EX-99.2 3 d927999dex992.htm EX-99.2 EX-99.2
EBI-005 Phase 3 Dry Eye
Disease Trial
May 18, 2015
Exhibit 99.2

•
Natural environmental study
•
Double masked, vehicle controlled
•
U.S. study, 669 subjects enrolled
•
Inclusion criteria
•
CFS: Screen moderate-to-severe
•
OSDI: Screen moderate-to-severe
•
<50 at randomization
•
Rescue tear use restricted
Objectives
•
•
•
5 to 7 Days
Prior to Day 1
Day 1
Week 3
Week 6
Week 9
Week 12
RUN IN
EVALUATION VISITS
FOLLOW UP
21 Days
Follow Up
Post Week 12
1
Week
Run In
3
Week
Follow
Up
Vehicle
Control
—
3
times
daily
(~325 Subjects)
EBI-005
5
mg/ml
—
3
times
daily
(~325 Subjects)
Screening
Randomization
Off Treatment
Week 1
CFS= Corneal Fluorescein Staining
OSDI= Ocular Surface Disease Index
2
Co-Primary: CFS; pain or soreness by OSDI
Secondary: e.g. Total OSDI; CFS regions
Safety, tolerability, and immunogenicity
EBI-005 Phase 3 Study in Dry Eye Disease

3
Vehicle
EBI-005
N
334
335
Age
59.75 (20-87)
59.65 (23-92)
Gender
82% F
83%F
Race
81% (White)
83% (White)
Drop Outs
20 (6%)
33 (10%)
AT use during study
43 (13%)
43 (13%)
Baseline Demographics

Differences between EBI-005 and vehicle were not statistically significant
-6
-5
-4
-3
-2
-1
0
0
1
3
6
9
12
15
Vehicle
EBI-005
Time (Weeks)
Change from Baseline for Total CFS at each Visit
(Standard Deviation)

Change from Baseline for OSDI Pain/Sore Eye at
each Visit (Standard Deviation)
Differences between EBI-005 and vehicle were not statistically significant
-1.6
-1.4
-1.2
-1
-0.8
-0.6
-0.4
-0.2
0
0
1
3
6
9
12
15
Vehicle
EBI-005
Time (Weeks)

Vehicle
(N=334)
EBI-005
(N=335)
Subjects with at least one TEAE
58 (17.4%)
68 (20.3%)
Eye Irritation
15 (4.5%)
15 (4.5%)
Eye Pain
8 (2.4%)
9 (2.7%)
Conjunctival Hyperemia
5 (1.5%)
9 (2.7%)
Eyelid Itching
5 (1.5%)
9 (2.7%)
All other ocular AE’s below 2%
Ocular Treatment Emergent Adverse Events

EBI-005-3
Baseline
Week 12
Total CFS
EBI-005
8.5
-2.4
Vehicle
8.6
-2.7
OSDI Pain
EBI-005
1.2
-.3
Vehicle
1.3
-.5
Phase 3 Study Baseline Values with Change
From Baseline (Week 12)