number of neuromodulators hit the market, Joel L. Cohen, MD, predicted at the annual Masters of Aesthetics Symposium.
Dr. Joel L. Cohen
One such product, DaxibotulinumtoxinA (Daxi), formerly known as RT002, contains a proprietary peptide that may contribute to extending its duration of action beyond currently available neuromodulator products. “Another difference for Daxi is that it does not contain human serum albumin,” said Dr. Cohen, who’s in private practice in Greenwood Village and Lone Tree, both in Colo.
In trials of the agent conducted by Revance, the manufacturer, for the treatment of moderate to severe glabellar lines, DaxibotulinumtoxinA achieved a 1-point change in results from baseline in a median of 24 weeks, while the return to baseline wrinkle severity occurred in a median of 28 weeks. According to the Revance web site, DaxibotulinumtoxinA is up for possible Food and Drug Administration approval in 2020.
Though current neuromodulators on the market may be most effective for 3-4 months, the reality is that patients often don’t come in for longer stretches of time – as there is still some degree of efficacy. Dr. Cohen shared interim data from an ongoing study that showed that at 6 months 69% of patients remain satisfied with the result of their last injection. “With Dysport, for example, even though we know the durability is to 3-4 months, we have patients who may still be happy with the results at 6 months,” he said.
Another trend he discussed is the increasing interest in QM1114, a novel, ready-to-use type A botulinum toxin formulation being developed by Galderma for the aesthetic treatment of glabellar lines. Unlike Botox, Dysport, Xeomin, and Jueveau, QM1114 is a liquid and thus does not require reconstitution.
“Myobloc is also a liquid but it is a type B botulinum toxin,” Dr. Cohen said. “It’s always been formulated as a liquid toxin, but it’s not something we can use commonly in our aesthetic practices [unless a patient is suspected of having extremely rare type A antibodies] for many reasons beyond simply it not being approved for aesthetic use. Though Myobloc kicks in faster, it spreads more, it hurts more, and it doesn’t last as long.”
In a phase 2 study presented at the 2019 World Congress of Dermatology, investigators, including Dr. Cohen, evaluated the safety and efficacy of QM1114 for the treatment of glabellar lines in 359 patients aged 23-79 years. Patients were randomly assigned to one of three single-treatment groups – 35 units, 45 units, or 60 units – or to placebo. Two weeks post treatment, wrinkle severity improved by at least two grades based on the assessment of investigators (a range from 83%-91%) and by that of treated subjects (a range from 73%-86%), compared with 6% and 8%, respectively, in the placebo group. In addition, 90%-98% of subjects rated themselves as “very satisfied” or “satisfied” with the treatment at month 1, compared with 72%-80% of subjects at month 6. Treatment-related adverse events occurred in little more than 1% of subjects in any QM1114 group and presented as mild to moderate injection-site pain, headache, eyelid ptosis, injection-site pruritus, injection-site swelling, and eyelid edema.
Dr. Cohen reported having research and financial ties to numerous pharmaceutical and device companies including Merz, Galderma, Allergan, Revance, Evolus, and Croma.