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): June 15, 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 June 15, 2015, Aerie Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration has agreed to allow the Company to change the primary endpoint range of its second Phase 3 registration trial of Rhopressa^™, named Rocket 2. 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 June 15, 2015, representatives of the Company may present to various investors the information relating to its clinical trial programs as 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 June 15, 2015.

99.2 Clinical Trial Update dated June 15, 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: June 15, 2015	By:	/s/ Richard J. Rubino
		Richard J. Rubino
		Chief Financial Officer

EXHIBIT INDEX

Exhibit	Description
99.1	Press Release dated June 15, 2015.
99.2	Clinical Trial Update dated June 15, 2015.

EX-99.1

Exhibit 99.1

Aerie Pharmaceuticals Receives Positive Feedback from FDA

-Rocket 2 Primary Endpoint Range Modified upon FDA Agreement-

Conference Call and Webcast Today, June 15, at 5:00 p.m. ET

IRVINE, California - (BUSINESS WIRE)—Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) (the “Company”), 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 that the U.S. Food and Drug Administration (FDA) has agreed in written and verbal communications that Aerie may change the primary endpoint range of its second Phase 3 registration trial of Rhopressa^TM, named Rocket 2. With this agreement, the Company is changing the primary endpoint range to include patients with baseline intraocular pressures (IOPs) ranging from above 20 mmHg (millimeters of mercury) to below 25 mmHg. The former range for the primary endpoint of above 20mmHg to below 27 mmHg will now represent a secondary endpoint range for Rocket 2.

Highlights

• The Rocket 2 primary endpoint range is now changed to the same range where the Phase 3 registration trial results of Rocket 1 demonstrated success, ranging from above 20 mmHg to below 25 mmHg. In the Rocket 1 trial, in this range, Rhopressa^TM demonstrated non-inferiority to timolol, and numerical superiority over timolol at the majority of time points. According to the Baltimore Eye Survey, nearly 80 percent of newly diagnosed glaucoma patients have unmedicated baseline IOPs below 26 mmHg.

• The FDA also agreed that the Company may use a hierarchically-based statistical approach in determining whether this three-arm trial is adequately powered at the revised primary endpoint range. Using this methodology, the Company believes that the new primary endpoint range is adequately powered, and there is no need to recruit additional patients into Rocket 2. Three-month efficacy results for Rocket 2 are expected by the end of the third quarter of 2015.

• An additional Rhopressa^TM Phase 3 registration trial, named Rocket 4, is expected to commence in the third quarter of 2015, along with the first Roclatan^TM Phase 3 registration trial, named Mercury 1.

“We are extremely pleased with the outcome of our communications with the FDA. If Rocket 2 results resemble those of Rocket 1, we believe we may have a much greater opportunity for success in meeting the clinical endpoint of non-inferiority to timolol. We are also very appreciative of the thoughtful guidance provided by the FDA, and believe their feedback will prove very useful as our programs progress. Looking ahead, we expect to commence our next Phase 3 registration trial for Rhopressa^TM, named Rocket 4, in the third quarter of 2015. Rocket 4 is expected to be established with a primary endpoint range of above 20 mmHg to below 25 mmHg,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer.

Dr. Anido continued, “We are also preparing to commence our first Phase 3 registration trial for Roclatan^TM, named Mercury 1, in the third quarter of 2015. We believe the apparent synergies we observed in Rocket 1 for Rhopressa^TM trial patients previously on prostaglandin analogues such as latanoprost may explain why the Roclatan^TM Phase 2b results were so impressive. If successful in the Phase 3 registration trials, we believe this once-daily quadruple-action product candidate has the potential to be the most efficacious eye drop in the market for patients with glaucoma and ocular hypertension.”

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 (TM), 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 (EVP), 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 were originally three Phase 3 registration trials for Rhopressa^TM. “Rocket 1” was a 90-day efficacy trial, the results of which were initially reported on April 23, 2015, “Rocket 2” is a 12-month safety trial with a 90-day interim efficacy readout, and “Rocket 3” is a safety-only study being conducted in Canada. In Rocket 1, for the primary endpoint range of above 20 mmHg to below 27 mmHg, Rhopressa^TM did not demonstrate non-inferiority to timolol. However, Rhopressa^TM did demonstrate non-inferiority to timolol at all ranges below 26 mmHg. As a result, the Company plans to commence in the third quarter of 2015 an additional Phase 3 registration trial, named “Rocket 4”. Based on the current clinical trial status, the Company may submit a New Drug Application filing in the second half of 2016.

Quadruple-Action Roclatan™

Roclatan™ is a once-daily eye drop that combines our triple-action Rhopressa™ with latanoprost, a prostaglandin analogue that is the most widely prescribed glaucoma drug. If approved, we believe that Roclatan™ would be the first glaucoma product to lower IOP through all known mechanisms: (i) increasing fluid outflow through the TM, the eye’s primary drain, (ii) increasing fluid outflow through the uveoscleral pathway, the eye’s secondary drain, (iii) reducing fluid production in the eye, and (iv) reducing EVP.

A successful 28-day Phase 2b clinical trial for Roclatan™ was completed in June 2014. Roclatan^TM achieved its primary efficacy endpoint on day 29 and demonstrated statistical superiority over the product’s individual components at all time points. We believe that Roclatan™, if approved, would be the only glaucoma product that covers the full spectrum of known IOP-lowering mechanisms, giving it the potential to provide a greater IOP-lowering effect than any currently approved glaucoma product. The first Phase 3 registration trial for Roclatan^TM, “Mercury 1,” is expected to commence in the third quarter of 2015. The Company expects to commence two additional Mercury trials in 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 Company’s clinical trials and provide a general business update.

The live webcast and a replay may be accessed by visiting the Company’s website at http://investors.aeriepharma.com. 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 67259440. 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 67259440. The telephone replay will be available until June 21, 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 currently conducting a Phase 3 registration trial in the United States named Rocket 2, where the primary efficacy endpoint is 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, named Rocket 1, the three-month efficacy results of which were initially reported in April 2015, and expects to commence a fourth Phase 3 registration trial, named Rocket 4, in the third quarter of 2015. The Company also completed in 2014 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, and plans to commence the first Phase 3 registration trial for Roclatan^TM, named Mercury 1, in the third quarter of 2015.

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 and the issuance and sale of shares of our common stock in connection with our “at-the-market” sales agreement; 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

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