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): April 23, 2015

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 April 23, 2015, Aerie Pharmaceuticals, Inc. (the “Company”) issued a press release announcing the results from the Company’s first Phase 3 registration trial of Rhopressa^TM, (“Rocket 1”). A copy of the press release is furnished as Exhibit 99.1 hereto and is hereby incorporated by reference into this Item 7.01.

On or after April 23, 2015, representatives of the Company may present to various investors the information about the results of Rocket 1 described in the slides attached to this report as Exhibit 99.2 hereto, which is hereby incorporated by reference into this Item 7.01.

The information in this Item 7.01 (including Exhibits 99.1 and 99.2) 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 exhibits relating to Item 7.01 shall be deemed to be furnished, and not filed:

99.1	Press Release dated April 23, 2015.
99.2	RhopressaTM Phase 3 “Rocket 1” Results dated April 23, 2015.

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: April 23, 2015	By:	/s/ Richard J. Rubino
		Richard J. Rubino
		Chief Financial Officer

EXHIBIT INDEX

Exhibit	Description
99.1	Press Release dated April 23, 2015.
99.2	RhopressaTM Phase 3 “Rocket 1” Results dated April 23, 2015.

EX-99.1

Exhibit 99.1

Aerie Pharmaceuticals Reports Initial Rhopressa^TM Phase 3 Efficacy Results

Conference Call and Webcast Today, April 23 at 5:00 p.m. ET

IRVINE, Calif. & BEDMINSTER, NJ & RESEARCH TRIANGLE PARK, N.C., April 23, 2015 —(BUSINESS WIRE)— Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye, today reported the results of its first Phase 3 registration trial (Rocket 1) for Rhopressa^TM, a novel once-daily, triple-action eye drop being tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. The trial did not meet its primary efficacy endpoint of demonstrating non-inferiority of IOP lowering for once-daily Rhopressa^TM compared to twice-daily timolol, the most widely used comparator in registration trials for glaucoma. However, Rhopressa^TM demonstrated non-inferiority compared to timolol for patients in the study with IOP below 26 millimeters of mercury (mmHg) at all nine measured time points and numerical superiority over timolol at the majority of measured time points. As discussed below, approximately 80% of glaucoma patients have IOP of 26mmHg or less at the time of diagnosis. Management will host a conference call to discuss these results at 5:00 p.m. ET today.

Triple-Action Rhopressa^TM Phase 3 Highlights for Rocket 1

• Rhopressa^TM did not meet its primary efficacy endpoint of demonstrating non-inferiority of IOP lowering for Rhopressa^TM compared to twice-daily timolol, based upon IOP measurements at the end of week 2, week 6 and day 90. The Rocket 1 study included 182 patients in the Rhopressa^TM once-daily arm and 188 patients in the timolol twice-daily arm. The baseline IOPs tested in the study ranged from above 20 to below 27 mmHg. In addition, the results showed a slight loss of efficacy in the week 6 and day 90 measurements. Across the Rhopressa^TM study of 182 patients, 36 patients or approximately 20 percent showed signs of loss of efficacy during the study. The primary adverse event was hyperemia, which was experienced by approximately 35 percent of the Rhopressa^TM patients, of which 80 percent was reported as mild.

• Based on further analysis, Rhopressa^TM demonstrated non-inferiority compared to timolol for patients in the study with IOPs below 26mmHg at all nine measured time points and numerical superiority over timolol at the majority of measured time points. The Baltimore Eye Survey points to approximately 80 percent of newly diagnosed glaucoma patients having IOPs of 26mmHg or less. In addition, Rhopressa^TM demonstrated, in a pre-specified analysis, non-inferiority to timolol and numerical superiority over timolol at all nine measured time points for patients in the study with IOPs below 24mmHg. We also noted that the number of Rhopressa^TM patients that experienced loss of efficacy over time was reduced to half for patients with IOPs less than 26mmHg, and the frequency of such occurrence progressively decreased for Rhopressa^TM patients with lower IOPs.

“We are obviously disappointed that we missed the primary endpoint for Rocket 1. We expected Rhopressa^TM to demonstrate better performance based on the results we saw in the previous Phase 2b studies. However, if we had set the high end of the baseline range just one mmHg less, we would have demonstrated non-inferiority compared to timolol at all nine measured time points and numerical superiority at the majority of time points. We believe Rhopressa^TM shows great promise at IOPs where the majority of patients are represented. Also, we believe the meaningful decrease in the number of patients that experienced efficacy loss at the lower baseline IOPs supports the potential benefit of the Rhopressa^TM on episcleral venous pressure,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer of Aerie.

Dr. Anido continued, “We look forward to our Rocket 2 efficacy results expected in the third quarter and twelve month safety results expected by the end of 2015. Rocket 2 results are expected to inform our future strategies, including the potential need for an additional Rhopressa^TM Phase 3 registration trial. In addition, we are well prepared to commence the quadruple-action Roclatan^TM Phase 3 trials later in 2015. As of the end of the first quarter 2015, we had over $179 million of cash and investments on our balance sheet, and are well-financed to proceed with our key strategies.”

Triple-Action Rhopressa™

Rhopressa^TM is a novel triple-action eye drop that we believe, if approved, would become the only once-daily product available that specifically targets the trabecular meshwork, the eye’s primary fluid drain and the diseased tissue responsible for elevated IOP in glaucoma. Preclinical results have demonstrated that Rhopressa^TM also lowers episcleral venous pressure, which contributes approximately half of IOP in healthy subjects. Further, Rhopressa^TM provides an additional mechanism that reduces fluid production in the eye and therefore lowers IOP. Biochemically, Rhopressa^TM is known to inhibit both Rho Kinase (ROCK) and norepinephrine transporter (NET).

There are three Phase 3 registration trials for Rhopressa^TM, “Rocket 1,” a 90-day efficacy trial, the results of which are reported in this press release, “Rocket 2,” a 12-month safety trial with a 90-day interim efficacy readout expected third quarter 2015, and “Rocket 3,” a safety-only study being conducted in Canada. Pending successful results from the remaining Phase 3 registration trials and a potential additional Phase 3 registration trial for Rhopressa^TM, the Company expects to submit a New Drug Application filing by the end of 2016.

Conference Call / Web Cast Information

Aerie management will host a live conference call and webcast at 5:00 p.m. Eastern Time today to discuss the Rhopressa^TM Phase 3 efficacy results from Rocket 1.

The live webcast and a replay may be accessed by visiting Aerie’s website at http://investors.aeriepharma.com. In addition, a presentation regarding the Rhopressa^TM Rocket 1 results will be discussed on the conference call and are posted to the website. Please connect to the Company’s website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (888) 734-0328 (U.S.) or (678) 894-3054 (international) to listen to the live conference call. The conference ID number for the live call is 33582962. Please dial in approximately 10 minutes prior to the call. Telephone replay will be available approximately two hours after the call. To access the replay, please call (855)-859-2056 (U.S.) or (404) 537-3406 (international). The conference ID number for the replay is 33582962. The telephone replay will be available until April 29, 2015.

About Aerie Pharmaceuticals, Inc.

Aerie is a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye. The Company is conducting a Phase 3 registration trial in the United States, named “Rocket 2,” where the primary efficacy endpoint will be to demonstrate non-inferiority of IOP lowering for Rhopressa^TM compared to timolol, along with a Phase 3 registration safety-only trial, named “Rocket 3,” in Canada. The Company recently completed its initial Phase 3 registration trial, “Rocket 1,” the three-month efficacy results of which are reported in this press release. The Company also completed a Phase 2b clinical trial in which Roclatan^TM met the primary efficacy endpoint, demonstrating the statistical superiority of Roclatan^TM to each of its components.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “exploring,” “pursuing” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the success, timing and cost of our ongoing and anticipated preclinical studies and clinical trials for our current product candidates, including statements regarding the timing of initiation and completion of the studies and trials; our expectations regarding the clinical effectiveness of our product candidates and results of our clinical trials; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, our product candidates; our expectations regarding the commercialization of our product candidates; our expectations related to the use of proceeds from our initial public offering and the issuance and sale of our senior secured convertible notes; our estimates regarding anticipated capital requirements and our needs for additional financing; the potential advantages of our product candidates; our plans to pursue development of our product candidates for additional indications and other therapeutic opportunities; our plans to explore possible uses of our existing proprietary compounds beyond glaucoma; and our ability to protect our proprietary technology and enforce our intellectual property rights. By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics and industry change, and depend on regulatory approvals and economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. We discuss many of these risks in greater detail under the heading “Risk Factors” in the quarterly and annual reports that we file with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Contacts

Aerie Pharmaceuticals

Richard Rubino, 908-947-3540

rrubino@aeriepharma.com

or

Burns McClellan, Inc., on behalf of Aerie Pharmaceuticals

Investors

Ami Bavishi, 212-213-0006

abavishi@burnsmc.com

or

Media

Justin Jackson, 212-213-0006

jjackson@burnsmc.com

Source: Aerie Pharmaceuticals, Inc.

EX-99.2

1

Rhopressa

TM

(ROCK-NET Inhibitor)

Rho Kinase Elevated Intraocular Pressure Treatment Trial

(Rocket 1) Phase 3 Topline Results

1

Exhibit 99.2

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 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.

3

Background

There are three Phase 3 registration trials for Rhopressa

TM

, “Rocket 1,”

a 90-day efficacy trial, the results of which are reported in this

presentation, “Rocket 2,”

a 12-month safety trial with a 90-day interim

efficacy readout expected third quarter 2015, and “Rocket 3,”

a safety-

only study being conducted in Canada.

Rocket 1 clinical trial evaluated

•

the

ocular

hypotensive

efficacy

of

Rhopressa

TM

0.02%,

dosed

QD,

versus Timolol, 0.5%, dosed BID, in patients with elevated

intraocular pressure (OAG and OHT) for 90 days

•

the

ocular

and

systemic

safety

of

Rhopressa

TM

,

0.02%

for

90

days

4

4

Patients randomized

1:1

Primary endpoint: Mean IOP at

Weeks 2 and 6 and Day 90

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

with IOP >20 mmHg and < 27 mmHg

N=411 randomized at 36 sites

(370 subjects per protocol)

Timolol 0.5%

BID

Rhopressa

TM

Rocket 1 Trial Design

Rhopressa

TM

0.02% QD (PM)

5

Study Endpoints

Efficacy:

•

The primary efficacy endpoint is the mean IOP at the following time

points: 08:00, 10:00, and 16:00 at the Week 2, Week 6, and Day 90

visits

•

Secondary efficacy endpoints include

•

IOP analysis stratified by baseline IOP above and below 24 mmHg

•

Mean change from baseline IOP

•

Mean percent change from diurnally adjusted baseline IOP

•

Mean diurnal and change from baseline diurnal IOP

Safety:

•

Ocular and systemic safety measures

6

Trial Conduct

Number

of

Patients

Randomized

-

411

Number

of

Early

Terminations

–

44

(Combined

Rhopressa

TM

and

Timolol)

31 in Rhopressa

TM

, 13 in Timolol

Major

Reasons

for

Early

Termination

(Combined

Rhopressa

TM

and

Timolol)

Adverse events (55%)

Protocol violation (18%)

Withdrawal of consent (11%)

Lack of efficacy (7%)

Investigator decision (4%)

7

Primary Endpoint: Topline Summary

Per Protocol population (baseline IOP < 27 mmHg)

Rhopressa

TM

did

not

meet

criteria

for

non-inferiority

to

Timolol

Rhopressa

TM

mean

difference

from

Timolol

ranged

from

–0.4

to

+1.3 mmHg

Inferiority

was

driven

by

a

subset

of

Rhopressa

TM

patients

losing

efficacy over time (~ 20%)

8

Rhopressa

TM

Rocket 1, Per Protocol

* Missed upper 95% CI criteria (<1.5 mmHg)

Baseline IOP < 27 mmHg at all time points

TM

Baseline

8 AM

23.4

23.4

10 AM

22.3

21.9

4 PM

21.8

21.5

Day 15

8 AM

18.7

18.3

0.4

(-0.3, 1.0)

10 AM

17.3

17.6

-0.3

(-0.9, 0.4)

4 PM

17.2

17.7

-0.5

(-1.1, 0.2)

Day 43

8 AM

19.4

18.2

1.1

(0.4, 1.8)*

10 AM

18.1

17.4

0.7

(0.0, 1.4)

4 PM

17.9

17.7

0.2

(-0.5, 0.8)

Day 90

8 AM

19.8

18.5

1.3

(0.6, 2.0)*

10 AM

18.9

18.0

1.0

(0.3, 1.7)*

4 PM

18.5

17.7

0.7

(0.1, 1.4)

(95% CI)

Timolol

Rhopressa

–

Mean IOP

Rhopressa

TM

N=182

Timolol

N=188

Mean

Difference

95% CI

9

Mean Baseline IOP < 27 mmHg at All Time Points

10

Rhopressa

TM

Subjects With Decreasing Efficacy

Over Time

(Decreasing efficacy over time defined as greater than 3 mmHg)

Correlation With Entry Baseline IOP

Possible explanations for “drifter”

subjects

n= number of subjects per protocol

•

Severe trabecular meshwork damage (e.g. duration of disease)

•

Dosing compliance

•

Concomitant medications

•

<27 mmHg –

36 drifters (n=182, 19.8%)

•

<26 mmHg –

18 drifters (n=133, 13.5%)

•

<24 mmHg –

5 drifters  (n=76, 6.6%)

11

Lower baseline populations (IOP < 26 mmHg and IOP < 24 mmHg)

IOP

<

26

mmHg

cohort

(n=277),

Rhopressa

TM

met

non-inferiority

criteria at all 9 time points and was numerically superior to Timolol

at the majority of time points

IOP

<

24mmHg

cohort

(n=160),

Rhopressa

TM

met

non-inferiority

criteria at all 9 time points and was numerically superior to Timolol

at all 9 time points (Pre-specified analysis)

Subjects with loss of efficacy reduced by 50% in baseline IOP < 26

mmHg cohort and by 86% in baseline IOP < 24 mmHg

Topline Summary (Lower Baseline IOP)

12

Rhopressa

TM

Rocket 1, Baseline IOP < 26 mmHg

Rhopressa

TM

met non-inferiority criteria at all time points and

numerical superiority at majority of time points

Baseline

8 AM

22.7

22.8

10 AM

21.7

21.3

4 PM

21.0

20.8

Day 15

8 AM

17.8

18.0

-0.2

(-0.8,0.4)

10 AM

16.5

17.1

-0.6

(-1.2,0.0)

4 PM

16.4

17.3

-0.9

(-1.5,-0.2)

Day43

8 AM

18.3

17.9

0.4

(-0.3,1.1)

10 AM

17.3

17.1

0.2

(-0.5,0.8)

4 PM

17.0

17.4

-0.4

(-1.1,0.3)

Day 90

8 AM

18.8

18.3

0.5

(-0.2,1.3)

10 AM

17.9

17.7

0.2

(-0.5,0.9)

4 PM

17.4

17.4

-0.01

(-0.7,0.6)

Mean IOP

Rhopressa

TM

N=133

Timolol

N=144

Rhopressa

(95% CI)

Timolol

–

TM

Mean

Difference

95% CI

13

Baseline IOP < 26 mmHg

14

Rhopressa

TM

Rocket 1, Baseline IOP < 24 mmHg

Rhopressa

TM

met

non-inferiority

criteria

at

all

9

time

points

was

numerically superior to Timolol at all 9 time points

(Pre-specified analysis)

Baseline

8 AM

21.8

21.9

10 AM

20.7

20.6

4 PM

20.2

20.1

Day 15

8 AM

16.7

17.3

-0.6

(-1.3, 0.1)

10 AM

15.6

16.8

-1.2

(-1.9, -0.4)

4 PM

15.6

16.9

-1.4

(-2.1, -0.7)

Day 43

8 AM

17.2

17.4

-0.2

(-0.9, 0.6)

10 AM

16.3

16.8

-0.4

(-1.2, 0.3)

4 PM

15.9

16.8

-0.9

(-1.7, -0.1)

Day 90

8 AM

17.3

17.6

-0.3

(-1.0, 0.5)

10 AM

16.6

16.9

-0.3

(-1.1, 0.5)

4 PM

16.7

17.0

-0.3

(-1.1, 0.5)

Mean IOP

Rhopressa

TM

N=76

Timolol

N=84

Mean

Difference

95% CI

(95% CI)

Timolol

–

TM

Rhopressa

15

Baseline IOP < 24 mmHg (Pre-specified analysis)

16

Safety/Tolerability Overview of Rhopressa

TM

(Days 15-90)

There were no drug-related serious adverse events (SAEs)

The most common adverse event was conjunctival hyperemia

•

Conjunctival hyperemia measured by biomicroscopy at 8am was

~35% of which 80% was mild

Adverse events occurring in approximately 5-13% of the subjects

receiving

Rhopressa

TM

included:

conjunctival

hemorrhage,

erythema

of

the eyelid, blurry vision and corneal deposits

17

Next Steps

Rocket 2 efficacy results (expected in Q3 2015) important in

determining the next steps, which may include the need for an

additional

Rhopressa

TM

registration

trial

Expect

to

file

the

Rhopressa

TM

NDA

by

the

end

of

2016,

if

additional

trial is required

Expect

to

commence

Roclatan

TM

Phase

3

registration

trials

by

the

end

of 2015, after review of Rocket 2 results

Over $179 million on the balance sheet as of the end of Q1 2015.

We

are well financed to execute our strategies