26.06.2007 13:00:00
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Allergan Announces FDA Approval of Label Extensions for JUVEDERM(TM) Ultra and JUVEDERM(TM) Ultra Plus
Allergan, Inc. (NYSE:AGN), the maker of BOTOX®
Cosmetic (Botulinum Toxin Type A), today announced approval by the U.S.
Food and Drug Administration (FDA) of label extensions for JUVÉDERM™
Ultra and JUVÉDERM™
Ultra Plus based on new clinical data demonstrating that the effects of
both products may last for up to one year, which is longer than reported
in clinical studies that supported FDA approval of other hyaluronic acid
(HA) dermal fillers.
"Patients are looking for longer-lasting,
science-based products that fill in lines, such as the parentheses
around the mouth, as part of their overall anti-aging skin care regimen,”
said Robert Grant, President of Allergan Medical, a division of
Allergan. "We are pleased to provide
physicians with the only HA dermal filler products currently approved in
the United States to provide smooth, natural looking results lasting up
to one year with a single treatment.”
Mark Pinsky, M.D., a West Palm Beach, Fla.-based plastic surgeon and a
clinical investigator in the study that supported the label extensions,
said, "The results of this study are exciting
because they establish JUVÉDERM™ Ultra and JUVÉDERM™
Ultra Plus as the only HA dermal fillers approved on the market today to
have proven persistence up to one year, which is an important attribute
to patients. Most patients and physicians want fillers that are
long-lasting and reversible – unlike
semi-permanent or permanent products –
because they provide a natural look that can be adjusted over time as
the face changes.”
JUVÉDERM™ Ultra and JUVÉDERM™
Ultra Plus are the only HA dermal fillers developed using the
proprietary HYLACROSS™
technology, a technologically advanced manufacturing process that
results in a malleable, smooth gel that flows easily into the skin and
creates a smooth, natural look and feel. All other HA dermal fillers
currently on the market have a granular consistency gel. These granules
can be seen under 2.4X magnification as opposed to the smooth
consistency gel of the JUVÉDERM™
family of products.
About the Study
The JUVÉDERM™
Ultra and JUVÉDERM™
Ultra Plus label extensions are based on long-term, follow-up data
evaluating the longevity of clinical improvement for up to 1.5 years
after treatment in 225 patients that originally participated in a
six-month, multi-center, double blind, randomized pivotal study
evaluating the safety and effectiveness of JUVÉDERM™
Ultra and JUVÉDERM™
Ultra Plus.
The original, pivotal study included 292 subjects who were randomly
assigned treatment with JUVÉDERM™
Ultra or JUVÉDERM™
Ultra Plus in one nasolabial fold (NLF) and ZYPLAST®
bovine collagen in the other NLF. NLFs were graded on a 5-point Wrinkle
Assessment Scale (from 0 = no wrinkle to 5 = extreme, deep wrinkle with
overlapping skin) together with a validated photographic guide. At the
six month end of the pivotal trial, the mean improvement was clinically
significant (=1-point improvement from
baseline) with JUVÉDERM™
Ultra or JUVÉDERM™
Ultra Plus treatment – but not with ZYPLAST®.
After completion of the pivotal trial, subjects could return for a
complimentary follow-up treatment, at which time their NLF scores were
again evaluated. More than three-quarters of JUVÉDERM™
Ultra and JUVÉDERM™
Ultra Plus pivotal study participants (79% and 76%, respectively)
returned for repeat treatment. The mean level of improvement remained
clinically significant for a large majority of the subjects who returned
at 6-9 months as well as for those who returned beyond 9 months (84% and
92% at 6-9 months, and 75% and 81% beyond 9 months with JUVÉDERM™
Ultra and JUVÉDERM™
Ultra Plus, respectively). Additionally, 23 JUVÉDERM™
Ultra Plus subjects returned more than 48 weeks (1 year) after their
last injection and of these, 78% had maintained improvement.
A subset of 48 subjects were then enrolled in a second study that
followed subjects for 6-12 months after repeat treatment. Throughout the
year-long follow-up period, JUVÉDERM™
Ultra and JUVÉDERM™
Ultra Plus provided clinically significant improvement in NLF severity,
with a large majority of subjects demonstrating improvement at 6 months
and beyond. At 6 months after repeat treatment, 87% of subjects treated
with JUVÉDERM™
Ultra and 91% of subjects treated with JUVÉDERM™
Ultra Plus had maintained improvement. At 1 year after repeat treatment,
78% of JUVÉDERM™
Ultra subjects and 90% of JUVÉDERM™
Ultra Plus subjects had maintained improvement.
During the studies, no subjects discontinued treatment due to lack of
effectiveness or adverse events and no serious treatment-related adverse
events were reported with any of the fillers. The frequency and severity
of treatment site reactions was similar for all the fillers, with the
majority of treatment site reactions lasting seven days or less. There
were no treatment-related adverse events other than those localized to
the area of injection and in general site reactions were mild or
moderate in severity and did not require intervention.
This study was sponsored by Allergan.
Important JUVÉDERM™
Dermal Filler Safety Information
JUVÉDERM™
is indicated for injection into the mid to deep dermis for correction of
moderate to severe facial wrinkles and folds (such as nasolabial folds),
and is generally well tolerated. In clinical studies, adverse events
were usually mild to moderate in nature, did not require intervention
and lasted seven days or less. The most common side effects included
temporary injection site reactions including redness, pain/tenderness,
firmness, swelling, lumps and bumps and bruising. For complete patient
safety and prescribing information, please visit www.Juvederm.com.
About Allergan, Inc.
With more than 55 years of experience providing high-quality,
science-based products, Allergan, Inc., with headquarters in Irvine,
California, discovers, develops and commercializes products in the
ophthalmology, neurosciences, medical dermatology, medical aesthetics,
obesity intervention and other specialty markets that deliver value to
its customers, satisfy unmet medical needs, and improve patients' lives.
About Allergan Medical
Allergan Medical, a division of Allergan, Inc., offers the most
comprehensive, science-based, aesthetic product offerings under its
Total Facial Rejuvenation portfolio, including BOTOX®
Cosmetic; hyaluronic acid and collagen-based dermal fillers; and
physician-dispensed skin care products. Allergan Medical also offers the
industry's widest range of breast implant options for reconstructive and
aesthetic breast surgery, and leading minimally invasive devices for
obesity intervention treatment.
Forward-Looking Statements
This press release contains "forward-looking statements", including the
statements by Dr. Pinsky and Mr. Grant, statements regarding research
and development outcomes, efficacy, market and product potential and
other statements regarding JUVEDERM™
dermal fillers. These statements are based on current expectations of
future events. If underlying assumptions prove inaccurate or unknown
risks or uncertainties materialize, actual results could vary materially
from Allergan's expectations and projections. Risks and uncertainties
include, among other things, general industry and market conditions;
technological advances and patents attained by competitors; challenges
inherent in the research and development and regulatory processes;
challenges related to product marketing, such as the unpredictability of
market acceptance for new products and/or the acceptance of new
indications for such products; inconsistency of treatment results among
patients and the potential for product failures; unknown risks
associated with the investigational devices that are the subject of
Allergan's clinical trials; potential difficulties in manufacturing new
products; and governmental laws and regulations affecting domestic and
foreign operations. Allergan expressly disclaims any intent or
obligation to update these forward-looking statements except as required
to do so by law.
Additional information concerning these and other risk factors can be
found in press releases issued by Allergan, as well as Allergan's public
periodic filings with the Securities and Exchange Commission, including
the discussion under the heading "Risk Factors”
in Allergan’s 2006 Form 10-K and Allergan’s
Form 10-Q for the quarter ended March 30, 2007. Copies of Allergan's
press releases and additional information about Allergan is available on
the World Wide Web at www.allergan.com
or you can contact the Allergan Investor Relations Department by calling
1-714-246-4636.
© 2007 Allergan,
Inc. Irvine, CA 92612. ®
and ™ marks
owned by Allergan, Inc.
JUVÉDERM™
is a mark owned by Corneal Industries SAS
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