FDA Approves Shire's Xiidra™ (lifitegrast ophthalmic solution) 5% - The Only
Treatment Indicated for the Signs and Symptoms of Dry Eye Disease
* An estimated 16 million people in the U.S. are diagnosed with dry eye
disease
* Xiidra is the first prescription eye drop FDA-approved to treat both the
signs and symptoms of dry eye disease
* U.S. launch of Xiidra planned for third quarter 2016
Lexington, Mass. - July 12, 2016 - Shire plc (LSE: SHP, NASDAQ: SHPG) announces
that the U.S. Food and Drug Administration (FDA) has approved Xiidra
(lifitegrast ophthalmic solution) 5%, a twice-daily eye drop solution indicated
for the treatment of the signs and symptoms of dry eye disease in adult
patients. Xiidra is the only prescription eye drop indicated for the treatment
of both signs and symptoms of this condition. Shire expects to launch Xiidra in
the United States in the third quarter of 2016.
"The approval of Xiidra marks a new day in treatment options for patients with
dry eye disease, with the only prescription eye drop approved in the U.S.
specifically to treat both the signs and symptoms of the condition," said
Flemming Ornskov, M.D., MPH, CEO, Shire. "As Shire's first FDA-approved
medicine in ophthalmics, this significant milestone advances our goal of
becoming the global leader in this category, where there are unmet patient
needs. We have a robust ophthalmics pipeline, and we look forward to leveraging
Xiidra as our entrée into the space as we continue to develop additional
innovative eye care treatment options."
An estimated 16 million adults in the U.S. are diagnosed with dry eye disease.
An often chronic ocular disease, dry eye is associated with inflammation that
may eventually lead to damage to the surface of the eye. An eye care
professional can diagnose dry eye disease based on signs and symptoms and
determine management options, which could include the use of a prescription
treatment.
"The clinical program supporting the approval of Xiidra is the largest for an
investigational-stage dry eye disease candidate to date, including more than
2,500 patients," said Edward Holland, M.D., Professor of Clinical
Ophthalmology, University of Cincinnati and a clinical trial investigator for
Xiidra. "The clinical trial program design took into consideration many of the
challenges of past dry eye research. It's exciting to see Xiidra as the first
prescription eye drop FDA-approved for both the signs and symptoms of the
condition."
Xiidra is a prescription eye drop solution used to treat the signs and symptoms
of dry eye disease. It is dosed twice per day, approximately 12 hours apart, in
each eye. The safety and efficacy of Xiidra was studied in 1,181 patients (of
which 1,067 patients received lifitegrast 5%) in four placebo-controlled
12-week trials. Each of the four studies assessed the effect of Xiidra on both
the signs and symptoms of dry eye disease at baseline, week two, six and 12.
Assessment of symptoms was based on change from baseline in patient reported
eye dryness score (EDS; 0-100 visual analogue scale). Assessment of signs was
based on inferior corneal staining score (ICSS; 0-4 scale). In all four
studies, a larger reduction in EDS was observed with Xiidra at six and 12
weeks. In two of the four studies, an improvement in EDS was seen with Xiidra
at two weeks. At week 12, a larger reduction in ICSS favoring Xiidra was
observed in three of the four studies. The most common adverse reactions
reported in 5 to 25 percent of patients were instillation site irritation,
altered taste sensation (dysgeusia) and reduced visual acuity.
"Dry eye is a common complaint to eye care professionals, with millions of U.S.
adults experiencing the symptoms of this often chronic disease," said Kelly K.
Nichols, O.D., MPH, Ph.D., FAAO, Dean of the University of Alabama at
Birmingham School of Optometry. "It is critical for eye care professionals to
have a dialogue with patients who report symptoms because dry eye can be a
progressive ocular surface disease."
The inflammation associated with dry eye is thought to be primarily mediated by
T-cells and associated cytokines. One effect of this process may be increased
expression of intracellular adhesion molecule-1 (ICAM-1); ICAM 1 may be
overexpressed in corneal and conjunctival tissues in dry eye disease.
Lifitegrast is a small-molecule integrin antagonist that binds to the integrin
lymphocyte function-associated antigen-1 (LFA-1), a cell surface protein found
on leukocytes, and blocks the interaction of LFA-1 with its cognate ligand
intercellular adhesion molecule?1 (ICAM?1). LFA?1/ICAM?1 interaction can
contribute to the formation of an immunological synapse resulting in T?cell
activation and migration to target tissues. In vitro studies demonstrated that
lifitegrast may inhibit T?cell adhesion to ICAM?1 in a human T-cell line and
may inhibit secretion of inflammatory mediators (cytokines) in human peripheral
blood mononuclear cells. The exact mechanism of action of lifitegrast in dry
eye disease is not known.
What is Xiidra?
Xiidra is a prescription eye drop used to treat the signs and symptoms of dry
eye disease.
Important Safety Information
The most common side effects of Xiidra include eye irritation, discomfort or
blurred vision when the drops are applied to the eyes, and an unusual taste
sensation (dysgeusia). To help avoid eye injury or contamination of the
solution, do not touch the container tip to your eye or any surface. If you
wear contact lenses, remove them before using Xiidra and wait for at least 15
minutes before placing them back in your eyes.
It is not known if Xiidra is safe and effective in children under 17 years of
age.
For additional information, click here for full Prescribing Information
including Patient Information and discuss with your doctor.
You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.
About Dry Eye Disease
Dry eye is a multifactorial disease of the tears and ocular surface. It is
diagnosed by an eye care professional based on patient reported symptoms, such
as eye dryness, overall eye discomfort, stinging, burning, a gritty feeling or
fluctuating blurry vision, as well as signs, which can be objectively evaluated
by an eye care professional through various tests to determine the presence of
dry eye disease. The symptoms of dry eye can interrupt daily activities such as
reading, driving, working, using technology, watching TV, and spending time
outside in bright light and cold or windy conditions. Aging and gender (female)
are recognized as traditional risk factors of dry eye disease while modern risk
factors include prolonged digital/computer screen time, contact lens wear and
cataract or refractive surgery. Dry eye is an often chronic ocular disease
associated with inflammation that may eventually lead to damage to the surface
of the eye. Dry eye may be progressive and is a common patient complaint to eye
care professionals.
Shire's Commitment to Ophthalmics
In May 2014, Shire entered into ophthalmics, solidifying its commitment to
growing in this emerging therapeutic area. Shire's multi-faceted approach to
discovery, development, and delivery in both rare diseases and specialty
conditions includes our efforts to address unmet needs in eye care.
Shire's ophthalmics business has been driven by a combination of strategic
acquisitions and organic growth. Committed to growing its reputation as a
leading biotech company, Shire is focused on continuing to expand its
ophthalmics portfolio to include treatment options for rare diseases and those
for anterior and posterior segment eye conditions. In just three years,
acquisitions include Foresight Biotherapeutics, SARcode Bioscience, Premacure
AB, and BIKAM Pharmaceuticals, which have helped bolster Shire's early-, mid-
and late-stage ophthalmics pipeline. The Company currently has an ophthalmics
pipeline of investigational candidates in infectious conjunctivitis,
retinopathy of prematurity, autosomal dominant retinitis pigmentosa, and
glaucoma.
Stephen Williams, Deputy Company Secretary (responsible for arranging the
release of this announcement).
For further information please contact:
Investor Relations
Sarah Elton-Farr seltonfarr@shire.com +44 1256 894157
Ian Karp ikarp@shire.com +1 781 482 9018
Robert Coates rcoates@shire.com +44 1256 894874
Media
Gwen Fisher gfisher@shire.com +1 484 595 9836
Clotilde Houze chouze0@shire.com +1 781 266 3567
NOTES TO EDITORS
Inside Information
This announcement contains inside information.
About Shire
Shire is the leading global biotechnology company focused on serving people
with rare diseases and other highly specialized conditions. We strive to
develop best-in-class products, many of which are available in more than 100
countries, across core therapeutic areas including Hematology, Immunology,
Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal /
Internal Medicine / Endocrine and Hereditary Angioedema; and a growing
franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and
deliver breakthrough therapies for the hundreds of millions of people in the
world affected by rare diseases and other high-need conditions, and who lack
effective therapies to live their lives to the fullest.
www.shire.com
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Annual Reports on Form 10-K for the year ended December 31, 2015.
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