FDA Sets November PDUFA Date for DaxibotulinumtoxinA from Revance image

Revance Therapeutics, Inc. will begin introducing the RHA Collection of dermal fillers, Resilient Hyaluronic Acid, and the HintMD financial technology platform, in the United States in September.

The RHA Collection of dermal fillers are designed with a crosslinking method that preserves the hyaluronic acid network to more closely mimic natural HA found in the skin. 

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 same commercial infrastructure is anticipated to roll out DaxibotulinumtoxinA for Injection for the treatment of glabellar lines upon FDA approval later this year. 

“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,” says Dustin S. Sjuts, Chief Commercial Officer, in a news release. “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, along with our lead investigational candidate DaxibotulinumtoxinA for Injection’s anticipated approval just around the corner.” 

In an 18-month, head-to-head, randomized and controlled study in Dermatologic Surgery, RHA 2, 3, 4 were evaluated for efficacy, durability and safety versus other available comparator gels on the market for the treatment of nasolabial folds. Results showed: 

  • 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 nasolabial folds volume with gels in the RHA Collection based on 3D skin topography measurements. 

In the European Clinical Experience and Tissue Integration Analysis published in Journal of Drugs in Dermatology, observations from clinical experience 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. 

In 2017, the FDA approved the RHA Collection based on data from two U.S. studies, each a 15-month, prospective, multicenter, active-controlled, randomized, double-blinded, split-face clinical trial. Results included:

  • More than 90 percent of patients were satisfied or very satisfied with their results 12 months after treatment
  • Sustained clinical effectiveness, with more than 80 percent 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 U.S. clinical trials with RHA® 2, RHA® 3, and RHA® 4 were injection site firmness, lumps/bumps, tenderness and injection site swelling.