- 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.
TREATMENT EFFECT
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.
SAFETY
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.
ADJACENT STUDIES
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
Added
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.
About
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Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates; our ability to obtain funding for our operations; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; our ability to successfully commercialize our drug product candidates and the timing of commercialization activities; the rate and degree of market acceptance of our drug product candidates; our ability to develop sales and marketing capabilities; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in Revance's periodic filings with the
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