LATISSE
news and safety
ALLERGAN
ANNOUNCES THE LATISSE WISHES CAMPAIGN, COMMITTING $1
MILLION TO THE MAKE-A-WISH FOUNDATION®
Register on LATISSE Web Site
to Help Reach Goal
(IRVINE,
Calif., March 27, 2009) /PRNewswire/ Allergan, Inc.
(NYSE: AGN) hosted a star-studded event last night in Hollywood
to launch LATISSE
Wishes, a charitable public awareness campaign designed to
help make wishes come true. Actress Brooke Shields and beauty
expert to the stars Anastasia Soare will lead the campaign
to generate $1 million to support the Make-A-Wish Foundation,
a non-profit organization dedicated to granting the wishes
of children with life-threatening medical conditions.
The LATISSE
Wishes campaign was borne out of the tradition of blowing
on an eyelash to make a wish come true and leverages the excitement
surrounding the availability of Allergan's LATISSE (bimatoprost
ophthalmic solution) 0.03%, the first and only science-based
prescription treatment approved by the U.S. Food and Drug
Administration for hypotrichosis of the eyelashes (inadequate
or not enough lashes) that is used to grow eyelashes, making
them longer, fuller and darker.
"In
the short time LATISSE has been available, the product
has already made many women's wish lists," said David
E. I. Pyott, Chairman of the Board and Chief Executive Officer
of Allergan. "While LATISSE may fulfill the wish
for more prominent eyelashes, we also wanted to shine the
spotlight on the Make-A-Wish Foundation and provide support
for the important work it does in granting children's wishes."
The LATISSE
Wishes campaign launched with an initial donation of $500,000
from Allergan to the Make-A-Wish Foundation. Consumers are
encouraged to help double this amount to $1 million by registering
their support at www.LATISSE.com to help grant the wishes
of children in their local communities. Between
now and December 31, 2009, Allergan will donate $5 for each
new visitor who registers online, up to an additional $500,000.
"Every
40 minutes the Make-A-Wish Foundation grants a wish to a child
with a life-threatening medical condition. Forty seconds is
all it takes to visit www.LATISSE.com to register your support
and help make wishes come true," said David Williams,
president and chief executive officer of the Make-A-Wish Foundation.
"We urge everyone to log on to the LATISSE Web
site and register their support to help grant the wishes of
children in their communities."
"I
am delighted to be a part of LATISSE Wishes, to not
only help educate women on an eyelash growth product that
is the first to be scientifically proven, but also to support
a worthy organization such as the Make-A-Wish Foundation,"
said Shields. "I remember being a child and blowing on
an eyelash hoping my wish would come true, and as a mother
I've passed this tradition onto my children. Through LATISSE
Wishes and in partnership with Make-A-Wish Foundation, we
can keep the tradition alive and fulfill the hopes of so many
more children around the country."
In addition
to Shields and Soare, other stars including Debra Messing,
Angie Harmon, Marisa Tomei, Mandy Moore, Debi Mazar, Jewel,
Jennifer Coolidge and Perrey Reeves attended last night's
red-carpet kick-off event for the LATISSE Wishes campaign.
Over the next several months, campaign ambassadors Shields
and Soare, who both use LATISSE solution, will travel
to cities across the country hosting informational events
aimed to further support the campaign and its goal of providing
$1 million to the Make-A-Wish Foundation. Local events will
be held in New York, Miami, Dallas, Minneapolis and San Francisco.
"In
my business I constantly work to help make women's beauty
wishes come true and now we can help children's wishes come
true through the LATISSE Wishes campaign," said
Soare. "I am excited to bring this worthy campaign to
cities across the country."
For more
information about the LATISSE Wishes charitable awareness
campaign, please visit www.LATISSE.com.
Allergan
Announces U.S Food and Drug Administration (FDA) Approval
of LATISSE First and Only Treatment Approved
by the FDA for Hypotrichosis of Eyelashes
New Prescription Product Increases Length, Thickness and Darkness
of Eyelashes
(IRVINE,
Calif., December 26, 2008) Allergan, Inc. (NYSE: AGN)
today announced the U.S. Food and Drug Administration (FDA)
has approved LATISSE (bimatoprost ophthalmic solution)
0.03% as a novel treatment for hypotrichosis of the eyelashes.
Eyelash hypotrichosis is another name for having inadequate
or not enough eyelashes. LATISSE is the first and only
science-based treatment approved by the FDA to enhance eyelash
prominence as measured by increases in length, thickness and
darkness of eyelashes.
LATISSE
fulfills a significant and previously unmet need in the medical
aesthetic marketplace with a product approved by the FDA that
increases the growth of eyelashes, making them longer, thicker
and darker, said Scott Whitcup, M.D., Allergans
Executive Vice President of Research and Development. As
the global leader in medical aesthetics, LATISSE exemplifies
our continuing commitment to developing innovative treatments
that are studied in well-controlled clinical trials, manufactured
to pharmaceutical standards, appropriately labeled for use,
and available to consumers as a prescription product.
Available
only through a doctor, LATISSE is a once-daily prescription
treatment applied to the base of the upper eyelashes with
a sterile, single-use-per-eye disposable applicator. LATISSE
users can expect to experience longer, fuller and darker eyelashes
in as little as eight weeks, with full results in 16 weeks.
To maintain effect, continued treatment with LATISSE
is required. If use of LATISSE is discontinued, eyelashes
will gradually return to where they were prior to treatment
over a period of weeks to months (average eyelash hair cycle).
Similar
to Allergans other medical aesthetic offerings, the
benefits of LATISSE are derived from scientific evidence,
its quality formulation, and medical origin. LATISSE
was clinically tested in a pivotal Phase III, multi-center,
double-masked, placebo-controlled study to assess its safety
and efficacy in which all endpoints (improved eyelash prominence,
length, thickness and darkness) were met. In addition, like
BOTOX® (botulinum toxin type A), which was first approved
by the FDA as a medical treatment for eye disorders and was
later found to have an aesthetic benefit, bimatoprost, the
active ingredient in LATISSE, was first approved in
2001 as a medical product to lower intraocular pressure in
people with open-angle glaucoma or ocular hypertension. Patients
treated with bimatoprost for this specific eye condition experienced
eyelash growth as a side effect. The long-term safety of bimatoprost
for therapeutic use has been recognized by the medical community
and well established based on use in 32 clinical trials involving
more than 5,700 glaucoma patients and more than 13 years of
clinical trial experience. Given the existing and substantial
clinical and post-marketing safety data with bimatoprost solution
0.03%, coupled with the positive results from the Phase III
LATISSE study, LATISSE provides patients a clinically
meaningful aesthetic benefit with a favorable safety profile.
Bimatoprost
is the active pharmaceutical ingredient in the formulation
of LATISSE and is a structural prostaglandin analog,
a lipid compound derived from fatty acids designed to bind
to prostaglandin (PG) receptors. PG receptors are present
in hair, particularly in the dermal papilla and outer root
sheath. Although the precise mechanism of action is unknown,
PG receptors are thought to be involved in the development
and regrowth of the hair follicle,i by increasing the percent
of hairs in, and the duration of, the anagen or growth phase.
Allergan
estimates global peak sales of LATISSE could exceed
$500 million per year. As the exclusive U.S. and foreign patent
owner, Allergan obtains the rights to the use of bimatoprost
and other prostaglandins and prostaglandin analogs as a treatment
to stimulate eyelash growth.
LATISSE
Clinical Development Program
In the pivotal Phase III study, 278 healthy adult patients
with no active ocular disease and with baseline minimal or
moderate eyelash prominence were randomized to apply either
LATISSE or vehicle to both upper eyelid margins once
daily for 16 weeks. The primary efficacy endpoint was overall
eyelash prominence at the end of the 16-week treatment period
as measured by a =1-grade improvement on a 4-point Global
Eyelash Assessment Scale. Secondary efficacy endpoints were
eyelash length, thickness, and darkness as determined by Digital
Image Analysis of patient photographs taken in a standardized
manner.
All of
the endpoints in the LATISSE pivotal trial were met.
By the end of the 16-week treatment period, patients treated
with LATISSE experienced statistically significant greater
improvement (p < 0.0001 for each endpoint) than those in
the vehicle group in the measurements of eyelash prominence,
length, thickness and darkness. LATISSE was also well
tolerated with the most commonly reported adverse events being
non-serious and cosmetic in nature. Common adverse events
observed in the clinical trial included eye redness (3.6%),
itchy eyes (3.6%) and skin hyperpigmentation (2.9%).
Is
LATISSE safe?
LATISSE is an FDA-approved prescription treatment for
hypotrichosis used to grow eyelashes, making them longer,
thicker and darker. Hypotrichosis is another name for having
inadequate or not enough eyelashes. The FDA reviewed clinical
study results to verify the identity, potency, purity, and
stability of the ingredients, and demonstrated that the product
is safe and effective for its intended use if used as prescribed.
LATISSE
solution is intended for use on the skin of the upper eyelid
margins at the base of the eyelashes. DO NOT APPLY to the
lower eyelid. If you are using LUMIGAN® or other products
in the same class for elevated intraocular pressure (IOP),
or if you have a history of abnormal IOP, you should only
use LATISSE under the close supervision of your doctor.
LATISSE
use may cause darkening of the eyelid skin which may be reversible.
Although not reported in clinical studies, LATISSE use
may also cause increased brown pigmentation of the colored
part of the eye which is likely to be permanent.
It is
possible for hair growth to occur in other areas of your skin
that LATISSE frequently touches. Any excess solution
outside the upper eyelid margin should be blotted with a tissue
or other absorbent material to reduce the chance of this from
happening. It is also possible for a difference in eyelash
length, thickness, fullness, pigmentation, number of eyelash
hairs, and/or direction of eyelash growth to occur between
eyes. These differences, should they occur, will usually go
away if you stop using LATISSE.
The most
common side effects after using LATISSE solution are
an itching sensation in the eyes and/or eye redness. This
was reported in approximately 4% of patients. LATISSE
solution may cause other less common side effects which typically
occur on the skin close to where LATISSE is applied,
or in the eyes. These include skin darkening, eye irritation,
dryness of the eyes, and redness of the eyelids.
If you
develop a new ocular condition (e.g., trauma or infection),
experience a sudden decrease in visual acuity, have ocular
surgery, or develop any ocular reactions, particularly conjunctivitis
and eyelid reactions, you should immediately seek your doctors
advice concerning the continued use of LATISSE solution.
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