- At least one dose in each study demonstrated a measurable treatment effect in 100% of subjects at 4 weeks, with median duration of 27 weeks in forehead lines and 24 weeks in crow’s feet -
- DaxibotulinumtoxinA for Injection was well tolerated across all doses in both indications -
In the forehead lines study, a total of 61 subjects were enrolled into one of four dose groups with each receiving 40 units of DaxibotulinumtoxinA for Injection in the glabellar complex, followed two weeks later by injections of either 12, 16, 24, or 30 units in the forehead for a total study duration of up to 38 weeks. In the crow’s feet study, a total of 63 patients were enrolled into one of four dose groups to receive either 12, 24, 36 or 48 units of DaxibotulinumtoxinA for Injection, then followed for up to 36 weeks.
The primary endpoint for efficacy was the proportion of subjects achieving a score of none or mild in wrinkle or line severity at Week 4 either at maximum eyebrow elevation for forehead lines or at maximum smile for crow’s feet. The scores were based on the investigator assessment. In the forehead lines study, 100% of subjects achieved a score of none or mild at Week 4 in at least one treatment group. In the crow’s feet study, 88% of subjects achieved a score of none or mild at Week 4 in at least one treatment group.
In addition, the proportion of subjects with a measurable treatment effect, as assessed by the investigator, was analyzed. A dose-dependent change in percent of subjects with at least a one-point change from baseline was observed. In both studies, 100% of subjects achieved a score of at least a one-point change from baseline at Week 4 in at least one treatment group.
One of the exploratory endpoints in these studies was duration of effect, defined as the median time to return to baseline wrinkle severity based on both investigator and patient assessment. At least one dose in each study demonstrated a median duration of effect of 27 weeks in the forehead lines study and 24 weeks in the crow’s feet study.
In these two Phase 2a studies, DaxibotulinumtoxinA for Injection was well-tolerated at all dose levels. Adverse events were mild, localized and transient as expected and there were no treatment-related serious adverse events, as is common with other approved neuromodulators in the treatment of upper facial lines. The most common treatment-emergent adverse events after forehead line treatment were edema (10%), erythema (6.7%) and headache (5%). There was a single occurrence of mild eyelid ptosis that was fully resolved by Day 9. The most common treatment-emergent adverse events after crow’s feet treatment were nasopharyngitis (11.1%), bruising (7.9%) and headache (7.9%). There were no events of ptosis.
Interim Week 4 data from these two Phase 2a studies were used in the final design of Revance’s current upper facial lines Phase 2 study (glabellar lines, forehead lines and lateral canthal lines), to optimize dosing and injection patterns. Revance is scheduled to report results from that study in the fourth quarter of 2020. The SAKURA Phase 3 program assessing DaxibotulinumtoxinA for Injection as a potential treatment for moderate to severe glabellar lines yielded positive results, and the subsequent submission for regulatory approval has been given a Prescription Drug User Fee Act (PDUFA) VI program date of
“We are very encouraged by the results of these two studies, designed to evaluate safety and efficacy, as well as identify safe and effective doses, for DaxibotulinumtoxinA for Injection in the treatment of forehead lines and crow’s feet,” said
Phase 2a Clinical Program in Forehead Lines
The company’s Phase 2a clinical program was a multicenter, open-label, dose escalation study to evaluate treatment of moderate or severe dynamic forehead lines (FHL) (frontalis) in conjunction with treatment of the glabellar complex. The study was conducted at four sites in
Phase 2a Clinical Program in Lateral Canthal Lines
The company’s Phase 2a clinical program was a multicenter, open-label, dose escalation study that evaluated treatment of moderate or severe lateral canthal lines (LCL) or crow’s feet. The study was conducted at three sites in
Additional information about each Phase 2a study can be found at www.clinicaltrials.gov.
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Jenifer Slaw, 347-971-0906
Nadine Tosk, 504-453-8344