Neurotoxins to Watch

February 18, 2021
Lisette Hilton

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.

Part 1: 2021 Injectable Updates: Renewed Interest, Positive Stage 3 Trials, New Indications

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 to 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.

References

  1. Goldie K, Peeters W, Alghoul M, et al. Global consensus guidelines for the injection of diluted and hyperdiluted calcium hydroxylapatite for skin. Dermatol Surg. 2018;44(suppl 1):S32-S41. doi:10.1097/DSS.0000000000001685. Correction appears in Dermatol Surg. 2019;45(2):327.
  2. de Almeida AT, Figueredo V, da Cunha ALG, et al. Consensus recommendations for the use of hyperdiluted calcium hydroxyapatite (Radiesse) as a face and body biostimulatory agent. Plast Reconstr Surg Glob Open. 2019;7(3):e2160. doi:10.1097/GOX.0000000000002160
  3. Teoxane Laboratories with Revance Therapeutics, Inc., Exclusive U.S. Distribution Agreement for Dermal Fillers (press release). January 10, 2020. Accessed February 24, 2021. Teoxane Laboratories - Hyaluronic Acid news.
  4. Renuva®. http://mtf.trellist-dev.com/our-products/detail/renuva. Accessed February 25, 2021.
  5. Galderma receives FDA approval for restylane Defyne for chin augmentation. Galderma. https://www.galderma.com/news/galderma-receives-fda-approval-restylaner-defyne-chin-augmentation. Published February 4, 2021. Accessed February 25, 2021.
  6. Allergan aesthetics, an abbvie company, acquires innovative luminera dermal filler business. Cision PR Newswire. https://www.prnewswire.com/news-releases/allergan-aesthetics-an-abbvie-company-acquires-innovative-luminera-dermal-filler-business-301147404.html. Published October 7, 2020. Accessed February 25, 2021.
  7. Filler Technology. Neauvia. https://www.neauvia.com/fillers/fillers-technology/. Accessed February 25, 2021.
  8. BOTOX for the treatment of plstysma prominence. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03915067. Published April 16, 2019. Updated June 29, 2020. Accessed February 25, 2021.
  9. Safety and efficacy study of the simultaneous treatment of upper facial lines (horizontal forehead lines, glabellar frown lines and lateral canthal lines) in subjects with moderate to severe upper facial lines (ULTRA I). ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04594213. Published October 20, 2020. Updated February 23, 2021. Accessed February 25, 2021.
  10. Galderma announces phase 3 trials for liquid neurotoxin. MedEsthetics. https://www.medestheticsmag.com/news/news/21198355/galderma-announces-phase-3-trials-for-liquid-neurotoxin. Published October 19, 2020. Accessed February 25, 2021.
  11. Croma-pharma gmbh sets the course for entering the US market. Cision PR Newswire. https://www.prnewswire.co.uk/news-releases/croma-pharma-gmbh-sets-the-course-for-entering-the-us-market-692472411.html. Published September 5, 2018. Accessed February 25, 2021.
  12. Abbvie settles botox rival IP lawsuit with Evolus. BioSpace. https://www.biospace.com/article/abbvie-medytox-settle-intellectual-property-dispute-over-botox-rival/. Published February 19, 2021. Accessed February 25, 2021.