The U.S. Food and Drug Administration (FDA) has accepted the resubmission of a Biologics License Application (BLA) for relabotulinumtoxinA (Relfydess), a next-generation neuromodulator under review for the temporary improvement of moderate-to-severe glabellar lines and lateral canthal lines — commonly known as frown lines and crow’s feet — in adult patients.
Data submitted in support of the application indicate that clinical effects may be observed as early as the first day after treatment, with improvements lasting for up to six months.
Revolutionizing Wrinkle Treatments
Pending FDA approval, relabotulinumtoxinA aims to revolutionize wrinkle treatments with rapid results and lasting effects. Developed as a ready-to-use liquid neuromodulator, relabotulinumtoxinA does not require reconstitution and is optimized for volumetric dosing.
This formulation is designed to simplify preparation, enhance ease of use, and support consistent dose and volume delivery. By eliminating the need for dilution, relabotulinumtoxinA may help reduce variability associated with reconstitution practices and streamline workflows in busy clinical settings.
The U.S. filing is supported by the READY (REelabotulinumtoxin Aesthetic Development StudY) clinical program, a large-scale, phase 3 development effort comprising four trials and enrolling more than 1,900 participants. RelabotulinumtoxinA was evaluated in adult patients with moderate-to-severe dynamic facial lines, including glabellar lines and crow’s feet. Results demonstrated a rapid onset profile and sustained efficacy. These attributes align with evolving patient and injector preferences for treatments that combine quick visible results with longer intervals between retreatments.
Outcomes were consistent across patients with moderate and severe baseline wrinkle severity, and in addition to aesthetic satisfaction, patient-reported outcomes indicated improvements in psychological well-being.
Additional data — including results from an in vivo head-to-head diffusion study comparing relabotulinumtoxinA with onabotulinumtoxinA in a rat model — were consistent with phase 3 data results. These data showed a favorable tolerability profile, low eyelid ptosis rates comparable to established neuromodulators, and no evidence of remote toxin spread.
Advanced Performance, Ease of Use
Pioneered by Galderma using its proprietary PEARL Technology (Precipitation, Extraction, and Activity-preserving Refined Liquid), relabotulinumtoxinA has already been approved in over 20 markets for the treatment of frown lines and crow’s feet. These include in the European Union, the United Kingdom, Asia, and Australia, with additional regulatory reviews ongoing worldwide.
Galderma has worked closely with the FDA to implement adjustments to its manufacturing process and is committed to using its expertise and heritage in the neuromodulator space to develop next-generation aesthetic solutions that address evolving needs.
“We pioneered the development of RelabotulinumtoxinA to address the growing demand for faster-acting and longer-lasting anti-wrinkle solutions,” said Baldo Scassellati Sforzolini, MD, PhD, global head of R&D at Galderma. “We’re excited about the potential to bring this innovative neuromodulator to the U.S., offering advanced performance and ease of use and building on our portfolio of neuromodulators that meets the full spectrum of injector and patient needs.”
Key Takeaways
- RelabotulinumtoxinA offers rapid onset with sustained effects lasting up to six months and is developed using PEARL Technology for molecule integrity preservation.
- The READY clinical program demonstrated relabotulinumtoxinA’s efficacy in improving moderate-to-severe facial lines, with consistent results across varying wrinkle severities.
- RelabotulinumtoxinA has received marketing authorization in over 20 countries, with ongoing regulatory submissions, aiming for a global presence.
- If approved in the U.S., relabotulinumtoxinA would enter a competitive neuromodulator market, addressing demand for faster-acting, longer-lasting solutions.
