8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 9, 2017

Aerie Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

Delaware	001-36152	20-3109565
(State or other jurisdiction of incorporation)	(Commission File Number)	(I.R.S. Employer Identification Number)

2030 Main Street, Suite 1500

Irvine, California 92614

(Address of principal executive offices)(Zip code)

Registrant’s telephone number, including area code: (949) 526-8700

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 7.01. Regulation FD Disclosure.

On or after January 9, 2017, representatives of Aerie Pharmaceuticals, Inc. (the “Company”) may present to various investors the information described in the slides attached to this report as Exhibit 99.1 hereto, which is hereby incorporated by reference into this Item 7.01.

The information in this Item 7.01 (including Exhibit 99.1) is being furnished, not filed, pursuant to Regulation FD. Accordingly, the information in this Item 7.01 will not be incorporated by reference into any registration statement filed by the Company under the Securities Act of 1933, as amended, unless specifically identified therein as being incorporated therein by reference. The furnishing of the information in this Item 7.01 is not intended to, and does not, constitute a determination or admission by the Company that this information is material or complete, or that investors should consider this information before making an investment decision with respect to any security of the Company.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

The following exhibit relating to Item 7.01 shall be deemed to be furnished, and not filed:

99.1 Company Overview Presentation dated January 2017.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	AERIE PHARMACEUTICALS, INC.
Date: January 9, 2017	By:	/s/ RICHARD J. RUBINO
		Richard J. Rubino
		Chief Financial Officer

EXHIBIT INDEX

Exhibit	Description
99.1	Company Overview Presentation dated January 2017.

EX-99.1

Company Overview

January 2017

Exhibit 99.1

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. In addition, any discussion of clinical trial results for Rhopressa™ (netarsudil

ophthalmic solution) 0.02% relate to the results in its first Phase 3 registration trials named Rocket 1 and Rocket 2, or

Rocket 4 which will be used primarily for European regulatory filing purposes, and for Roclatan™ (netarsudil/latanoprost

ophthalmic solution) 0.02%/0.005% relate to the results in its Phase 3 registration trial.

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, including the updated guidance presented herein, 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. Any top line data presented herein is

preliminary and based solely on information available to us as of the date of this document and additional information about

the results may be disclosed at any time. In addition, the preclinical research discussed in this presentation is preliminary

and the outcome of such preclinical studies may not be predictive of the outcome of later trials. Any future clinical trial

results may not demonstrate safety and efficacy sufficient to obtain regulatory approval related to the preclinical research

findings discussed in this presentation. 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.

3

Aerie Late Stage IOP–Lowering Products

Pre-Clinical Research

•

Rhopressa™

•

Potential for disease modification and neuroprotection

•

AR-13154

•

Significant lesion size reduction in wet AMD

•

Drug Delivery -

Front and back of the eye

•

Rhopressa™ (netarsudil ophthalmic solution) 0.02%

•

Inhibits ROCK, NET, lowers EVP, targets diseased tissue

•

NDA re-filing expected near end of Q1 2017; entering launch mode

•

Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%

•

Fixed combination of Rhopressa™ and latanoprost

•

Two P3’s in process; first P3 achieved primary efficacy endpoint

Aerie –

Building a Major Ophthalmic

Pharmaceutical Company

Data on file

4

FY 2015 U.S. Glaucoma Market = $2.5B; 34M TRx

Market Share in TRx

PGA Market

Non-PGA Market

2015 US Glaucoma Market

Once Daily

2-3 Times Daily

9%

8%

35%

13%

15%

10%

8%

Bimatoprost

Travoprost

Latanoprost

BB

Fixed Combo

AA

CAI

PGA: Prostaglandin Analogue; BB: Beta Blocker; AA: Alpha Agonist; CAI: Carbonic Anhydrase Inhibitor

Source: IMS MIDAS. IMS NPA

5

~75% of U.S. Glaucoma Patients Have IOPs

that are

25 mmHg at Time of Diagnosis

Baseline IOP*

The Baltimore Eye Survey

60%

20%

20%

21 mmHg

(Normal Tension Glaucoma)

5,308 Individuals Were Screened for the Prevalence of Primary Open-Angle

Glaucoma (POAG) and the IOP at Time of Diagnosis

92% of Japanese Patients with POAG, IOPs Were

21 mmHg**

*

Sommer A, Tielsch JM, Katz J et al. Relationship between intraocular pressure and primary open angle glaucoma among

white

and

black

Americans:

The

Baltimore

eye

survey.

Arch

Ophthalmol

1991;109:1090-1095

**

IWASE et al Tajimi study group. Japan Glaucoma Society. Ophthalmology, 2004 Sep, 111 (9): 1641-8.

25 -

34 mmHg

22 -

24 mmHg

6

Potential drug of choice as

adjunctive therapy to PGAs

when additional IOP lowering

is desired

Potential drug of choice for

patients requiring maximal IOP

lowering

Rhopressa

™

Positioning

Roclatan

™

Positioning 

Rhopressa

TM

and

Roclatan

TM

Potential

Product Advantages

Rhopressa

™

Advantages

•

Efficacy vs. other adjunctive

therapies

•

QD PM dose

•

Lack of serious and systemic

AE’s

Roclatan

™

Advantages

•

Efficacy vs. all other

glaucoma therapies

•

QD PM dose

•

Lack of serious and systemic

AE’s

7

++

Data on file from Aerie Phase 3 clinical trials, Rocket 1, Rocket 2, Rocket 4 and Mercury 1.

Value

of

Rhopressa

TM

++

•

Directed at site of pathology

•

The trabecular meshwork

•

Enhanced compliance

•

Once-a-day dosing

•

Efficacy 

•

Achieves noninferiority to timolol where

AA’s (Brimonidine) and CAI’s failed

•

Consistent IOP lowering across broad

baseline range of Mercury 1

•

Additive to prostaglandins

•

Safety 

•

Lack of serious and systemic adverse

events

8

**Rhopressa

TM

achieves non-inferiority to timolol at primary endpoint range                                

of > 20 mmHg to < 25 mmHg

*Rhopressa

TM

achieves non-inferiority to timolol at pre-specified secondary         

endpoint range of > 20 mmHg to < 24 mmHg; also non-inferior at < 25 mmHg

Rhopressa™ Trials for NDA Resubmission

Near End of Q1 2017

“Rocket 1”

90-Day Efficacy*

Registration Trial

U.S.

“Rocket 1”

90-Day Efficacy*

Registration Trial

U.S.

Rhopressa™ 0.02% QD

202 patients

timolol BID

209 patients

(Total enrollment: 411 patients)

“Rocket 2”

One Year Safety

(3 Mo. Interim

Efficacy**)

Registration Trial

U.S.

“Rocket 2”

One Year Safety

(3 Mo. Interim

Efficacy**)

Registration Trial

U.S.

Rhopressa™ 0.02% QD

251 patients

Rhopressa™ 0.02% BID

254 patients

timolol BID

251 patients

(Total enrollment: 756 patients)

1

Post-hoc analysis

ClinicalTrials.gov Identifier: NCT02207491, NCT02207621

1

9

Rhopressa™ Phase 3 Trial Data to

Supplement NDA Filing

ClinicalTrials.gov Identifier: NCT02246764, NCT02558374

“Rocket 4”

3 Month Efficacy*

6 Month Safety

“Rocket 4”

3 Month Efficacy*

6 Month Safety

Rhopressa™ 0.02% QD

351 patients

timolol BID

357 patients

*Rhopressa™

achieves

non-inferiority

to

timolol

at

primary

endpoint

range

of

>

20

mmHg to < 25 mmHg; also non-inferior at pre-specified range up to < 28 mmHg

“Mercury 1”

One Year Safety

(3 Mo. Interim

Efficacy**)

Registration Trial 

“Mercury 1”

One Year Safety

(3 Mo. Interim

Efficacy**)

Registration Trial 

Roclatan™ QD

238 patients

Rhopressa™ 0.02% QD          

244 patients

Latanoprost QD

236 patients

**Rhopressa™

achieves

non-inferiority

to

latanoprost

at

pre-specified

secondary

endpoint range of > 20 mmHg to < 25 mmHg

10

Rocket 2: 12 Month 8am IOP

Safety Population, Completed Patients (<27 mmHg)

•

Difference in 8am mean IOP from

Day 90 (Month 3) to Month 12:

Rhopressa

TM

QD:

•

Full population: +0.1 mmHg

•

Subset analyses: -0.3 to +0.3 mmHg

Timolol

BID:

•

Full population: +0.5 mmHg

•

Subset analyses: +0.1 to +1.4 mmHg

Day 90

Month 12

AR-13324 0.02% QD

(n=118)

BL

W2

W6

M3

M6

M9

M12

Data

on

file:

Interim

12-month

safety

AR-13324

–

CS302

11

Rocket 2: Safety/Tolerability Overview of

Rhopressa™

QD

(Interim

12-Month)

*  Incidence of conjunctival hyperemia ~50% including baseline at ~20%

•

There

were

no

drug-related

serious

adverse

events

(SAEs)

•

No

new

adverse

events

introduced

over

the

twelve-month

period

•

The

most

common

adverse

event

was

conjunctival

hyperemia

with

~50%

incidence*,

the

majority

mild

•

Other

ocular

AEs

•

AEs

occurring

in

~5-23%

of

patients

included:

conjunctival

hemorrhage,

corneal

verticillata,

blurry

vision

and

reduced

visual

acuity

12

Rhopressa™

QD Adverse Events Summary

Data on File: Interim 12-month safety AR-13324-CS302

Hyperemia

–

absent

or

sporadic

for

~90%

of

patients

-

~10% of patients had hyperemia AE at all 6 study visits 

Conjunctival

Hemorrhage

–

sporadic

subconjunctival

petechiae

-

none noted at month 12 visit       

Corneal

Verticillata

–

asymptomatic

non-toxic

lipid

deposits      

-

high resolution rate         

Visual

Acuity

Reduced

–

sporadic,

mostly

single

visit,

only

one

eye        

-

incidence reduced over time

Vision

Blurred

–

sporadic

and

significantly

reduced

over

12

months

When Present, 80% of Rhopressa

QD

Hyperemia Graded as Mild*

Data

on

File:

AR-13324

–

CS302

TM

Grade

Image

Description

0

None/Normal

1

Mild

2

Moderate

3

Severe

For illustrative purposes only

13

14

Rhopressa™ 24-hour IOP Pilot Study

Demonstrates Effective Nocturnal Efficacy

(n=8)

(n=8)

**

**

**

***

**

**

***

***

**

p<0.01

***

p<0.001

•

Netarsudil

(active ingredient of Rhopressa™) equally effective during

nocturnal and diurnal periods

•

Current glaucoma medications either have no efficacy at night (beta

blockers,

alpha

agonists)

or

reduced

efficacy

at

night

(PGAs,

CAIs)

1

-

6

Data on File: AR-13324-CS204

1.

Liu JH, et al. Am J Ophthalmol. 2004; 138:389-395.  2. Gulati V, et al.  Arch Ophthalmol. 2012; 130:677-684. 3.  Liu JH, et al. Ophthalmology. 2009; 116:449-

454.  4. Liu JH, et al. Ophthalmology. 2010; 117:2075-9.  5. Fan S et al. J Glaucoma.  2014; 23:276-81.  6. Liu JH, et al. Am J Ophthalmol. 2016;169:249-257.

Roclatan™ Registration Trial Design

Roclatan™ QD

~230 patients

Rhopressa™ 0.02% QD

~230 patients

latanoprost QD

~230 patients

Roclatan™ QD

~230 patients

Comparator (TBD)

~230 patients

*    ClinicalTrials.gov Identifier: NCT02558400

**   ClinicalTrials.gov Identifier: NCT02674854

Roclatan™ QD

238 patients

Rhopressa™ 0.02% QD

244 patients

latanoprost QD

236 patients

“Mercury 1”*

One Year Safety

(3 Mo. Interim

Efficacy)

Registration Trial

U.S.

“Mercury 2”**

90-Day Efficacy

Registration Trial

U.S. and Canada

“Mercury 3”

6 Mo. Efficacy and

Safety

Registration Trial 

Europe

15

16

•

Roclatan™ met the criteria for demonstrating statistical superiority

over both latanoprost and Rhopressa™ for the primary efficacy

analysis

•

IOP-lowering effect of Roclatan™ was greater (1-3 mmHg) than

monotherapy with either latanoprost or Rhopressa™ throughout the

duration of the study

•

Roclatan

reduced mean diurnal IOPs to 16 mmHg or lower in 61%

of patients, a significantly higher percentage than observed in the

comparator arms

•

The Rhopressa

arm achieved non-inferiority to latanoprost in the

pre-specified range of >20 mmHg to <25 mmHg

Mercury 1: Roclatan

Achieves Primary

Clinical Endpoint

Data on file and PG324 -

CS301 Top Line Data

TM

TM

TM

17

Roclatan™

Achieved Statistical Superiority Over

Individual Components at All 9 Time Points

Mean IOP at Each Time Point  (ITT)

***p<0.0001 vs Latanoprost and Rhopressa™

++

Data on File

Based on Mercury 1 Topline Interim 3-month

18

Mercury 1: Roclatan

Phase 3 Responder

Analysis

***

***

***

***p<0.0001 vs Latanoprost and Rhopressa

###

p<0.0001 vs

Rhopressa

, p<0.05 vs Latanoprost

Data on file and PG324 -

CS301 Top Line Data

Day 90:  % of Patients with IOP Reduced to 18 mmHg or Lower

14%

23%

32%

42%

54%

15%

25%

39%

54%

69%

33%

44%

61%

71%

82%

0%

20%

40%

60%

80%

100%

14 mmHg

15 mmHg

16 mmHg

17 mmHg

18 mmHg

IOP on Treatment

Rhopressa™ (n=198)

Latanoprost

(n=223)

Roclatan™ (n=200)

###

###

TM

TM

TM

19

Mercury 1: Safety/Tolerability Overview of

Roclatan

•

There were no drug-related serious adverse events

(SAEs)

•

There was no evidence of treatment-related systemic

effects

•

The most common adverse event was conjunctival

hyperemia with ~50% incidence*, ~80% mild on

biomicroscopy

•

Other ocular AEs

–

AEs occurring in ~5-11% of subjects receiving Roclatan

included: conjunctival hemorrhage, eye pruritus, lacrimation

increased and cornea verticillata.

* Incidence of conjunctival hyperemia ~50% including baseline at ~20%

Data on file and PG324 -

CS301 Top Line Data

TM

TM

20

Expanding Aerie Franchise to Europe and Japan

•

Europe

•

Current clinical plan expected to satisfy EU regulatory requirements

(including Rocket 4 for Rhopressa

and Mercury 3 for Roclatan

TM

)

•

Establishing KOL relationships in top 5 countries

•

Currently developing EU commercialization strategy

•

Expect to file EU MAA for Rhopressa™ near year-end 2017

•

Japan

•

Discussions regarding potential Rhopressa™

out-licensing are ongoing

•

Also preparing to advance clinical development on our own / with CRO

•

Conferring with PMDA to confirm path to approval

TM

21

Advancing Earlier-Stage Pipeline

Data on file

•

Rhopressa™

•

Potential for disease modification

•

AR-13154

•

Significant lesion size reduction in wet AMD

•

Drug Delivery

•

Rhopressa™: Front of the eye

•

AR-13154: Back of the eye

22

Netarsudil* Causes Expansion of TM Tissue,

Opening Spaces for Increased Outflow

Dan Stamer (Duke), Haiyan Gong (Boston University)

Control

+ Netarsudil

TM: Trabecular Meshwork

SC: Schlemm’s

Canal

Control = buffered saline solution

*Active ingredient of Rhopressa™

Source:

The

Mechanisms

of

Increasing

Outflow

Facility

by

AR-13324M

in

Human

Eyes.

Haiyan

Gong,

Ruiyi

Ren,

Guorong

Li,

Casey

Kopczynski, Daniel Stamer

Increasing Trabecular

Outflow, Reducing Fibrosis Could Stop

Degeneration of Outflow Tissues in Glaucoma

23

Rhopressa

TM

Blocks TGF-beta-Induced Expression

of Fibrosis Proteins in Cultured Human TM Cells

P. Vasantha Rao, Duke University

•

TGF

2: Transforming growth factor

2; SMA: Smooth muscle actin; FSP1: Fibroblast-specific protein 1

•

Pattabiraman,

Padmanabhan

P.,

et.

Al.,

(2015

AOPT

Meeting)

“Effects

of

Rho

Kinase

inhibitor

AR-13324

on

actin

cytoskeleton

and

TGF

2

and

CTGF-

induced

fibrogenic

activity

in

Human

Trabecular

Meshwork

Cells”.

TGF-beta Levels are Elevated in the Aqueous Humor of    

Patients with Glaucoma

Control 

TGF

2 (8ng/ml)

TGF

2 (8 ng/ml) +

AR-13324* (500nM)

24

Live Imaging of Rhopressa

-induced

Increase in Trabecular Meshwork Outflow

Rhopressa

TM

-induced increase in trabecular outflow of aqueous

humor visualized in real time using live-animal OCT imaging in mice

•

First study to show glaucoma drug affecting target tissue in real time

Rhopressa

TM

Treatment

Blue shading shows Schlemm’s Canal expanding due to enhanced fluid flow through TM

Rhopressa

TM

Li G. et al. Visualization of conventional outflow tissue responses to netarsudil in living mouse eyes.

Eur J Pharmacol. 2016 Apr 13. pii: S0014-2999(16)30206-0

before

after

0

0.5

1

1.5

2

intensity

area

TM

25

AR-13154 is ROCK Inhibitor with Additional

Activity Against PKC, PDGFR and JAK Kinases

•

182 Aerie compounds

screened against 469

human kinases

•

AR-13154 identified as lead

compound to address:

•

Vascular dysfunction 

ROCK, PKC, PDGFR

•

Fibrosis                     

ROCK, PKC, PDGFR

•

Inflammation              

ROCK, JAK

Relationship tree of human kinases.  TK, TKL, STE, CK1, AGC, CAMK, CMGC, Other: Kinase superfamilies

ROCK

26

Topical AR-13154(S) Provides Additive

Efficacy to

Eylea® in Proliferative Diabetic Retinopathy Model

-37%

-34%

-57%

**

***

***

***

Oxygen-induced

retinopathy model of

PDR (mouse)

0.06% AR-13154(S)

delivered topically

from P12 to P17

Eylea

®

delivered IP

Confirms AR-13154(S)

potential as

monotherapy and as

adjunct to anti-VEGF

therapies

Data on file; Effectiveness of AR-13154 Monotherapy and Combination Therapy in Animal Models of Wet Age-related Macular

Degeneration and Proliferative Diabetic Retinopathy. Cheng-Wen Lin, Jill M. Sturdivant, Mitchell A. deLong and Casey C. Kopczynski

120%

100%

80%

60%

40%

20%

0%

Vehicle Control

(n=55)

AR-13154(S)

topical

(n=28)

Eylea

1mg/kg IP (n=26)

AR-13154(S) +

Eylea (n=18)

Total Neovascular

Area

27

AR-13154 Efficacy Driven Primarily by ROCK,

PKC Inhibition in Retina

Retinal tissue

harvested from OIR

mouse model

AR-13154 effectively

converted to active

metabolite by

esterases

Active metabolite

keeps ROCK, PKC

activity, loses

PDGFR, JAK activity

Retinal

Esterases

X

AR-13154

Active

Inactive

Data on file; Effectiveness of AR-13154 Monotherapy and Combination Therapy in Animal Models of Wet Age-related Macular

Degeneration and Proliferative Diabetic Retinopathy. Cheng-Wen Lin, Jill M. Sturdivant, Mitchell A. deLong and Casey C. Kopczynski

ROCK  JAK

PKC PDGFR

ROCK

PKC

Products in Development: Preclinical

•

Netarsudil* sustained-release implant for Glaucoma

•

Single

injection

to

lower

IOP

for

3

–

6

months

•

Potential for increased efficacy, reduced ocular            

side effects, neuroprotection

•

Addresses problem of patient adherence to daily drops

and gives control to the physician

•

AR-13154 implant for AMD, DR/DME

•

ROCK/PKC/PDGFR/JAK multi-kinase inhibitor

•

Addresses multiple drivers of disease -

fibrosis,

inflammation, vessel leakage and neovascularization

•

Efficacy demonstrated as monotherapy and                    

as adjunct to anti-VEGF therapy (preclinical)

•

Potential to improve long-term outcomes

* Active ingredient of Rhopressa™

28

29

Summary

•

Key Clinical Priorities

•

Rhopressa

TM

: NDA resubmission expected near end of Q1 2017

•

Research Initiatives

•

Rhopressa™

disease modification, neuroprotection, sustained release    

•

AR-13154 potential in wet AMD, etc.

•

Evaluating Aerie’s 3,000+ proprietary molecules

•

Business Development and Expansion Opportunities

•

Drug delivery opportunities for front and back of the eye

•

EU/JP clinical path and commercialization strategy

•

Ireland Manufacturing Facility

•

Fully Financed*

Rocket 4 completion

Mercury 3 commencement 1H 2017 (EU)

Mercury 1 and Mercury 2 completion

•

Roclatan

TM

:

* $255.6 million in cash and investments at 9/30/16

2016

2017

Rhopressa™ and Roclatan™

Key Milestones

30

Q3-2017: Roclatan™

P3 Mercury 1

Topline safety (12 mos)

Near YE 2017: Roclatan™

NDA filing expected

1H-2017: Roclatan™

P3 Mercury 3 (EU)

to be initiated

Q1-2016: Rhopressa™

Rocket 2 Topline safety (12 mos)

Near End of Q1-2017:

Rhopressa™ NDA re-filing

expected

Q4-2016: Rhopressa™

Rocket 4 Topline efficacy (3 mos)

Q3-2016: Roclatan™

P3 Mercury 1

Topline efficacy (3 mos)

Q2-2017: Roclatan™

P3 Mercury 2

Topline efficacy (3 mos)

Q1-2016: Roclatan™

P3

Mercury

2

initiated

Q2-2017: Rhopressa™

Rocket 4 Topline safety  (6 mos)