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With an anticipated FDA approval by the end of 2020, DAXI’s has the potential to be a true innovator among toxins featuring a stable proprietary peptide and long-lasting efficacy.
This is part 2 of a 4-part series
Part 1: The Cosmetic Toxin Pipeline
The U.S Food and Drug Administration (FDA) could approve DAXI for use in moderate-to-severe glabellar lines as early as November 2020, according to dermatologist Joely Kaufman, M.D., of Skin Associates of South Florida and the Skin Research Institute in Coral Gables, Fla.
Dr. Kaufman, principal investigator for Revance’s phase 3 SAKURA trials, says she’s excited about DAXI’s potential to be a true innovator among cosmetic toxins. DAXI is not entirely different than approved toxins, as it has the same active molecule, the 150 kilodalton toxin.
DAXI differs in that it has a nonhuman, nonanimal based proprietary peptide that adds to the toxin’s stability. The peptide prevents it from sticking to the surface of the bottle and prevents the molecules from sticking together, according to Dr. Kaufman.
“We’ve seen in clinical studies that people can expect longevity of around six month’s duration from DAXI,” she says.
In comparison, toxins on the market at their approved doses have three to four months duration.
“These additional peptides, while not an active ingredient, are helping the 150 kilodalton work better,” Dr. Kaufman says.
Many filler regimens are about twice a year. The twice-annual DAXI regimen, she says, could fit seamlessly, with patients having their fillers and toxins all in one visit.
There’s also more than seems to stand out about DAXI, she says. “I think it is the first toxin that’s going to look a little different to us clinically.”
SAKURA 3 trial data suggests 96% of patients injected with DAXI had a clinically measurable improvement of one or more grade changes in their glabellar lines four weeks post treatment.
According to Dr. Kaufman, that’s an impressive endpoint.
“DAXI is probably going to look a little stronger for some people when you inject it,” she says.
DAXI’s safety profile in phase 3 trials is similar to that of the approved toxins, and that’s for neurotoxin-naive patients, as well as those who have had Botox or other toxin injections.
Dr. Kaufman points out that while DAXI appears to last longer than toxins on the market, complications such as ptosis resolve as quickly as they do for approved toxins.
“As a treating physician, our biggest worry with a long acting toxin is that, ‘If this lasts longer, are my complications going to last longer also?’” she says. “The nice thing about our current toxins is in the rare instances that we inject somebody, and they get brow or eyelid ptosis, we know that it will not last nearly as long as the toxin. In the DAXI studies they also show that the ptosis rate and duration are the same as our current neuromodulator products.”
Providers would use DAXI as they use current toxins, by reconstituting it with saline. However, the units used will be different. Whereas clinicians use 20 units of Botox to treat glabellar lines, they’ll use 40 units of DAXI.
There’s something else that Dr. Kaufman noticed about glabellar line patients in the phase 3 SAKURA studies: “Patients were incredibly happy because they noticed some smoothing of their forehead lines. That is something very unique. It’s not really captured in the data but rather patient feedback.”
Aesthetic physicians will learn more as they gain experience with DAXI, Dr. Kaufman says.
“It will come through approved for glabellar lines and, of course, as physicians we’ll start using it in other places. So, we will need to be cognizant that there may be some slight clinical differences in a toxin that really seems to have much longer duration,” she says.
Revance is conducting a phase 2 open-label study looking at using the toxin to treat forehead lines and crows’ feet.
“It will be nice to see those studies so that when this reaches the market, we’ll have some more data available about how it behaves in other areas,” Dr. Kaufman says.
The potential place for DAXI in the cosmetic toxin market is huge, but it won’t be for everyone, she says.
“There are a lot of people who don’t want to come back every four months for Botox. But then there are also a lot of people who may want a weaker look to their toxin, where they don’t have quite as much weakness in the muscle,” she says. “DAXI botulinum toxin is a great choice for people who have already had Botox or Jeuveau and love the results but really don’t want to come every three to four months. I also see a place for DAXI in those patients with stronger muscles, like in men.”