Medical aesthetic company Evolus has launched its first botulinum toxin A product in Great Britain.
According to the company, Nuceiva (prabotulinumtoxin A) has been approved for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows. The safety and efficacy of the product was evaluated through the company’s Transparency programme.
A multicentre, randomised, double blind, placebo-controlled, single dose, phase III, non-inferiority study compared prabotulinumtoxin A and onabotulinumtoxin A for the treatment of moderate to severe glabellar lines in adult patients took place. In the 150-day study, 540 adult patients were enrolled. Patients were randomised to receive a single treatment (0.1ml injected into each of five glabellar sites) of 20U prabotulinumtoxin A, 20U onabotulinumtoxin A or placebo. Responder rates for the primary efficacy endpoint were 87.2% (prabotulinumtoxin A), 82.8% (onabotulinumtoxin A) and 4.2% (placebo). The difference between the two groups was 4.4%.
Patients’ level of satisfaction 30 days following injection showed that 91.5% (Nuceiva patients) were either satisfied or very satisfied compared to 86.5% (onabotulinumtoxin A patients) and 6.3% (placebo patients). No serious adverse events were assessed but the most frequently reported were headache and nasopharyngitis. The study therefore suggested that a single treatment of 20U prabotulinumtoxin A was shown to be safe and effective and non-inferior to 20U onabotulinumtoxin A.
David Moatazedi, president and CEO of Evolus, said, “We are excited to introduce Nuceiva to Great Britain, the single largest market for aesthetic neurotoxins in the European region, while we continue to finalise plans for entering additional countries as part of a phased rollout. Europe is the second largest market for aesthetic neurotoxins globally, and our expansion there will form the foundation for a potential future of aesthetic products.”
In the first half of 2023, the company plans to introduce the product to Germany and Austria and is working closely with its partner, Novvia Pharm, to achieve this. Evolus also expects to enter additional European countries, and, subject to regulatory approval, will also launch Nuceiva in Australia next year.
Evolus will be exhibiting at CCR on October 13-14 at ExCeL, London. Register for free here. The company have a masterclass taking place at the event as well as booth talks with aesthetic practitioners including Dr David Eccleston, Dr Vincent Wong, nurse prescriber Sharon Bennett, and nurses Samantha Berry and Brooke Carrero.
Evolus is partnering
with Wigmore Medical to supply Nuceiva in the UK.