EX-99.2 3 d942648dex992.htm EX-99.2 EX-99.2
Aerie Pharmaceuticals, Inc.
June 15, 2015
Clinical Trial
Update
Exhibit 99.2


2
Important Information
The information in this presentation is current only as of its date and may have changed or may change
in the future. We undertake no obligation to update this information in light of new information, future
events or otherwise. We are not making any representation or warranty that the information in this
presentation is accurate or complete.
Certain statements in this presentation are “forward-looking statements” within the meaning of the federal
securities laws. Words such as “may,” “will,” “should,” “would,” “could,” “believe,” “expects,” “anticipates,”
“plans,” “intends,” “estimates,” “targets,” “projects,” “potential” or similar expressions are intended to
identify these forward-looking statements. These statements are based on the Company’s current plans
and expectations. Known and unknown risks, uncertainties and other factors could cause actual results to
differ materially from those contemplated by the statements. In evaluating these statements, you should
specifically consider various factors that may cause our actual results to differ materially from any
forward-looking statements. These risks and uncertainties are described more fully in the quarterly and
annual reports that we file with the SEC, particularly in the sections titled “Risk Factors” and
“Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Such
forward-looking statements only speak as of the date they are made. We undertake no obligation to
publicly update or revise any forward-looking statements, whether because of new information, future
events or otherwise, except as otherwise required by law.
Any discussion of the potential use or expected success of our product candidates is subject to our
product candidates being approved by regulatory authorities. In addition, any discussion of clinical trial
results for Rhopressa
TM
relate to the results in its first Phase 3 registration trial, Rocket 1, and for
Roclatan
TM
relate to the results in its Phase 2b clinical trial.


3
Rhopressa
TM
Update: Rocket 2
Rocket 2 primary endpoint range being changed with FDA agreement
-
New primary endpoint range is above 20 mmHg to below 25 mmHg
below 25 mmHg
-
No additional patient enrollment necessary 
Rocket 2 data base not yet locked; patients still being treated
Efficacy read-out expected end of Q3 2015
If Rocket 2 is successful, NDA filing expected 2H 2016
-
Statistical change allowed; Rocket 2 adequately powered at 


4
Rocket 1: Baseline IOP < 25 mmHg At All
Time Points


5
Rocket 1: Baseline IOP < 25 mmHg At All
Time Points
Mean IOP
Rhopressa
TM
Timolol
(95% CI)
Rhopressa
TM
Timolol
Mean Difference
95% CI
N=107
N=120
Baseline
8:00 AM
22.3
22.5
10:00 AM
21.2
21.0
4:00 PM
20.6
20.4
Mean Diurnal
21.4
21.3
Day 15
8:00 AM
17.2
17.8
-0.6
-1.3, 0.0)
10:00 AM
16.1
17.0
-0.9
-1.6, -0.2)
4:00 PM
16.2
17.2
-1.0
-1.7, -0.3)
Mean Diurnal
16.5
17.3
-0.8
-1.4, -0.3)
Day 43
8:00 AM
17.8
17.8
0.0
-0.7, 0.7)
10:00 AM
16.8
17.0
-0.2
-0.9, 0.5)
4:00 PM
16.5
17.3
-0.7
-1.4, 0.0)
Mean Diurnal
17.1
17.4
-0.3
-0.9, 0.3)
Day 90
8:00 AM
18.1
18.0
0.2
-0.5, 0.9)
10:00 AM
17.3
17.4
-0.1
-0.8, 0.7)
4:00 PM
17.0
17.4
-0.4
-1.1, 0.3)
Mean Diurnal
17.5
17.6
-0.1
-0.7, 0.5)


6
Rocket 1: Rhopressa
TM
Efficacy in Subjects On PGA  
Prior To Study
(Baseline IOP < 25 mmHg)
Prior PGA use produced enhanced IOP-lowering with Rhopressa
TM
at
weeks 2 and 6
IOP lowering at month 3 equivalent to IOP lowering in non-PGA subjects
Prior PGA use had no effect on Timolol
efficacy


7
Rocket 1: Rhopressa
TM
Efficacy In Subjects Not on PGA
Prior To Study (Baseline IOP < 25 mmHg)
No loss of efficacy seen from week 2 to month 3 for Rhopressa
TM
or Timolol


8
Rhopressa
TM
Next Steps: Rocket 4
Planning
to
commence
Rocket
4
in
Q3
2015,
an
additional
Rhopressa
TM
trial in the U.S.
Baseline IOPs:
-
Primary <25 mmHg to mirror revised Rocket 2
-
Pre-specified secondary <27 mmHg
-
Considering stratification
-
May enroll patients up to 30 mmHg
Efficacy evaluated at 3 months (primary) and 6 months (secondary)
Final design to be reviewed with FDA
Read-out expected in approximately one year
Adds
over
200
additional
Rhopressa
TM
patients
for
6
month
EU
safety


9
Roclatan
TM
Next Steps
Commencing “Mercury 1” in Q3 2015 in the U.S.
-
Designed for superiority to individual components, similar to P2b
-
Baseline IOP range tentatively > 20 mmHg to <36 mmHg, with    
stratified enrollment
-
Multiple secondary endpoints                   
-
Efficacy trial with one year safety
“Mercury 2” expected to commence in 2016 in the U.S.
-
Expect same comparators as Mercury 1
-
Three month efficacy study
“Mercury 3” expected to commence in 2016 in Europe
-
Comparing to a leading combo product marketed in EU
-
Efficacy study, duration TBD