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Clinical results of new neurotoxin reveal potential long-term aesthetic effects

Clinical results of new neurotoxin reveal potential long-term aesthetic effects
The biotechnology company Revance Therapeutics, Inc. (Newark, California) recently published the results of two pivotal trials of the candidate neurotoxin drug DaxibotulinumtoxinA for injection (RT002), intended for the treatment of moderate to severe glabellar lines in adults. Based on the results of this study, Revance has announced that it is awaiting US FDA approval in 2019 and European approval in 2021.

As revealed by results of the study, RT002 incorporates the exclusive TransMTS ® product of Revance, an experimental injectable formulation designed to limit daxibotulinumtoxinA to the target site.

When the toxin-bound TransMTS peptides enter the muscle, they exert a focused effect on the injection site, thereby reducing the undesirable spread of the toxic substance and potentially allowing a longer duration. RT002 peptide technology has generated positive results in the recently completed SAKURA 3 long-term open safety study.

The SAKURA-3 study involved 2,700 patients and 3,800 injections. The results of this test indicate that RT002, which will bear its own brand name before agency approval, will be very different from other neurotoxin-based cosmetic products currently on the market. Incidentally, the company feels very confident about RT002 and has already presented it as a longer-lasting neurotoxin treatment that can lead to a dosage of up to six months and possibly longer. The next milestone for Revance will be to complete studies in 2019 on the use of RT002 in the forehead and lateral canthus lines, as well as its use and dosage in the upper part of the face. This latest trial will use what is apparently the largest database ever created for a study on neurotoxins, with nearly 3,000 patients on multiple treatments. Revance is expected to publish the results of these studies in the first half of 2019, then file an application for a license for organic products (BLA).

According to company executives, the neurotoxin market, dominated by Allergan’s Botox Cosmetic, could benefit from a product with a long-lasting effect.

According to a recent survey conducted by The Harris Poll of more than 2,000 women, wrinkles and facial features are the most worrying visible sign of aging in women aged 25 to 70 years. The survey also took into account the observations and opinions of nearly 250 dermatologists and plastic surgeons who see at least 15 patients per week who are receiving neurotoxin treatment. Among this group of doctors, a large majority declared that they wanted a neurotoxin-based product offering more lasting results than those currently available.

Throughout 2019, Revance will also actively pursue studies that are expected to generate approvals in Europe and Asia, as well as in Latin America, primarily Brazil and Argentina. The company’s aggressive development program would add another territory every two quarters.

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