IRVINE, Calif., Feb. 17, 2018 /PRNewswire/ -- Evolus, Inc.
(NASDAQ: EOLS) today announced the presentation of data from the
Phase III comparative clinical trial of its investigational
prabotulinumtoxinA 900 kilodalton (kDa) neuromodulator at the
American Academy of Dermatology (AAD) meeting.
The European and Canadian Phase III study, EVB-003, was
presented by Berthold Rzany, M.D
during the AAD meeting on Saturday, February
17, 2018. In the study, prabotulinumtoxinA and
onabotulinumtoxinA, both 900 kDa botulinum toxin type A complexes,
were studied in subjects with glabellar lines, also known as "frown
lines" between the eyebrows. "The EVB-003 data presentation marks a
milestone achievement for the prabotulinumtoxinA clinical program",
commented Rui Avelar, M.D., Chief
Medical Officer of Evolus.
About the Phase III EVB-003 Study
EVB-003 was a
150-day, multicenter, randomized, double-blind, active- and
placebo-controlled, single-dose Phase III non-inferiority study.
Adults aged 18 or older with moderate to severe glabellar lines at
maximum frown, as assessed by the investigator on the 4-point
Glabellar Line Scale (GLS, 0=no lines, 1=mild, 2=moderate,
3=severe), were enrolled provided that they also felt their
glabellar lines had an important psychological impact.
Randomization was 5:5:1 to receive a single treatment of 20 U
prabotulinumtoxinA, 20 U onabotulinumtoxinA or placebo (0.9%
saline). The primary efficacy endpoint was measured on Day 30 and a
responder was defined as a GLS score of 0 or 1 at maximum frown as
assessed by the investigator. A total of 540 were enrolled: 245
received prabotulinumtoxinA; 246 received onabotulinumtoxinA; and
49 received placebo. The study met the primary endpoint of
non-inferiority at Day 30 with responder rates of 87.2% in the
prabotulinumtoxinA group, 82.8% in the onabotulinumtoxinA group,
and 4.2% in the placebo group. The adverse event assessed as
study-drug related was 15.5%, 14.6% and 4.1% in the
prabotulinumtoxinA, onabotulinumtoxinA and placebo groups,
respectively. There were no serious adverse events that were
assessed as study-drug related.
About PrabotulinumtoxinA
PrabotulinumtoxinA is a 900
kDa purified botulinum toxin type A complex. The product
candidate's Biologics License Application (BLA) is currently under
review by the U.S. Food and Drug Administration (FDA). The
product candidate's Marketing Authorization Application (MAA) is
currently also under review by the European Medicines Agency (EMA).
The FDA application is for the temporary improvement in the
appearance of moderate to severe glabellar lines associated with
corrugator and/or procerus muscle activity in adults. The EMA
application is for temporary improvement in the appearance of
moderate to severe vertical lines between the eyebrows seen at
maximum frown (glabellar lines), when the severity has an important
psychological impact in adult patients.
About Evolus, Inc.
Evolus, Inc. is a medical
aesthetics company focused on providing physicians and their
patients with expanded choices in aesthetic procedures and
treatments. Evolus, Inc. focuses on the self-pay aesthetic market
and our lead product candidate is an injectable 900 kDa purified
botulinum toxin type A complex.
Evolus Press Contacts:
September Riharb, Vice President,
Marketing
Tel: +1-805-764-6300
Email: September.Riharb@Evolus.com
Jeff Plumer, Vice President, Legal
Tel: +1-949-284-4555
Email: Jeff.Plumer@Evolus.com
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SOURCE Evolus, Inc.