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 8, 2018
`
`Aerie Pharmaceuticals, Inc.
`
`(Exact name of registrant as specified in its charter)
`
`Delaware
`(State or other jurisdiction
`of incorporation)
`
`001-36152
`(Commission
`File Number)
`
`20-3109565
`(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))
`☐
`
`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. ☐
`
`Micro Labs Exhibit 1056
`Micro Labs v. Santen Pharm. and Asahi Glass
`IPR2017-01434
`
`

`

`Regulation FD Disclosure.
`Item 7.01.
`On or after January 8, 2018, 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.
`(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 2018.
`
`Financial Statements and Exhibits.
`
`Micro Labs Exhibit 1056-2
`
`

`

`
`Exhibit
`99.1
`
`Description
`Company Overview Presentation dated January 2018.
`
`EXHIBIT INDEX
`
`Micro Labs Exhibit 1056-3
`
`

`

`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 8, 2018
`
`
`
`
`
` By: /s/ Richard J. Rubino
`
` Richard J. Rubino
`
` Chief Financial Officer
`
`Micro Labs Exhibit 1056-4
`
`

`

`Exhibit 99.1
`
`Company Overview
`Investor Presentation
`January 2018
`
`Micro Labs Exhibit 1056-5
`
`

`

`Important Information
`
`The information in this presentation does not contain all of the information that a potential investor should review before investing in Aerie shares.
`The descriptions of Aerie Pharmaceuticals, Inc. (the “Company” or “Aerie”) in this presentation are qualified in their entirety by reference to reports
`filed with the SEC. Certain information in this presentation has been obtained from outside sources. While such information is believed to be reliable
`for the purposes used herein, no representations are made as to the accuracy or completeness thereof and we take no responsibility for such
`information.
`
`Any discussion of the potential use or expected success of Rhopressa ® (netarsudil ophthalmic solution) 0.02%, with respect to foreign approval or
`additional indications, and our current or any future product candidates is subject to regulatory approval. In addition, any discussion of U.S. Food
`and Drug Administration (“FDA”) approval of Rhopressa ® does not guarantee successful commercialization of Rhopressa ® or FDA approval of
`Roclatan TM. For more information on Rhopressa ®, refer to the full Rhopressa ®product label at http://investors.aeriepharma.com.
`
`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 any guidance or timelines 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. In particular, FDA approval of Rhopressa ®does not constitute
`approval of Roclatan TM, and there can be no assurance that we will receive FDA approval for Roclatan TM or any future product candidates. Any top
`line data presented herein is preliminary and based solely on information available to us as of the date of this presentation 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.
`
`For Investor Use
`
`2
`
`Micro Labs Exhibit 1056-6
`
`

`

`Aerie:
`Building a Major Ophthalmic Pharmaceutical Company
`
`Aerie IOP–Lowering Products (IP 2030+)
`
`• Rhopressa® (netarsudil ophthalmic solution) 0.02%
`• Aerie-owned new chemical entity
`• FDA ApprovedDecember18, 2017;in launchmode
`• Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%
`• Two P3’s achieved primary efficacy endpoints
`• NDA submissionexpected2Q 2018
`
`Pipeline Activities
`
`• Rhopressa®
`• 24-hour IOP lowering, normal tension glaucoma, disease modification, etc.
`• AR-13503(ROCK/PKC inhibitor)and AR-1105(dexamethasonesteroid)
`• Pre-clinical molecules for diseases of the retina
`• Drug Delivery– Focusedon backof the eye (e.g.,PRINT® / DSM)
`
`Data on file
`
`For Investor Use
`
`3
`
`Micro Labs Exhibit 1056-7
`
`

`

`®: Market Perspective
`Rhopressa
`
`2016 U.S. Glaucoma Market
`
`- ~$3B Market, 36M TRx, 60M bottles
`- Half of volume first-line (PGAs)
`- Half of volume 2-4X/Day Adjuncts
`
`(9%)
`
`(8%)
`
`(36%)
`
`(8%)
`
`(10%)
`
`(16%)
`
`(13%)
`
`Rhopressa®: Positioning as an Adjunctive Therapy
`
`- Once-daily dosing directed at site of pathology, the trabecular meshwork
`- Consistent IOP lowering over 12 months and across all IOPs tested, as
`demonstrated in clinical trials
`
`®
`Refer to the full Rhopressa product label at
`http://investors.aeriepharma.com
`
`Graph Source: IMS Data
`CAI: Carbonic Anhydrase Inhibitor
`AA: Alpha Agonist
`BB: Beta Blocker
`
`For Investor Use
`
`44
`
`Micro Labs Exhibit 1056-8
`
`

`

`®: Commercialization
`Rhopressa
`
`Hired Chief Commercial Officer and VPs of Sales, Marketing,
`Market Access, Commercial Operations, and Medical Affairs in
`2016/2017, and Chief Compliance Officer in 2015
`Preparing to hire U.S. salesforce of 100 reps; expected to be fully
`trained during 2Q 2018
`Sales territories finalized and hiring of Sales Regional Directors
`and District Managers proceeding
`Market access meetings with top Medicare Part D and Commercial
`Payors under way
`- Covered market is ~50/50 Commercial / Part D
`- Part D coverage expected to commence January 2019
`We believe awareness of Rhopressa® is high among
`ophthalmologists
`
`Fully Prepared to Execute Launch Plan
`
`For Investor Use
`
`55
`
`Micro Labs Exhibit 1056-9
`
`

`

`Rhopressa®: Launch Plan
`
`Marketing
`
`Broad Strategy
`Brand Planning and Messaging
`KOL Engagement
`Field Support
`
`Sales
`
`Hire Reps
`Sales Training and Deployment
`Target 12K Prescribers / 80% of Volume
`Success Metrics and Standards
`
`Market Access
`
`Commercial Operations
`
`Payer Engagement
`Field Deployment
`Commercial and Med D Strategy
`Drive to Preferred Formulary Positioning
`
`Supply Chain Management
`Sales Execution Readiness
`Analytics/Reporting
`Field Support Programs
`
`For Investor Use
`
`6
`
`Micro Labs Exhibit 1056-10
`
`

`

`U.S. Launch Plan Timeline
`
`December 2017: Rhopressa ®
`FDA Approval
`1Q-2018: Begin
`Hiring 100
`Sales Reps
`2Q-2018: Rhopressa ®
`Commercial Launch
`2Q/3Q-2018: Rhopressa ®
`Sampling and
`Initial Commercial Sales
`
`2018
`
`Over 1,500
`Experienced
`Applicants
`To Date
`
`1H-2019: Potential
`Roclatan TM Launch
`
`2019
`
`2Q/3Q-2018:
`Rhopressa ®
`Commercial Coverage
`Majority Non-Preferred
`End of 2018: Rhopressa ®
`Commercial Coverage
`Majority Preferred
`
`1H-2019: Roclatan™
`Commercial Coverage
`Commences
`
`January 2019: Rhopressa ®
`Med D Coverage
`Majority Preferred
`
`January 2020:
`Roclatan™
`Med D Coverage
`Commences
`
`All dates, except for FDA approval for Rhopressa ®, are estimates. Roclatan TM has not been approved by the FDA.
`The NDA for Roclatan TM is expected to be submitted in 2Q 2018
`
`For Investor Use
`
`7
`
`SALES
`
`ACCESS
`
`Micro Labs Exhibit 1056-11
`
`

`

`Medical Affairs
`Building a World Class Medical Affairs Team
`
`• Hired highly-experienced, successful and recognized leaders in Medical
`Affairs, Medical Science, Field Medical Affairs and Professional Affairs
`
`• Communicating the key medical scientific messages
`
`• Responding to technical questions from practitioners and managed care
`decision makers
`
`• Placing speakers at national, regional and local scientific meetings
`
`• Active presence at major ophthalmic conferences, including a Medical
`Affairs Booth
`
`For Investor Use
`
`8
`
`Micro Labs Exhibit 1056-12
`
`

`

`Building Aerie’s Presence in the Medical Community:
`19 Podium Presentations at Major Eyecare Meetings
`
`American Glaucoma Society (AGS)
`March 2017
`
`American Society of Cataract Refractive
`Surgeons (ASCRS) May 2017
`
`3 Presentations, including 3-Month
`Interim Results of Mercury 1, Asrani et
`al., and Aqueous Humor Dynamics of
`Netarsudil Ophthalmic Solution 0.02% in
`Healthy Volunteers, Sit et al.
`
`Aerie Medical
`Affairs Booth
`highlighted, in
`addition to
`presentation
`
`Association of Research in Vision and
`Ophthalmology (ARVO) May 2017
`
`World Glaucoma Congress
`Helsinki June 2017
`
`4 Presentations, including 24-Hour IOP
`Lowering of Netarsudil, Peace et al.
`5 Posters, including Enhancing Efficacy
`by Continuous Delivery of AR-13154 in
`an Animal Model of Proliferative Diabetic
`Retinopathy, Carbajal et al.
`
`For Investor Use
`
`9
`
`Micro Labs Exhibit 1056-13
`
`

`

`RoclatanTM Combination Product Candidate
`
`RoclatanTM
`
`(netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%
`
`Positioning as First Line Therapy:
`
`• Benefits of Rhopressa®while also targeting the secondarydrain
`• Achieved statistical superiority to market-leading latanoprost in two
`P3 trials
`• Potential to become the most efficacious IOP-lowering medication
`for glaucoma or ocular hypertension, if approved
`
`NDA Submission Expected 2Q 2018
`
`Data on file
`
`Roclatan TM has not been approved by the FDA
`
`For Investor Use
`
`10
`
`Micro Labs Exhibit 1056-14
`
`

`

`RoclatanTM Efficacy and Safety
`Efficacy:
`• RoclatanTM demonstratedstatisticalsuperiorityover its components(market-
`leading PGA latanoprost and Rhopressa®) in Mercury 1 and 2 Phase 3 trials, at
`all measured time points
`
`• Consistent incremental IOP-lowering over latanoprost and Rhopressa® in the
`range of 1 to 3 mmHg
`
`Safety:
`• No treatment-related serious adverse events and minimal evidence of
`treatment-related systemic effects. The most common adverse event is
`conjunctival hyperemia with ~60% incidence, majority mild and sporadic and
`present in 20% of subjects at baseline
`• Other ocularAEs occurringin ~5-15% of subjectsreceivingRoclatanTM
`included: cornea verticillata, conjunctival hemorrhage, eye pruritus, lacrimation
`increased, visual acuity reduced, blepharitis and punctate keratitis
`
`Data on file
`
`For Investor Use
`
`11
`
`Micro Labs Exhibit 1056-15
`
`

`

`RoclatanTM Phase 3 Month 12 Responder Analysis:
`Goal is to Achieve Lowest IOP Possible
`
`At Month 12: % of Patients with IOP Reduced to 18 mmHg or Lower
`
`100%
`
`80%
`
`60%
`
`40%
`
`20%
`
`0%
`
`82%
`
`72%
`
`66%
`
`57%
`
`60%
`
`43%
`
`37%
`
`35%
`
`49%
`
`49%
`
`27%
`
`16%
`
`12%
`
`26%
`
`22%
`
`14 mmHg
`
`15 mmHg
`
`16 mmHg
`
`17 mmHg
`
`18 mmHg
`
`®
`Rhopressa (n=148)
`*p<0.05, **p<0.01, ***p<0.0001
`++Data on File
`Based on Mercury 1 Interim Analysis 2
`
`IOP on Treatment
`Latanoprost (n=203)
`
`™
`Roclatan (n=158)
`
`For Investor Use
`
`12
`
`Micro Labs Exhibit 1056-16
`
`

`

`Roclatan™ Next Steps
`
`• RoclatanTM NDA submission expected 2Q 2018
`
`• Aerie Ireland plant and 2 contract manufacturers are
`expected to support RoclatanTM U.S. commercial activities
`
`• Mercury 3 commenced in Europe 3Q 2017
`- Trial conducted in U.K., France, Germany, Italy, Spain, Belgium and
`Austria
`
`- Marketing Authorization Application (MAA) in Europe expected in
`2H 2019
`
`For Investor Use
`
`13
`
`Micro Labs Exhibit 1056-17
`
`

`

`Expanding Aerie Franchise: Europe and Japan
`• Europe (2016 Europe “Big 5” Glaucoma Market: 90M units per year, 1.5X
`U.S. units)
`• Expect to file MAA for Rhopressa® in 2H 2018
`
`• Current clinical plan expected to satisfy European regulatory requirements
`TM
`(including Rocket 4 for Rhopressa® and Mercury 3 for Roclatan )
`
`• Mercury 3: 6-month safety and 90-day efficacy registration trial for Europe,
`comparing Roclatan for non-inferiority to a fixed-dose combo in Europe
`TM
`(Ganfort®) started 3Q 2017. Approximately 250 patients per arm.
`
`• Construction of Ireland Plant in process to support worldwide commercial
`supply
`• Japan (2016 Glaucoma Market: 52M units per year)
`• Plan to advance clinical development on our own
`
`• Phases 1 and 2 under way in the U.S. on Japanese and Japanese-
`Americans, initiated 4Q 2017
`
`• Phase 3 trials expected to be conducted in Japan
`
`For Investor Use
`
`14
`
`Micro Labs Exhibit 1056-18
`
`

`

`Europe Glaucoma Market:
`Aerie Expects to Commercialize on Its Own (if approved)
`
`“Big 5” Europe Glaucoma Market – 2016
`$1.0B; 90M TRx*
`
`Non-PGA Market (47%)
`
`PGA Market (53%)
`
`2 - 4 Times Daily
`
`AA
`
`Non-PGA
`Fixed Combo
`
`CAI
`
`4%
`
`17%
`
`BB
`
`12%
`
`Others
`
`Bimatoprost
`
`3%
`
`10%
`
`Travoprost
`
`Once Daily
`
`6%
`
`19%
`
`Latanoprost
`
`12%
`
`17%
`
`Tafluprost
`2%
`
`PGA Fixed
`Combo
`
`PGA: Prostaglandin Analogue; BB: Beta Blocker; AA: Alpha Agonist; CAI: Carbonic Anhydrase Inhibitor
`Sources: IMS Analytics Link at ex-manufacturer price level.
`*TRx calculated from IMS unit data (1 month = 1 TRx)
`
`For Investor Use
`
`15
`
`Micro Labs Exhibit 1056-19
`
`

`

`Japan Glaucoma Market:
`Aerie Expects to Partner for Commercialization (if approved)
`
`Japan Glaucoma Market – 2016
`$0.8B; 52M Units Annually
`
`Non-PGA Market (48%)
`
`PGA Market (52%)
`
`2 - 4 Times Daily
`
`ROCK
`Inhibitors Others
`4% 3%
`
`Unoprostone
`Bimatoprost
`6%
`Travoprost
`
`CAI
`
`9%
`
`6%
`
`Once Daily
`(Unoprostone is bid)
`
`AA
`
`12%
`
`20%
`
`Latanoprost
`
`Non-PGA
`Fixed Combo
`
`12%
`
`BB
`
`10%
`
`9%
`
`9%
`
`Tafluprost
`
`PGA Fixed
`Combo
`
`PGA: Prostaglandin Analogue; BB: Beta Blocker; AA: Alpha Agonist; CAI: Carbonic Anhydrase Inhibitor
`Sources: IMS Analytics Link at ex-manufacturer price level. *Monthly Units calculated from IMS SU Data
`
`For Investor Use
`
`16
`
`Micro Labs Exhibit 1056-20
`
`

`

`Advancing the Pipeline
`
`• Rhopressa ®
`• Potential for disease modification in glaucoma
`• 24-hour IOP lowering
`
`• Retina Program Opportunities:
`AR-13503* (ROCK/PKC inhibitor) potentially for AMD and DME
`AR-1105 (dexamethasone steroid) potentially for DME
`
`• Drug Delivery
`• Focusedon implantsfor retinaldiseases(DSM / PRINT ®)
`
`* Active metabolite of AR-13154
`
`AR-13503 and AR-1105 are preclinical stage molecules and have not been approved by the FDA
`
`For Investor Use
`
`17
`
`Micro Labs Exhibit 1056-21
`
`

`

`Netarsudil* Causes Expansion of TM Tissue,
`Opening Spaces for Increased Outflow
`
`Control
`
`+ Netarsudil
`
`200um
`
`
`Increasing Trabecular Outflow, Reducing Fibrosis Could StopIncreasing Trabecular Outflow, Reducing Fibrosis Could Stop
`
`Degeneration of Outflow Tissues in GlaucomaDegeneration of Outflow Tissues in Glaucoma
`*Active ingredient of Rhopressa ®
`Source: Ren R et al. Invest Ophthalmol Vis Sci. 2016; 57(14):6197-6209.
`
`For Investor
`Use
`
`18
`
`TM: Trabecular Meshwork
`SC: Schlemm’s Canal
`Control = buffered saline solution
`
`Micro Labs Exhibit 1056-22
`
`

`

`Rhopressa® 24-hour IOP Pilot Study
`Demonstrates Effective Nocturnal Efficacy
`
`**
`
`**
`
`***
`
`***
`
`**
`
`**
`
`***
`
`**
`
`Baseline
`(n=8)
`
`Netarsudil
`(n=8)
`
`Pre-dose
`
`Post-dose (Day 8/9)
`
`** 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 reducedefficacy at night (PGAs, CAIs) 1 - 6
`
`For
`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-
`Investor
`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.
`Use
`
`19
`
`Micro Labs Exhibit 1056-23
`
`

`

`Retinal Diseases – Aerie’s Next Chapter
`
`The market for retina eye diseases is twice that of glaucoma with $4.9
`billion in the U.S. and $9 billion worldwide per IMS
`
`Current treatments for retina eye diseases lose efficacy over time, some
`have very serious side effects and there are limited surgical options
`
`The majority of current treatments for retina eye diseases require repeated
`injections into the patient’s eye
`Aerie has two preclinical molecules for the treatment of retinal disease:
`
`- AR-13503 (ROCK/PKC Inhibitor) for AMD/DME
`- AR-1105 (dexamethasone steroid) for DME
`
`Aerie also has access to bio-erodible implant technology through DSM
`collaboration, and also has ophthalmic rights to PRINT ® technology, a fully
`scalable manufacturing platform for implants
`
`For Investor Use
`
`2020
`
`Micro Labs Exhibit 1056-24
`
`

`

`2016 U.S. Retina Market
`
`2016 Sales: $4.9B
`
`steroids,
`$0.1
`
`others,
`$0.03
`
`U.S. Unit Sales: 6.5M
`
`steroids,
`0.2
`
`others,
`0.1
`
`Lucentis,
`$1.4
`
`Avastin,
`$0.02
`
`Eylea,
`$3.3
`
`Eylea, 2.3
`
`Lucentis,
`0.9
`
`Avastin,
`3.0
`
`Source: IMS Data
`
`For Investor Use
`
`2121
`
`Micro Labs Exhibit 1056-25
`
`

`

`AR-13503: A First-in-Class ROCK/PKC Inhibitor for the
`Treatment of Wet AMD and Diabetic Retinopathy
`
`• Active metabolite of AR-13154 and netarsudil
`• Potential to improve outcomes by targeting multiple
`disease processes
`• Monotherapy shows strong efficacy in preclinical models
`• Effective as adjunct to anti-VEGF therapy in preclinical
`models
`• Expect durable treatment effect with injection frequency
`of once every 4 –6 months
`
`For Investor Use
`
`22
`
`Micro Labs Exhibit 1056-26
`
`

`

`Aerie Preclinical Molecule Provides Additive Efficacy to
`Eylea® in a Proliferative Diabetic Retinopathy Model
`Oxygen-induced retinopathy model of PDR (mouse)
`AR-13154(S) is a precursor molecule to AR-13503
`Confirms potential as monotherapy and as adjunct to anti-VEGF
`therapies; not yet tested in humans
`
`120%
`
`100%
`
`80%
`
`60%
`
`40%
`
`20%
`0%
`
`Total Neovascular Area
`
`***
`
`-37%
`
`***
`-34%
`
`***
`**
`-57%
`
`Vehicle Control
`(n=55)
`
`AR-13154(S)
`topical
`(n=28)
`
`Eylea
`1mg/kg IP (n=26)
`
`AR-13154(S) +
`Eylea (n=18)
`
`Data on file; Carbajal, KS et al., Enhancing Efficacy by Continuous Delivery of AR-13154(S)
`in an Animal Model of Proliferative Diabetic Retinopathy, ARVO 2017, Poster B0481.
`
`For more information on Eylea®
`please see the product webpage
`https://www.eylea.us/
`
`For Investor Use
`
`23
`
`Micro Labs Exhibit 1056-27
`
`

`

`DSM Collaboration – Implant Delivery Technology
`•
`Intravitreal sustained-release, bio-erodible implant technology
`• Potential for treatment of Wet AMD and Diabetic Retinopathy
`
`• Promising results from ongoing feasibility study
`• Evaluating AR-13503 (ROCK/PKC inhibitor) and related Aerie compounds
`• Linear sustained elution rates over several months
`• Achieved target retinal drug concentrations
`
`• Executed collaboration/licensing agreement
`• Continue prototype evaluations and IND-enabling activities
`
`Data on File
`
`For Investor Use
`
`24
`
`Micro Labs Exhibit 1056-28
`
`

`

`PRINT® Technology for Ophthalmology
`
`Micropatterned
`Template
`
`Mold formation
`
`Mold Filling
`(e.g. drug/polymer)
`
`Particle Array
`
`PRINT= Particle Replication In Non-wetting Templates
`Aerie recently acquired the rights to use this technology for ophthalmic
`applications
`Proprietary technology capable of creating precisely engineered sustained-release
`products using fully scalable manufacturing processes
`Expected to accelerate development of Aerie’s retinal disease program, including
`pre-clinical AR-13503 and AR-1105
`
`Best in class control over particle size, shape and formulation
`
`For Investor Use
`
`25
`
`Micro Labs Exhibit 1056-29
`
`

`

`Evaluating Aerie’s 3,000+ Owned Molecules
`
`• Commencing screening for
`additional indications beyond
`ophthalmology
`• ROCK inhibition has
`potential in:
`• Pulmonary health,
`including pulmonary
`fibrosis and bronchial
`asthma
`• Dermatology indications
`• Cancer
`• Others
`
`ROCK
`
`Aerie molecules inhibit
`both ROCK1
`and ROCK2
`
`Relationship tree of human kinases. TK, TKL, STE, CK1, AGC, CAMK, CMGC, Other: Kinase superfamilies
`
`For Investor Use
`
`26
`
`Micro Labs Exhibit 1056-30
`
`

`

`Summary
`• Lead Product Priorities
`• Rhopressa®: Successful launch execution expected in 2Q 2018
`
`• Roclatan™:
`
`Mercury 3 commenced 3Q 2017 (EU)
`U.S. NDA submission expected in 2Q 2018
`• Research Initiatives
`• Rhopressa® 24-hour IOP lowering, normal tension glaucoma, disease modification
`AR-13503 (ROCK/PKC inhibitor) and AR-1105 (dexamethasone steroid)
`•
`with potential for retinal diseases
`Evaluating Aerie’s 3,000+ proprietary Rho kinase molecules – beyond ophthalmology
`•
`• Business Development and Expansion Opportunities
`• Drug delivery opportunities focused on back of the eye (e.g., PRINT ® / DSM)
`EU/JP clinical path and commercialization strategy
`•
`Ireland Manufacturing Facility
`
`•
`
`For Investor Use
`
`27
`
`Micro Labs Exhibit 1056-31
`
`

`

`Key Product-Related Milestones
`
`Q1-2017: Rhopressa ®
`NDA Resubmitted
`
`Q2-2017: Rhopressa ®
`Rocket 4 Topline safety (6 mos)
`
`December 2017: Rhopressa ®
`FDA Approval
`
`2Q-2018: Rhopressa ®
`U.S. Launch Expected
`
`2H-2018: Rhopressa®
`Potential EU MAA Filing
`
`2017
`
`2018
`
`Q2-2017: Roclatan™
`P3 Mercury 2
`Topline Efficacy (3 mos)
`
`2Q-2018: Roclatan™
`NDA Submission Expected
`
`Q3-2017: Roclatan™
`P3 Mercury 1
`12-month Safety
`
`Q3-2017: Roclatan™
`P3 Mercury 3 (EU)
`Initiation (6 mos)
`
`1H-2019: Roclatan™
`Potential U.S. Approval and Launch
`
`2018 and 2019 dates are estimates. Roclatan
`
`TM has not been approved by the FDA.
`
`For Investor Use
`
`28
`
`Micro Labs Exhibit 1056-32
`
`