John Jesitus is a medical writer based in Westminster, CO.
Injectable aesthetic products recently FDA-approved or in late stages of development include polycaprolactone, a new hyaluronic acid and multiple neuromodulators.
San Diego – A common theme among new and possible future players in the U.S. injectable market is longer-lasting results, said an expert.
Among hyaluronic acid (HA) fillers, Teosyal (Teoxane) earned U.S. Food and Drug Administration (FDA) approval in late 2017. Hassan Galadari, M.D., said "It's a great HA filler, but different than all the other HAs. It tends to stretch and move well with the skin, so you can't really feel it once it's injected. It's excellent for dynamic lines, especially around the mouth." He is assistant professor of dermatology at the United Arab Emirates University.
Teosyal probably won't be available in the United States until late 2018 or early 2019, Dr. Galadari said. Along with finding a distributor, he said, Teoxane must strike a royalty agreement with Allergan because Allergan owns the patent to combining HA with lidocaine. This requirement, which applies to all Western markets, partly explains why it takes so long for new HA fillers to reach the U.S. market, he added.
Polycaprolactone (PCL), presently in phase 3 trials, will probably reach the U.S. market in about 2 years, Dr. Galadari said. "It's very exciting. To me, it's a much stronger biostimulatory filler than calcium hydroxylapatite (CaHa)." Because the collagen PCL produces is more stable, he said, PCL lasts longer than CaHa. According to Sinclair marketing, Ellansé S, M, L, and E last one year, 1.5 years, 3 years, and 4 or more years, respectively. Dr. Galadari said that in his experience, Ellanse S and M last about 6 months longer than Sinclair claims. Additionally, "Ellansé E is fantastic, especially if you're dealing with anatomical defects like HIV lipoatrophy."
Among neuromodulators, phase 3 results for RT002 (daxibotulinumtoxin A, Revance) show that the product lasts up to 27 weeks. If everything works out satisfactorily with remaining long-term RT002 trials, he said, the product probably will receive FDA approval by 2020. If that happens, "We will be seeing a new, longer lasting neurotoxin." Meanwhile, he said that Nabota (prabotulinumtoxin A, Daewoong) is awaiting FDA approval and will be marketed by Alpheon as Evolus the United States, probably by the end of 2018's third quarter.
Dr. Galadari also addressed myths regarding neuromodulators. Although Botox Cosmetic (Allergan) labeling advises physicians to use an entire vial within 4 hours of opening it, he said, research shows that when properly stored, contents of an opened vial last up to 6 weeks with no loss of efficacy or safety.
Likewise, "Any time we would reconstitute the material, we were afraid that if it started to foam or bubble inside, it would lose efficacy." But research shows that this is not the case, he said.
Dermatologists also have worried that performing repeated punctures of a sealed vial would introduce infection, Dr. Galadari added. "But as long as the seal is there, and you go through the rubber hub, it's completely fine." Negative pressure inside the vial prevents introduction of microorganisms, he said. "It won't lead to infections because you're not introducing infectious materials, given the fact that your needle should stay sterile."
Dr. Galadari has been a speaker for Allergan and Merz, an investigator for Aqtis, a speaker and faculty member for Sinclair Pharma and an investigator, speaker and faculty member for Teoxane.
U065 – “Up and Coming Fillers: Experience from Across the Atlantic.” Hassan I. Galadari, M.D. 5 p.m., Feb. 18. American Academy of Dermatology 2018 annual meeting.