Aerie Pharmaceuticals 8K Reports Positive RoclatanTM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% Phase 312-month Topline Safety Results | AERI 19 Jul 17

Roclatan

Mercury 1 Phase 3 12-month

Topline Results

For Investor Use

Exhibit 99.2

Important Information

Any discussion of the potential use or expected success of our product candidates is subject to our

product candidates being approved by regulatory authorities.

The information in this presentation is current only as of its date and may have changed or may

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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.” In particular, the topline Mercury 1 data presented herein is preliminary and based solely

on information available to us as of the date of this press release and additional information about the

results may be disclosed at any time. 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.

For Investor Use

Roclatan

Achieves Positive 12-Month Safety

and Efficacy Results

•

Safety data over the 12 months were consistent with previous Roclatan™

3-month results

•

There were no drug-related serious or systemic adverse events

•

The main adverse event for Roclatan™ was conjunctival hyperemia, which

was reported in ~60% of patients, scored as mild for ~70% of these patients

and sporadic

•

IOP-lowering effect of Roclatan™ through Month 12 remained stable and

consistent with the primary efficacy analysis at Month 3, maintaining

superiority over both latanoprost and Rhopressa™

–

1-3 mmHg greater than monotherapy with either latanoprost or Rhopressa™

throughout the duration of the study (i.e., Week 2, Week 6, Month 3, Month 6,

Month 9 and Month 12)

–

At Month 12, Roclatan

reduced mean diurnal IOPs to 16 mmHg or lower in 60%

of patients, a significantly higher percentage than observed in the comparator arms

Data on File

Based on Mercury 1 Topline 12-month

Product candidates have not approved by the FDA

For Investor Use

Mercury 1 Trial Design

Patients randomized

1:1:1

Primary endpoints:

•

Efficacy: Mean IOP at nine time points (08:00, 10:00, and 16:00 at

Week 2, Week 6, and Month 3)

•

Safety: Ocular and systemic safety during a 12-month treatment period

Patients with open angle glaucoma (OAG) or ocular hypertension (OHT)

with IOP >20 mmHg and < 36 mmHg

N=718 subjects randomized at 58 US sites

Rhopressa

Netarsudil

(AR-13324) 0.02%

QD (PM)

Latanoprost

0.005%

QD (PM)

Product candidates have not approved by the FDA

For Investor Use

ClinicalTrials.gov Identifier: NCT02558400

Roclatan

PG324

(netarsudil/latanoprost)

QD (PM)

Disposition

Data on File

Based on Mercury 1 Topline 12-month

Product candidates have not approved by the FDA

For Investor Use

Roclatan

N = 238

Rhopressa

N = 244

Latanoprost

N = 236

Completed

Month

159 (66.8%)

148 (60.7%)

203 (86.0%)

Discontinued Prior to Month 12

79 (33.2%)

96 (39.3%)

33 (14.0%)

Reasons

for

Discontinuation

Adverse

Event

Withdrawal

Consent

Non-Compliant

Lost

Follow-up

Lack

Efficacy

Disallowed

Concurrent

Medication

Investigator Decision

Protocol Violation

Other

47 (19.7%)

13 (5.5%)

5 (2.1%)

6 (2.5%)

2 (0.8%)

6 (2.5%)

53 (21.7%)

9 (3.7%)

1 (0.4%)

5 (2.0%)

13 (5.3%)

7 (2.9%)

2 (0.8%)

3 (1.2%)

4 (1.7%)

8 (3.4%)

(1.3%)

4 (1.7%)

1 (0.4%)

5 (2.1%)

(3.4%)

Roclatan

Maintained Superior Efficacy Over

Individual Components for 12 Months

Mean IOP at Each Time Point (ITT)

•

Roclatan™ statistically superior to latanoprost and Rhopressa™ at all

time points

•

Roclatan™ IOP-lowering 1-3 mmHg greater than monotherapy through

Month 12

Data on File

Based on Mercury 1 Topline 12-month

Product candidates have not approved by the FDA

For Investor Use

Roclatan

Maintained Superior Efficacy Over

Individual Components for 12 Months

Mean Diurnal IOP at Each Visit (ITT)

p<0.0001 at All Visits vs. Latanoprost and Rhopressa

Data on File

Based on Mercury 1 Topline 12-month

Product candidates have not approved by the FDA

For Investor Use

Roclatan

Phase 3 Month 12 Responder Analysis:

Goal is to Achieve Lowest IOP Possible

At Month 12: % of Patients

with IOP Reduced to 18 mmHg or Lower

*p<0.05, **p<0.01, ***p<0.0001

Data on File

Based on Mercury 1 Topline 12-month

Product candidates have not approved by the FDA

For Investor Use

Efficacy in Subjects with Baseline IOP <25 mmHg

Mean IOP at Each Time Point (ITT)

•

Rhopressa

efficacy similar to latanoprost and stable for 12 months

Data on File

Based on Mercury 1 Topline 12-month

Product candidates have not approved by the FDA

For Investor Use

At Month 12: % of Patients

with IOP Reduced to 18 mmHg or Lower

Roclatan

Responder Analysis

Baseline IOP 25 mmHg

*p<0.05, **p<0.01

Data on File

Based on Mercury 1 Topline 12-month

Product candidates have not approved by the FDA

For Investor Use

At Month 12: % of Patients

with IOP Reduced to 18 mmHg or Lower

Roclatan

Responder Analysis

Baseline IOP

25 mmHg

*p<0.05 vs Latanoprost

**p<0.05 vs

Rhopressa

, p<0.0001 Latanoprost

***p<0.0001 vs

Rhopressa

, p<0.01 Latanoprost

Data on File

Based on Mercury 1 Topline 12-month

Product candidates have not approved by the FDA

For Investor Use

Safety/Tolerability Overview of Roclatan

•

There were no drug-related serious adverse events

(SAEs) and no evidence of treatment-related systemic

effects

•

The most common adverse event was conjunctival

hyperemia with ~60% incidence, scored as mild on

biomicroscopy for ~70% of these patients and sporadic

•

Other ocular AEs

–

AEs occurring in ~5-18% of subjects receiving Roclatan

included: cornea verticillata, conjunctival hemorrhage, eye

pruritus, lacrimation increased, visual acuity reduced, blepharitis

and punctate keratitis.

Data on File

Based on Mercury 1 Topline 12-month

Product candidates have not approved by the FDA

For Investor Use

Roclatan

Phase 3 Safety Profile

Adverse Events

( 5.0% in any group)

Roclatan

n=238

Rhopressa

n=243

Latanoprost

n=237

Eye Disorders

Conjunctival Hyperemia

150 (63.0%)

125 (51.4%)

52 (21.9%)

Conjunctival Hemorrhage

31 (13.0%)

44 (18.1%)

3 (1.3%)

Cornea Verticillata

42 (17.6%)

33 (13.6%)

Eye Pruritus

27 (11.3%)

22 (9.1%)

3 (1.3%)

Punctate Keratitis

12 (5.0%)

18 (7.4%)

10 (4.2%)

Lacrimation Increased

17 (7.1%)

20 (8.2%)

1 (0.4%)

Visual Acuity Reduced

13 (5.5%)

13 (5.3%)

6 (2.5%)

Vision Blurred

11 (4.6%)

15 (6.2%)

3 (1.3%)

Blepharitis

14 (5.9%)

8 (3.3%)

5 (2.1%)

Administration Site Conditions

Instillation site pain

55 (23.1%)

60 (24.7%)

18 (7.6%)

Patients with known contraindications or hypersensitivity to latanoprost

were

excluded

Data on File

Based on Mercury 1 Topline 12-month

Product candidates have not approved by the FDA

For Investor Use

Data on File

Based on Mercury 1 Topline 12-month

Product candidates have not approved by the FDA

For Investor Use

–

Hyperemia severity did not increase with continued dosing

–

Hyperemia was sporadic

•

Only ~10% of patients had hyperemia on each study visit day from

week 2 to month 12 (~7% Rhopressa™, ~3% latanoprost)

–

Only ~8% of all patients discontinued due to hyperemia (~7% of

all patients at Month 3)

Roclatan™ Conjunctival Hyperemia Was Sporadic And

Severity Did Not Increase With Continued Dosing

Consistent statistically superior efficacy over both latanoprost and

Rhopressa™ at all time points demonstrated in 2 Phase 3 trials

(Mercury 1 and Mercury 2)

IOP-lowering effect was greater (1-3 mmHg) than monotherapy

with either latanoprost

or Rhopressa™ throughout the duration of

the study

Stable efficacy through 12 months

Well tolerated with no evidence of treatment-related serious or

systemic effects

Roclatan

Once-Daily Performance Summary

Product candidates have not approved by the FDA

For Investor Use

Data on File

Based on Mercury 1 and Mercury 2

Rhopressa

efficacy similar to latanoprost

with baseline

IOP < 25 mmHg

Rhopressa

maintained consistent IOP lowering across all

baseline IOPs including

25 mmHg

Stable efficacy through 12 months

Adverse event profile consistent with previous studies

Rhopressa

Once-Daily Performance Summary

Product candidates have not approved by the FDA

For Investor Use

Data on File

Based on Mercury 1 Topline 12-month

Rhopressa

•

PDUFA February 28, 2018

•

Expected FDA Advisory Committee

•

Initiating clinical program for Japan market (Phase 1 and 2 to

be conducted in the U.S. in Japanese patients)

•

To commence in Q3/Q4 2017

Roclatan

•

NDA filing expected 1H 2018

•

Mercury 3 (Europe): 6-month study, comparing to Ganfort®

•

To commence in Q3 2017

Key Upcoming Milestones

Product candidates have not approved by the FDA

For Investor Use

Aerie Pharmaceuticals (AERI) 8-KAerie Pharmaceuticals Reports Positive RoclatanTM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% Phase 312-month Topline Safety Results