Revance Therapeutics Inc has established its field force and will begin introducing its aesthetics portfolio, including the RHA Collection of dermal fillers, hyaluronic acid, and the HintMD financial technology (fintech) platform, in the United States in September, it announces.
Revance Commercial Launch
After completing the onboarding and training processes for its 100+ field force team, the company plans to approach prestige aesthetic practices across the US, offering its first premium products and services, the RHA Collection of dermal fillers, along with an integrated fintech platform, HintMD. The same commercial infrastructure is anticipated to roll out DaxibotulinumtoxinA for Injection for the treatment of glabellar lines upon FDA approval later this year.
Revance has recently concluded the RHA Collection PrevU early clinical experience education and training program for select practices ahead of the consumer launch of the RHA Collection and plans to share observations in the near future, the company explains in a media release.
“Revance is positioned to re-energize the aesthetics industry with the creation of a prestige category of innovative products and services and elevated customer and patient experiences available through select practices. Our commercial team, comprised of industry experts with decades of aesthetics and commercial experience, is now trained and in position to execute Revance’s first commercial launch.
“We are delighted to be entering the market with the RHA Collection, the latest innovation in HA technology, and an integrated fintech platform designed to transform existing payment processing ecosystems and improve both aesthetics practice economics and patient experiences. We plan to follow with our lead investigational candidate DaxibotulinumtoxinA for Injection after its anticipated approval, which is just around the corner.”
— Dustin S. Sjuts, Chief Commercial Officer
18-Month Head-to Head European Clinical Study
In an 18-month, head-to-head, randomized and controlled study published in Dermatologic Surgery, RHA 2, 3, and 4 were evaluated for efficacy, durability and safety versus other available comparator gels on the market for the treatment of nasolabial folds (NLF). Results suggest:
- Overall physician preference for RHA Collection products due to ease of injection and product placement, immediate results, and results after massage of the injected tissue
- High levels of improved satisfaction immediately after injection and in the long-term for both investigators and participating subjects
- Fewer touch-ups were needed by (or at) day 14 with gels in the RHA Collection (26.7% versus 35.6% with comparators)
- Better long-term improvement of NLF volume with gels in the RHA Collection based on 3D skin topography measurements.
European Clinical Experience and Tissue Integration
Observations from clinical experience, published in Journal of Drugs in Dermatology, included:
- RHA fillers blend well into wrinkles and folds with excellent tissue integration
- RHA 2 and RHA 3 fillers could be used effectively in the superficial and mid-dermis for the treatment of perioral and marionette lines
- RHA 4 filler, when used for volumizing, injected very easily and, during the follow-up period, the treated areas remained supple and treatment results natural looking.
US FDA Approval Supported by Two 15-Month Studies
In 2017, the FDA approved the RHA Collection based on data from two US studies, each a 15-month, prospective, multicenter, active-controlled, randomized, double-blinded, split-face clinical trial, published in Dermatologic Surgery and the Journal of Cosmetic Dermatology. Results suggest:
- More than 90% of patients were satisfied or very satisfied with their results 12 months after treatment
- Sustained clinical effectiveness, with over 80% of patients still maintaining a clinically meaningful response at 15 months
- Favorable long-term safety profile, with no delayed-onset adverse events reported.
The most frequent treatment-related adverse events reported in the US clinical trials with RHA 2, RHA 3, and RHA 4 were injection site firmness: 27.8%, 25.3%, 37.5%; lumps/bumps: 20.8%, 27.7%, 37.5%; tenderness: 9.7%, 13.3%, 15.8%; and injection site swelling reported in 8.3%, 12.0% and 19.2% of patients, respectively.
For more information, visit Revance Therapeutics Inc.
[Source(s): Revance Therapeutics Inc, Business Wire]
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