Physicians discuss 2021 neurotoxin FDA-approvals, phase 3 trials, new indications, and introductions into the U.S. market.
This is part two of a two-part series.
Allergan, of Botox Cosmetic fame, is in late-stage studies looking at different possible indications for the neuromodulator, including for the platysma and masseter muscles.8,9 The company is studying microinjections into the skin, as well as using a higher dose Botox for longer duration of effect, he says.
Galderma is conducting studies on Dysport (abobotulinumtoxinA) looking at increased longevity and patient satisfaction. The company’s QM1114 (relabotulinumtoxinA), a ready-to-use liquid botulinum toxin, is in phase 3 trials for treatment of glabellar lines and lateral canthal lines, according to Gold.10
Xeomin from Merz is being studied for use in the full upper face, as well as in high-dose trials.11
“All are doing well. We just have to wait for the final results,” Gold says. “Xeomin looked at 50, 75, and 100 units in the glabella. They’ve already reported up to 75 units doing really well for a long time.”
Hugel, a South Korean company, may soon have its botulinum toxin type A (Botulax) available in the US. market.12
The pivotal neuromodulator approval, however, is Revance’s Daxi (daxibotulinumtoxinA).
“Daxi is presumed to get approval later this year on a longer duration than we’ve had so far,” says Gold. “They tell us they have an excipient protein as part of the molecule that may be leading to that longer duration. We will see how that plays out in the real world. The biggest issue with all the toxins is price. If Daxi comes out priced wrong, they are not going to be as successful as if priced right.”
Evolus’s Jeuveau (prabotulinumtoxinA-xvfs) continues to fight legal troubles from an Allergan-based patent infringement lawsuit. 13
“Right now, they’re moving along as normal but there’s a lot of work behind the scenes of trying maintain product availability,” says Gold.
Disclosures: Biesman is a consultant and researcher for Allergan, Galderma, Merz, and Revance. Gold is a consultant for Allergan, Merz, and MTF.