Shire Reports Top-Line Results on OPUS-2, a Phase 3 Study Investigating the
Use of Lifitegrast (5.0% Ophthalmic Solution) in Adults With Dry Eye Disease
LEXINGTON, Massachusetts, December 5, 2013
LEXINGTON, Massachusetts, December 5, 2013 /PRNewswire/ --
Shire plc (LSE: SHP, NASDAQ: SHPG), the global specialty biopharmaceutical
company, today announced top-line results from OPUS-2, a Phase 3 efficacy and
safety study of 5.0% lifitegrast ophthalmic solution. OPUS-2 compared
lifitegrast to placebo administered twice daily for 84 days (12 weeks) in dry
eye patients with history of active artificial tear use within 30 days prior
to screening. Lifitegrast met the prespecified co-primary endpoint for the
patient-reported symptom of eye dryness (change in Eye Dryness Score from
baseline to week 12) (p-value<0.0001). Lifitegrast did not meet the
prespecified co-primary endpoint for the sign of inferior corneal staining
score (change from baseline to Week 12) using fluorescein staining compared
with placebo (p-value=0.6186).
"In this clinical trial, we note that lifitegrast showed a statistically
significant improvement in the prespecified symptoms of dry eye disease and is
the first drug to do so in a phase 3 clinical trial," said Flemming Ornskov,
M.D., Chief Executive Officer, Shire. "We will be examining the totality of
the data for lifitegrast in OPUS-2, as well as OPUS-1 and across the entire
clinical trial program. We look forward to discussing the lifitegrast program
with regulatory authorities."
The study also evaluated the safety and tolerability of lifitegrast based on
occurrence of treatment-emergent adverse events (TEAEs). The most commonly
reported TEAEs associated with lifitegrast were dysgeusia (altered sense of
taste) (16.2% vs 0.3% for placebo), instillation site irritation (7.8% vs 1.4%
for placebo), instillation site reaction (7.0% vs 1.1% for placebo) and visual
acuity reduced (5.0% vs 6.4% for placebo). There were no ocular serious TEAEs
or drug-related serious TEAEs. 93.2% of patients enrolled in the study
remained for the entire duration of the 12-week clinical trial.
ABOUT THE LIFITEGRAST PHASE 3 CLINICAL DEVELOPMENT PROGRAM
OPUS-1, OPUS-2 and SONATA currently make up the phase 3 clinical development
program for lifitegrast.
OPUS-1 was a multicenter, placebo-controlled trial conducted in a controlled
adverse environment with 588 dry eye subjects to investigate the efficacy and
safety of lifitegrast (5.0% solution) versus placebo twice daily for 84 days.
*In OPUS-1, the pre-specified co-primary endpoints were: 1) mean change
from baseline to Day 84 in the inferior corneal fluorescein staining score
(i.e., "sign"); and 2) the mean change from baseline to Day 84 in the
Visual Related (VR) function subscale of the Ocular Surface Disease Index
(OSDI) (i.e., "symptom"). In this study, lifitegrast demonstrated
superiority over placebo on the sign endpoint of improvement of the
inferior corneal fluorescein staining score (P=0.0007). Ocular surface
damage, which is a hallmark of chronic inflammation from dry eye disease,
is often detected using this staining parameter. However, the co-primary
symptom endpoint, the VR function subscale of the OSDI, did not achieve
*There were no serious ocular adverse events. The most commonly reported
ocular adverse events were irritation and pain upon initial instillation,
and were generally mild in severity.
OPUS-2, initiated in December 2012, was conducted in the natural environment
and compared lifitegrast to placebo administered twice daily for 84 days (12
weeks) in dry eye patients with history of active artificial tear use within
30 days prior to screening.
OPUS-2 was a multicenter, randomized, double-masked, placebo-controlled,
parallel-arm study with a 14-day open-label placebo screening run-in period.
Patients randomized into the study were not allowed to use artificial tears
during the study. Overall, 718 patients were randomized at 31 US sites. The
study consisted of 5 visits over 98 days: screening visits Day -14 (Visit 1)
to Day 0 (Visit 2), and treatment visits at Day 0 (Visit 2), Day 14 (Visit 3),
Day 42 (Visit 4), and Day 84 (Visit 5).
SONATA, which was initiated in December 2012, is a prospective, randomized,
double-masked, placebo-controlled trial in 300 dry eye subjects to evaluate
the safety of lifitegrast for 1 year. This trial is scheduled for completion
in mid 2014.
Lifitegrast, a small-molecule integrin antagonist, was designed in order to
treat dry eye disease, and is a preservative-free topical eye solution.
Lifitegrast is believed to work by reducing inflammation through inhibition of
lymphocyte function-associated antigen 1 (LFA-1) and preventing its binding to
intercellular adhesion molecule-1 (ICAM-1) that influences T-cell activation
and cytokine (protein) release. The interaction between these two proteins
plays a key role in the chronic inflammation associated with dry eye. T-cells
are important components of the immune system that help control the body's
response to a foreign or harmful substance or stimuli.
ABOUT DRY EYE DISEASE
As defined by the International Dry Eye Workshop in 2007, dry eye is a
multifactorial disease of the tears and ocular surface that results in
symptoms of discomfort, visual disturbance, and tear film instability with
potential damage to the ocular surface. It is accompanied by increased
osmolarity of the tear film and inflammation of the ocular surface.
NOTES TO EDITORS
Shire enables people with life-altering conditions to lead better lives.
Our strategy is to focus on developing and marketing innovative specialty
medicines to meet significant unmet patient needs.
We provide treatments in Neuroscience, Rare Diseases, Gastrointestinal,
Internal Medicine and Regenerative Medicine and we are developing treatments
for symptomatic conditions treated by specialist physicians in other targeted
FORWARD - LOOKING STATEMENTS - "SAFE HARBOR" STATEMENT UNDER THE PRIVATE
SECURITIES LITIGATION REFORM ACT OF 1995
Statements included in this announcement that are not historical facts are
forward-looking statements. Forward-looking statements involve a number of
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adversely affected. The risks and uncertainties include, but are not limited
*Shire's products may not be a commercial success;
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