Attached files
| file | filename |
|---|---|
| EX-99.1 - EX-99.1 - AERIE PHARMACEUTICALS INC | d747861dex991.htm |
| 8-K - FORM 8-K - AERIE PHARMACEUTICALS INC | d747861d8k.htm |
 Primary efficacy endpoint: Mean diurnal
IOP on Day 29
Two concentrations of Roclatan™
vs.
Rhopressa™
0.02% and latanoprost
Trial design similar to registration trial
for another fixed-dose combination
-
Statistically significant difference
at measured time
points -
higher combo efficacy vs. components
of at least 1-3 mmHg, as previously
accepted by FDA for product approval
Roclatan™
Phase
2b
Clinical
Trial
Design
Phase
2b
Protocol
Roclatan™
0.01%
vs.
Roclatan™
0.02%
vs.
Rhopressa™
0.02%
vs.
Latanoprost
All dosed QD PM
~300 Patients
28 days
1
Exhibit 99.2 |
 Roclatan™
Phase 2b
Summary
Roclatan
TM
met primary efficacy measure of superiority over each of
the components on day 29
Roclatan
TM
mean diurnal IOP reduction on day 29 was approximately 2
mmHg superior to latanoprost
Roclatan
TM
met statistical superiority over the individual components
at all time points
The
efficacy
difference
between
Roclatan
TM
and
latanoprost
across
all
time points was 1.6 –
3.2 mmHg
The
efficacy
difference
between
Roclatan
TM
and
Rhopressa
TM
across
all
time points was 1.7 –
3.4 mmHg
The main adverse event was hyperemia, or eye redness, which was
reported in 40 percent of patients and was scored as mild for the large
majority of the patients. No systemic drug-related adverse events.
2 |
 Roclatan™
Phase 2b
Table of Efficacy at All Time Points ITT*
3
Mean IOP (mmHg) by Treatment Group and Treatment Difference in
Mean IOP
0.02%
Roclatan™
0.005% Latanoprost
0.02% Rhopressa™
(n = 72)
(n = 73)
(n = 78)
Mean
Mean
Difference
Mean
Difference
Day 8
8:00 AM
17.0
19.6
-2.6
20.0
-3.1
10:00 AM
15.6
18.3
-2.7
18.0
-2.4
4:00 PM
15.6
18.6
-3.1
17.9
-2.3
Day 15
8:00 AM
16.5
19.6
-3.2
19.6
-3.1
10:00 AM
15.8
18.3
-2.4
18.7
-2.8
4:00 PM
15.7
18.3
-2.6
18.4
-2.7
Day 29
8:00 AM
16.9
19.2
-2.4
20.3
-3.4
10:00 AM
15.9
17.7
-1.8
18.6
-2.7
4:00 PM
16.8
18.4
-1.6
18.5
-1.7
Roclatan™
vs
Latanoprost
Roclatan™
vs
Rhopressa™
1.6 to 3.2
1.7 to 3.4
* Intent to Treat |
 4
AR-13324 = Rhopressa™
PG324 = Roclatan™
Roclatan™
Phase 2b, ITT*
* Intent to Treat |
 AR-13324 =
Rhopressa™ PG324 = Roclatan™
5
Roclatan™ Phase 2b % of patients
with IOP drops of > 20% |
 Roclatan™
Phase 2b
% of Patients with IOP Drops of <
18 mmHg
AR-13324 = Rhopressa™
PG324 = Roclatan™
6 |