FDA Accepts Resubmitted BLA for RelabotulinumtoxinA for Glabellar and Lateral Canthal Lines

On February 2, 2026, the U.S. Food and Drug Administration (FDA) accepted the resubmission of the Biologics License Application (BLA) for relabotulinumtoxinA for the temporary improvement of moderate-to-severe glabellar lines (frown lines) and lateral canthal lines (crow’s feet) in adults, signaling a potential new neuromodulator option in aesthetic dermatology.¹

This regulatory milestone follows a prior Complete Response Letter (CRL) that identified manufacturing-related deficiencies and reflects FDA acknowledgment that Galderma has addressed those chemistry, manufacturing, and control (CMC) issues.¹

The relabotulinumtoxinA submission is supported chiefly by the READY (RElabotulinumtoxin Aesthetic Development StudY) clinical program, a series of 4 phase III trials involving more than 1,900 participants evaluating efficacy and safety in moderate-to-severe facial dynamic rhytides.¹ The READY-1 trial, published in Aesthetic Surgery Journal, showed statistically significant improvements in glabellar line severity compared with placebo at 1 month with a favorable safety profile and persistent effects up to 6 months.¹

Trial Overview

READY-1 was a randomized, double-blind, placebo-controlled, phase 3 study enrolling approximately 297 adults with moderate-to-severe glabellar lines. RelabotulinumtoxinA demonstrated a significantly higher composite ≥2-grade improvement at 1 month versus placebo (82.9% vs 0%; P<.001), with investigator-reported none or mild severity in 96.3% versus 4.5% of patients (P<.001) and median duration of effect extending beyond 24 weeks.¹ Onset of action was observed by Day 1 in 39% of participants, and treatment-related adverse events (TEAEs) were low (3.6%) and predominantly mild.¹ Additional phase 3 READY trials (READY-2 for lateral canthal lines, READY-3 evaluating simultaneous treatment, and READY-4 assessing long-term safety) reported similar efficacy and durability results in company disclosures, albeit unpublished in peer-reviewed literature.^1-4
Key limitations in the current evidence base include the lack of published randomized data for lateral canthal lines comparable to READY-1’s glabellar results and the absence of large, independent comparative studies against other toxin formulations. Further, the generalizability of trial populations to broader clinical practice warrants evaluation, as aesthetic trial participants are often highly selected.

RelabotulinumtoxinA Overview

RelabotulinumtoxinA is a botulinum toxin type A neuromodulator engineered as a ready-to-use liquid using proprietary PEARL™ Technology, intended to preserve molecule integrity and facilitate consistent volumetric dosing without reconstitution.¹ This contrasts with lyophilized toxin products requiring reconstitution before injection. Botulinum toxins act by inhibiting presynaptic acetylcholine release at the neuromuscular junction, resulting in temporary muscle relaxation and attenuation of dynamic wrinkles.⁵

RelabotulinumtoxinA has received marketing authorization in more than 20 international markets, including the European Union, United Kingdom, Asia, and Australia for glabellar and lateral canthal lines, and continues regulatory submissions in additional jurisdictions.¹

Clinical Context

Dynamic facial rhytides such as glabellar and lateral canthal lines are common concerns in aesthetic practice, frequently treated with botulinum toxin type A formulations to reduce muscle-mediated creasing. OnabotulinumtoxinA (Botox) and abobotulinumtoxinA (Dysport) remain established options with extensive safety and efficacy data, supported by consensus guidelines.⁵ Treatment goals typically center on favorable wrinkle reduction with minimal downtime and low incidence of adverse effects such as eyelid ptosis or asymmetry.

Ready-to-use liquid formulations like relabotulinumtoxinA address practical considerations by eliminating the need for reconstitution, which can reduce preparation time and variability in dosing. However, head-to-head comparative data with established agents in terms of clinical efficacy, safety, and diffusion profiles remain limited in peer-reviewed publication.

References

1. Galderma announces U.S. FDA acceptance of RelabotulinumtoxinA BLA resubmission. News release. Galderma. February 2, 2026. https://www.galderma.com/news/galderma-us-fda-acceptance-relabotulinumtoxina-application

2. Shridharani SM, Moradi A, Donofrio L, et al. Efficacy and Safety of RelabotulinumtoxinA, a New Ready-to-Use Liquid Formulation Botulinum Toxin: Results From the READY-1 Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial in Glabellar Lines. Aesthetic Surgery Journal. 2024;44(12):1330-1340. doi: 10.1093/asj/sjae131

3. Galderma announces positive results in two phase III studies for RelabotulinumtoxinA. News release. Galderma. June 10, 2022. https://www.galderma.com/news/galderma-announces-positive-results-two-phase-iii-studies-novel-liquid-formulation

4. ASDS 2024: new phase III READY-4 data demonstrate long-term safety and efficacy. News release. Galderma. October 21, 2024. https://www.galderma.com/news/asds-2024-new-phase-iii-ready-4-data-demonstrate-long-term-safety-and-efficacy-galdermas (Galderma)

5. Bosslett M. Galderma Presents Phase 3 Relfydess Data and Dysport Innovations at TOXINS 2026. Article. Dermatology Times. January 23, 2026. https://www.dermatologytimes.com/view/galderma-presents-phase-3-relfydess-data-and-dysport-innovations-at-toxins-2026