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): September 15, 2021

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)

4301 Emperor Boulevard, Suite 400

Durham, North Carolina 27703

(Address of principal executive offices) (Zip code)

Registrant’s telephone number, including area code: (919) 237-5300

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:

☐ 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))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.001 per share	AERI	Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01. Regulation FD Disclosure.

On September 15, 2021, Aerie Pharmaceuticals, Inc. (the “Company”) issued a press release announcing positive topline results of its Phase 2b clinical study, named COMET-1, for AR-15512 (TRPM8 Agonist) (“AR-15512”) ophthalmic solution for the treatment of patients with dry eye disease. A copy of this press release is furnished as Exhibit 99.1 hereto and is hereby incorporated by reference into this Item 7.01.

On or after September 15, 2021, representatives of Aerie Pharmaceuticals, Inc. (the “Company”) may present to various investors the information about the Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease Study AR-15512-CS201 (COMET-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 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	Press Release Dated September 15, 2021
99.2	A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease Study AR-15512-CS201 (COMET-1)
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

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: September 15, 2021	By:	/s/ Christopher Staten
		Christopher Staten
		Interim Chief Financial Officer

EX-99.1

Exhibit 99.1

Aerie Pharmaceuticals Announces Novel Dry Eye Product Candidate AR-15512 (TRPM8 Agonist) Ophthalmic Solution Achieved Statistical Significance Over Multiple Symptoms and Signs in Successful Phase 2b Clinical Study for the Treatment of Dry Eye Disease

AR-15512 (0.003%) BID Advancing to Phase 3; No Treatment-Related Serious or Systemic Adverse Events Reported

Conference Call and Webcast Today, September 15^th, at 5:00 p.m. ET

Durham, N.C., September 15, 2021 — (BUSINESS WIRE) — Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, ocular surface diseases and retinal diseases, today reported positive topline results of its Phase 2b clinical study, named COMET-1, for AR-15512 (TRPM8 Agonist) (“AR-15512”) ophthalmic solution for the treatment of patients with dry eye disease. Management will host a conference call and provide accompanying slides to discuss these results at 5:00 p.m. ET today.

The randomized, double-masked, vehicle-controlled Phase 2b clinical study was conducted at 15 sites throughout the United States and evaluated the efficacy and safety of AR-15512 in patients with dry eye disease. A total of 369 patients were randomized across three arms, AR-15512 (0.0014%), AR-15512 (0.003%) or AR-15512 vehicle, in each case dosed twice daily over 84 days. Patients were evaluated at Days 1, 14, 28 and 84.

AR-15512 Phase 2b Highlights

• The COMET-1 clinical study showed greatest efficacy in the higher concentration 0.003% BID which will be advanced to Phase 3 studies.

• The COMET-1 clinical study achieved statistical significance for multiple pre-specified symptom endpoints:

• Ocular discomfort at Day 84 (p=0.028), SANDE (Symptom Assessment iN Dry Eye) at Days 14, 28 and 84 (p-value between 0.025 and 0.0005) and eye dryness at Day 84 (p=0.03)

• The COMET-1 clinical study achieved statistical significance for multiple pre-specified sign endpoints:

• Efficacy was observed after the first dose

• Tear production at both time points measured (Day 1 and Day 14) based on unanesthetized Schirmer’s score (p<0.0001), conjunctival redness at Day 84 (p=0.022) and ocular surface staining at Day 14 and Day 84 (p=0.012 and p=0.037, respectively)

• The COMET-1 clinical study showed statistically significant improvement in both symptoms and signs as early as Day 14 and continuous improvement through Day 84.

• Both formulations of AR-15512 were safe and well-tolerated. Ninety five percent of adverse events were mild with less than 3 percent of subjects discontinued due to adverse events.

“We are very pleased to have achieved statistically significant improvements on multiple FDA-recognized symptoms and signs in our COMET-1 Phase 2b clinical study. Of particular note, we are excited at the number of symptom endpoints which demonstrated statistical significance given the importance of this for patients suffering from dry eye disease. While we did not achieve statistical significance at our pre-determined primary endpoints at Day 28, as a reminder, this is a Phase 2b study where selecting primary endpoints are not required. Therefore, we believe we have a clear path toward approval,” stated Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie. “We expect to have an end of Phase 2 meeting with the U.S. Food and Drug Administration in the first quarter of 2022. In order to complete development of AR-15512, we expect to conduct two additional three-month Phase 3 efficacy studies and an additional safety study.”

AR-15512, formerly AVX-012, was acquired by Aerie in November 2019 in connection with the acquisition of Avizorex Pharma, S.L., a Spanish ophthalmic pharmaceutical company. AR-15512 has intellectual property protection for pharmaceutical composition and method of use through 2031.

Conference Call / Webcast Information

Aerie management will host a live conference call and webcast at 5:00 p.m. Eastern Time today to discuss the AR-15512 Phase 2b COMET-1 safety and efficacy results.

The live webcast and a replay may be accessed by visiting Aerie’s website at http://investors.aeriepharma.com. In addition, key data slides from the AR-15512 COMET-1 clinical study 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 1-888-734-0328 (U.S.) or 1-678-894-3054 (international) to listen to the live conference call. The conference ID for the live call is 2078767. 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 1-855-859-2056 (U.S.) or 1-404-537-3406 (international). The conference ID number for the replay is 2078767. The telephone replay will be available until September 23, 2021.

About Aerie Pharmaceuticals, Inc.

Aerie is an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, ocular surface diseases and retinal diseases. Aerie’s first product, Rhopressa^® (netarsudil ophthalmic solution) 0.02%, a once-daily eye drop approved by the U.S. Food and Drug Administration (FDA) for

the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, was launched in the United States in April 2018. In clinical trials of Rhopressa^®, the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage. More information about Rhopressa^®, including the product label, is available at www.rhopressa.com. Aerie’s second product for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension, Rocklatan^® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%, the first and only fixed-dose combination of Rhopressa^® and the widely-prescribed PGA (prostaglandin analog) latanoprost, was launched in the United States in May 2019. In clinical trials of Rocklatan^®, the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage. More information about Rocklatan^®, including the product label, is available at www.rocklatan.com. Aerie continues to focus on global expansion and the development of additional product candidates and technologies in ophthalmology, including for the treatment of dry eye disease, wet age-related macular degeneration and diabetic macular edema. More information is available at www.aeriepharma.com.

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 in this release include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the duration and severity of the coronavirus disease (COVID-19) outbreak, including the impact on our clinical and commercial operations, demand for our products and financial results and condition of our global supply chains; our expectations regarding the commercialization and manufacturing of Rhopressa^®, Rocklatan^®, Rhokiinsa^® and Roclanda^® or any product candidates, including AR-15512, or other future product candidates, including the timing, cost or other aspects of their commercial launch; our commercialization, marketing, manufacturing and supply management capabilities and strategies in and outside of the United States; the success, timing and cost of our ongoing and anticipated preclinical studies and clinical trials for Rhopressa^® and Rocklatan^®, with respect to regulatory approval outside of the United States, and any product candidates, including AR-15512, or future product candidates, including statements regarding the timing of initiation and completion of the studies and trials; our expectations regarding the effectiveness of Rhopressa^®, Rocklatan^®, Rhokiinsa^®, Roclanda^® or any product candidates, including AR-15512, or other future product candidates; the timing of and our ability to request, obtain and maintain FDA or other regulatory authority approval of, or other action with respect to, as applicable, Rhopressa^®, Rocklatan^® or any current or future product candidates or preclinical implants; the potential advantages of Rhopressa^® and Rocklatan^® or any product candidates or future product candidates; our plans to pursue development of additional product candidates and technologies; our plans to explore possible uses of our existing proprietary compounds beyond glaucoma, including development of our retina program; our ability to protect our proprietary technology and enforce our intellectual property rights or to develop new

intellectual property; and our expectations regarding strategic operations, including our ability to in-license or acquire additional ophthalmic products, product candidates or technologies. In particular, FDA and European Medicines Agency (EMA) approval of Rhopressa^® and Rocklatan^® do not constitute regulatory approval of Rhopressa^® and Rocklatan^® in other jurisdictions, and there can be no assurance that we will receive regulatory approval for Rhopressa^® and Rocklatan^® in such other jurisdictions, including Japan’s PMDA. In addition, FDA approval of Rhopressa^® and Rocklatan^® do not constitute FDA approval of our product candidates, including AR-15512, or any future product candidates, and there can be no assurance that we will receive FDA approval for our product candidates or any future product candidates. By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics, industry change and other factors beyond our control, and depend on regulatory approvals and economic and other environmental 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 (SEC). 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.

Contact: Ami Bavishi (908) 947-3949; abavishi@aeriepharma.com

Source: Aerie Pharmaceuticals

EX-99.2

A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease Study AR-15512-CS201 (COMET-1) September 2021 Exhibit 99.2

Important Information Any discussion of the potential use or expected success of our product candidates is subject to our regulatory approval. The information in this presentation is current only as of its date and may have changed prior to it being read 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. Forward-looking statements in this presentation includes statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our expectations regarding the effectiveness of our product candidates, including AR-15512, and the success, timing and cost of our ongoing and anticipated clinical trials for our product candidates, including AR-15512. 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. For Investor Use

Dry Eye 1Stonecipher et al. Therapeutics and Clinical Risk Management 2013 Over 30 million individuals in the US alone suffer from dry eye, yet less than 10% are treated. Prevalence of dry eye continues to rise as a result of an aging population, and more frequent use of contact lenses, computers, smartphones, and tablets. Dry eye represents one of the most common reasons for patients seeing an ophthalmologist or optometrist. The majority of patients seeking medical attention for dry eye do not receive a pharmaceutical intervention or punctal plugs.1 Dry eye is a symptomatic disease, yet most products (except Lifitegrast) approved for the chronic treatment of dry eye are not indicated for the improvement of dry eye symptoms. We designed the Phase 2b clinical study to fully characterize a novel TRPM8 agonist in order to optimize the Phase 3 program. For Investor Use Data on file AR-15512 is a development stage product candidate and is not approved by any regulatory agency.

Executive Summary In this Phase 2b clinical study, two concentrations (0.0014% and 0.003%) of AR-15512 dosed twice daily were evaluated for safety and efficacy vs. vehicle in subjects with dry eye. Statistically significant efficacy was demonstrated across multiple pre-specified symptom and sign endpoints with 0.003% AR-15512. Statistically significant improvements in symptoms of Ocular Discomfort, SANDE*, and Eye Dryness. Statistically significant improvements in signs for tear production, conjunctival redness, and ocular surface staining. Efficacy for both symptoms and signs observed as early as 14 days. Continued improvement in symptoms and signs over the 3-month (84-day) study. The formulations were safe and well-tolerated. Most common AE was instillation site burning or stinging (~95% rated as mild). < 2% of subjects in the 0.003% treatment group discontinued the study due to AEs. No systemic or serious AEs attributed to study medication. 0.003% AR-15512 selected for advancement with planned initiation of Phase 3 pivotal studies in H1 2022. For Investor Use Data on file * Symptom Assessment iN Dry Eye AR-15512 is a development stage product candidate and is not approved by any regulatory agency.

TRPM8 (transient receptor potential melastatin) receptors are cold-sensitive thermoreceptors that play key role in tear film homeostasis.1-2 Located on eyelid and cornea. TRPM8 channels detect drops in corneal temperature associated with tear evaporation on ocular surface. AR-15512 is a potent and highly-selective TRPM8 agonist designed as a potential treatment for DED. AR-15512 shown in vivo to increase tearing in a concentration-dependent manner. AR-15512 produces cooling sensation (via TRPM8 receptor) designed to reduce ocular discomfort and pain. Targeting the TRPM8 receptor offers a new modality for treating symptoms and signs dry eye. Neuro-sensory abnormalities now recognized to play a role in the etiology of dry eye disease.3 1Eguchi et al. Biomed Res Int 2017; 2Yang et al. Pharmaceuticals 2018; 3Craig et al. TFOS DEWSII Report. Ocular Surface 2017. Cold-Sensitive Neuron Response to Temperature AR-15512: A Selective TRPM8 Agonist for Dry Eye For Investor Use Data on file AR-15512 is a development stage product candidate and is not approved by any regulatory agency.

Study Design Objective: To evaluate the safety, tolerability, and efficacy of 2 doses (0.0014%, 0.003%) topical ophthalmic AR-15512 compared to vehicle administered twice daily in subjects with dry eye disease (DED). Design: Double-masked, vehicle-controlled multicenter randomized study with environment and controlled adverse environment (CAE) endpoints. Key Endpoints: Symptoms: Ocular Discomfort (ODS), SANDE, Eye Dryness (EDS), Ocular Pain Signs: Schirmer Score (Anesthetized and Unanesthetized), Ocular Surface Staining, Conjunctival Redness, Tear Film Break-up Time Primary (Day 28): Change in ODS; Change in Anesthetized Schirmer For Investor Use Data on file AR-15512 is a development stage product candidate and is not approved by any regulatory agency.

Key Inclusion Criteria Male or female, 30 years of age or older at the Screening visit. Have a history of dry eye disease within the previous 6 months. Have used, and/or desired to use artificial tears for dry eye disease (DED) within 2 months prior to the Screening visit. Symptoms of DED based Ocular Discomfort Score(ODS) – VAS and Global SANDE questionnaires at both the Screening and Baseline visits. Anesthetized Schirmer test score ≥ 2 and  10 mm/5 min at both Screening and Baseline visits. Total corneal fluorescein staining score of ≥ 2 and ≤ 15 based on modified NEI grading scheme (0-20), with no one region scoring >3 at Screening visit. BCVA of 20/200 (0.70 LogMAR) or better in both eyes at both the Screening and Baseline visits. Good general and ocular health, as determined by the investigator using medical history, ophthalmic examination, blood chemistry and hematology, urinalysis and vital signs at the Screening visit. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Able, as assessed by the investigator, and willing to follow study instructions and likely to complete all required study visits. For Investor Use Data on file

Key Exclusion Criteria History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety. History of ocular surgery within 1 year prior to the Screening visit. Punctal or intracanalicular plug present in either eyelid within 1 year prior to the Screening visit or anticipated plug insertion or occlusion at any time during the study. Use of contact lenses in either eye within 7 days prior to Screening visit or planned use during the study. Regular use of lid hygiene within 14 days prior to the Screening visit or any planned use during study. Use of any topical ocular medications for DED, ocular corticosteroid or NSAID, glaucoma medications, eye whitening, topical antibiotics, topical antihistamines, mast cell stabilizers or other OTC or nutritional supplements with exception of ATs within 30 days prior to Screening or anticipated use during study. Use of artificial tears within 2 hours prior to the Screening visit or anticipated use during the study. Use of systemic medications associated with treatment of severe DED and/or Meibomian gland disease (such as oral pilocarpine, oral cevimeline, oral macrolides, oral tetracyclines, oral retinoids within 90 days prior to Baseline Visit or anticipated use during the study. Use of systemic corticosteroids started < 90 days prior to Baseline visit or change in dosage during study. Non-ocular topically applied corticosteroids (including nasal inhalers) will be permitted. Known allergies or sensitivity to the study interventions or study diagnostic agents. Positive pregnancy test at Screening or Baseline, currently breastfeeding or plans to become pregnant during the study. Women of childbearing potential not using a medically acceptable form of birth control. The subject has a condition or is in a situation that, in the investigator’s opinion, may put the subject at significant risk or may confound the study results. For Investor Use Data on file

Subject Disposition 0.0014% AR-15512 n=121 0.003% AR-15512 n=122 Vehicle n=126 Number of Subjects Randomized 121 122 126 Subjects Completed Study, no. (%) 114 (94.2) 115 (94.3) 116 (92.1) Subjects Discontinued, no. (%) Adverse Event Withdrawal of Consent Non-Compliant Lost to Follow-up Investigator Decision Protocol Violation 3 (2.5) 4 (3.3) 0 0 0 0 2 (1.6) 3 (2.5) 1 (0.8) 0 0 1 (0.8) 2 (1.6) 3 (2.4) 1 (0.8) 1 (0.8) 1 (0.8) 2 (1.6) A total of 369 subjects were randomized. The majority of subjects (>94% in active treatment groups) completed the study to Day 84. AEs leading to discontinuation included instillation site burning (2 in 0.0014% and 1 in 0.003%), instillation site stinging (1 in 0.003%) eyelid edema (1 in 0.0014%), epithelial defect (1 in vehicle), and respiratory failure (1 in vehicle). For Investor Use Data on file AR-15512 is a development stage product candidate and is not approved by any regulatory agency.

Baseline Demographics 0.0014% AR-15512 n=121 0.003% AR-15512 n=122 Vehicle n=126 Age (years) 39 (32.2%) 30 (24.6%) 34 (27.0%) Mean (SD) 65.5 (10.89) 62.6 (13.01) 63.1 (11.90) Range 31 – 85 30 - 87 30 - 90 Gender Female, no (%) 82 (67.8%) 92 (75.4%) 92 (73.0%) Race, no (%) White/Caucasian 97 (80.2%) 92 (75.4%) 99 (78.6%) Black/African American 15 (12.4%) 18 (14.8%) 18 (14.3%) Asian 8 (6.6%) 11 (9.0%) 7 (5.6%) Other 1 (0.8%) 1 (0.8%) 2 (1.6%) For Investor Use Data on file AR-15512 is a development stage product candidate and is not approved by any regulatory agency.

Symptoms: Statistically Significant Improvements in Endpoints for 0.003% AR-15512 SYMPTOM TIMING Potential FDA endpoint Ocular Discomfort Score (ODS-VAS) Change from Baseline – Ocular Discomfort VAS Day 84 (p=0.028) Yes Mean Ocular Discomfort VAS Day 84 (p=0.039) Yes SANDE Change from Baseline SANDE Day 14 (p=0.025), Day 28 (p=0.0005), Day 84 (p=0.002) Yes Mean SANDE Day 28 (p=0.017), Day 84 (p=0.008) Yes % Responders SANDE (>20) Day 28 (p=0.0004), Day 84 (p=0.0497) No % Responders SANDE (>30) Day 28 (p=0.0231), Day 84 (p=0.0007) No % Responders SANDE (>40) Day 28 (p=0.0085), Day 84 (p=0.0025) No Eye Dryness (EDS-VAS) Change from Baseline – EDS VAS Day 84 (p=0.03) Yes Mean EDS VAS Day 84 (p=0.075) Yes Change from Baseline - EDS VAS (Post CAE) Day 84 (p=0.009) Yes Ocular Pain (VAS) Change from Baseline – Ocular Pain VAS Day 84 (p=0.079) Yes Ocular Discomfort (Ora Calibra) Mean Ocular Discomfort (Ora Calibra) Day 84 (p=0.035) Yes For Investor Use Data on file AR-15512 is a development stage product candidate and is not approved by any regulatory agency.

Symptoms: Ocular Discomfort (ODS-VAS) p = 0.23 * p = 0.028 (Primary Endpoint) For Investor Use Data on file *=p<0.05 AR-15512 is a development stage product candidate and is not approved by any regulatory agency.

Symptoms: SANDE * p = 0.0015 * p = 0.0005 * p = 0.0254 For Investor Use Data on file *=p<0.05 AR-15512 is a development stage product candidate and is not approved by any regulatory agency.

Symptoms: Eye Dryness (EDS-VAS) * p = 0.03 For Investor Use Data on file *=p<0.05 AR-15512 is a development stage product candidate and is not approved by any regulatory agency.

Symptoms: Ocular Pain (VAS) p = 0.079 For Investor Use Data on file AR-15512 is a development stage product candidate and is not approved by any regulatory agency.

Signs: Statistically Significant Improvements in Endpoints for 0.003% AR-15512 SIGN TIMING Potential FDA endpoint Schirmer Score (Unanesthetized) * Change from Baseline – Schirmer Day 1 (p<0.0001), Day 14 (p<0.0001) Yes % Responders (>10 mm) Day 1 (p<0.0001), Day 14 (p<0.0001) Yes** Conjunctival Redness Change from Baseline Conjunctival Redness Day 84 (p=0.022) Yes Ocular Surface Staining Change from Baseline Total Surface Staining Day 14 (p=0.012), Day 84 (p=0.037) Yes Change from Baseline Conjunctival Staining Day 14 (p=0.005) Yes Mean Conjunctival Staining Day 14 (p=0.054) Yes * Unanesthetized Schirmer Score only measured at baseline and Day 14 ** Schirmer Responders (>10 mm) potentially a stand-alone endpoint for dry eye approval For Investor Use Data on file AR-15512 is a development stage product candidate and is not approved by any regulatory agency.

Signs: Change from Baseline Anesthetized Schirmer p = 0.494 (Primary Endpoint) For Investor Use Data on file AR-15512 is a development stage product candidate and is not approved by any regulatory agency.

Signs: Change from Baseline Unanesthetized Schirmer * p < 0.0001 * p < 0.0001 * p < 0.0001 * p < 0.0001 For Investor Use Data on file *=p<0.05 AR-15512 is a development stage product candidate and is not approved by any regulatory agency.

Signs: Unanesthetized Schirmer Responders >10 mm * p < 0.0001 * p < 0.0001 * p < 0.0001 * p < 0.0001 For Investor Use Data on file *=p<0.05 AR-15512 is a development stage product candidate and is not approved by any regulatory agency.

Signs: Conjunctival Redness * p < 0.022 For Investor Use Data on file *=p<0.05 AR-15512 is a development stage product candidate and is not approved by any regulatory agency.

Signs: Total Ocular Surface Staining * p < 0.012 * p < 0.003 * p < 0.037 For Investor Use Data on file *=p<0.05 AR-15512 is a development stage product candidate and is not approved by any regulatory agency.

Overall Safety 0.0014% AR-15512 n=121 0.003% AR-15512 n=122 Vehicle n=126 Any Treatment-Emergent AE 57 (47.1%) 63 (51.6) 26 (20.6%) Serious TEAEs 1 (0.8%) 1 (0.8%) 2 (1.6%) Serious TEAEs Related to Study Medication 0 0 0 TEAEs by severity Mild Moderate Severe 50 (41.3%) 5 (4.1%) 2 (1.7%) 59 (48.4%) 3 (2.5%) 1 (0.8%) 18 (14.3%) 7 (5.6%) 1 (0.8%) TEAEs Leading to Discontinuation 3 (2.5%) 2 (1.6%) 4 (3.2%) Overall, the study medications were well-tolerated. No serious TEAEs were considered related to study medication. Few TEAEs leading to study discontinuation. Most TEAEs were ocular. For Investor Use Data on file AR-15512 is a development stage product candidate and is not approved by any regulatory agency.

Ocular Treatment-Emergent Adverse Events 0.0014% AR-15512 n=121 0.003% AR-15512 n=122 Vehicle n=126 Any Ocular Treatment-Emergent AE 51 (42.1%) 59 (48.4%) 13 (10.3%) Ocular TEAE by Severity Mild Moderate Severe 49 (40.5%) 1 (0.8%) 1 (0.8%) 56 (45.9%) 2 (1.6%) 1 (0.8%) 12 (9.5%) 1 (0.8%) 0 Ocular TEAEs Leading to Discontinuation 3 (2.5%) 2 (1.6%) 1 (0.8%) The vast majority of ocular TEAEs (> 95% in active groups) were rated as mild by the subject. Only 5 Ocular TEAEs (3 in 0.0014% and 2 in 0.003% groups) led to study discontinuation. For Investor Use Data on file AR-15512 is a development stage product candidate and is not approved by any regulatory agency.

0.0014% AR-15512 n=121 0.003% AR-15512 n=122 Vehicle n=126 Any Ocular Treatment-Emergent AE 51 (42.1%) 59 (48.4%) 13 (10.3%) Eye Disorder 12 (9.9) 6 (4.9) 9 (7.1) Chalazion 0 0 1 (0.8) Conjunctival hemorrhage 0 0 1 (0.8) Conjunctival hyperemia 1 (0.8) 0 0 Conjunctival edema 1 (0.8) 0 0 Corneal epithelium defect 0 0 1 (0.8) Corneal infiltrate 1 (0.8) 0 0 Eye irritation 1 (0.8) 0 0 Eye pain 1 (0.8) 0 0 Eye pruritis 1 (0.8) 0 0 Eyelid margin crusting 0 0 1 (0.8) Eyelid edema 1 (0.8) 0 0 Lacrimation increased 2 (1.7) 0 0 Photophobia 1 (0.8) 0 0 Posterior capsular opacification 0 0 1 (0.8) Retinal tear 1 (0.8) 0 0 Swelling of eyelid 0 2 (1.6) 0 Vision blurred 0 1 (0.8) 1 (0.8) Visual acuity reduced 2 (1.7) 2 (1.6) 2 (1.6) Visual impairment 0 1 (0.8) 0 Vitreous Detachment 2 (1.7) 0 1 (0.8) General Disorder and Administration site 45 (37.2) 53 (43.4) 4 (3.2) Instillation site irritation 1 (0.8) 0 0 Instillation site burning or stinging 45 (37.2) 53 (43.4) 4 (3.2) Instillation site pruritis 1 (0.8) 1 (0.8) 0 Infections Conjunctivitis 0 0 1 (0.8) Injury Corneal Abrasion 0 1 (0.8) 0 Investigations Vital Dye Staining 0 1 (0.8) 0 Nervous System Disorders Migraine with aura 0 1 (0.8) 0 Skin manifestations Echymosis 1 (0.8) 0 0 Ocular Treatment-Emergent Adverse Events For Investor Use Data on file AR-15512 is a development stage product candidate and is not approved by any regulatory agency.

Burning or Stinging Upon IP Instillation Overall, 3 subjects discontinued the study early due to instillation site burning (2 in 0.0014% and 1 in 0.003%) and 1 subject discontinued due to instillation site stinging (0.003%) For Investor Use Data on file AR-15512 is a development stage product candidate and is not approved by any regulatory agency.

Non-Ocular Treatment-Emergent Adverse Events 0.0014% AR-15512 n=121 0.003% AR-15512 n=122 Vehicle n=126 Any Ocular Treatment-Emergent AE 18 (14.9%) 9 (7.4%) 16 (12.7%) Non-Ocular TEAE by severity Mild Moderate Severe 13 (10.7%) 4 (3.3%) 1 (0.8%) 8 (6.6%) 1 (0.8%) 0 9 (7.1%) 6 (4.8%) 1 (0.8) Non-Ocular TAEs leading to discontinuation 0 0 3 (2.4%) Similar percentage of non-ocular treatment-emergent AEs across all groups without any notable findings. None of the systemic AEs were considered to be likely related or related to study medication. For Investor Use Data on file AR-15512 is a development stage product candidate and is not approved by any regulatory agency.

Summary In this Phase 2b clinical study, 369 dry eye subjects were randomized to one of 3 treatment groups (0.0014% AR-15512, 0.003% AR-15512 or vehicle). Statistically significant efficacy was demonstrated across multiple pre-specified symptom and sign endpoints with 0.003% AR-15512. Symptoms: Ocular Discomfort, SANDE, Eye Dryness. Signs: Tear production, conjunctival redness, ocular surface staining. Early onset (within 14 days) of efficacy as well as continued improvement in symptoms and signs demonstrated over 3-months. The formulations were safe and well-tolerated. Vast majority (~95%) of all ocular AEs rated as mild and < 2% of subjects in the 0.003% treatment group discontinued due to AEs. No systemic or serious AEs attributed to study medication. 0.003% AR-15512 selected for advancement to Phase 3 development. For Investor Use Data on file AR-15512 is a development stage product candidate and is not approved by any regulatory agency.

Next Steps: End-of-Phase 2 meeting with FDA in Q1 2022 with Phase 3 initiation in Q2 2022. Plan two 3-month efficacy studies and safety study. Expected NDA submission H1 2024. For Investor Use Data on file AR-15512 is a development stage product candidate and is not approved by any regulatory agency.

Background on Presenters David Hollander, MD, MBA Chief R&D Officer Cornea-trained ophthalmologist Former leadership roles at Allergan (Global VP and Therapeutic Area Head) and Ora, Inc. (Chief Medical Officer) Michelle Senchyna, PhD Vice President, Clinical Development and Medical Affairs Worked on over 20 dry eye studies Former leadership roles at Allergan (Executive Director of Ophthalmology) and Alcon (R&D and Medical Affairs) For Investor Use

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Document and Entity Information	Sep. 15, 2021
Cover [Abstract]
Entity Registrant Name	AERIE PHARMACEUTICALS INC
Amendment Flag	false
Entity Central Index Key	0001337553
Document Type	8-K
Document Period End Date	Sep. 15, 2021
Entity Incorporation State Country Code	DE
Entity File Number	001-36152
Entity Tax Identification Number	20-3109565
Entity Address, Address Line One	4301 Emperor Boulevard
Entity Address, Address Line Two	Suite 400
Entity Address, City or Town	Durham
Entity Address, State or Province	NC
Entity Address, Postal Zip Code	27703
City Area Code	(919)
Local Phone Number	237-5300
Written Communications	false
Soliciting Material	false
Pre Commencement Tender Offer	false
Pre Commencement Issuer Tender Offer	false
Security 12b Title	Common Stock, par value $0.001 per share
Trading Symbol	AERI
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false