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 12, 2017
`
`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 1057
`Micro Labs v. Santen Pharm. and Asahi Glass
`IPR2017-01434
`
`

`

`Item 7.01. Regulation FD Disclosure.
`On or after September 12, 2017, representatives of Aerie Pharmaceuticals, Inc. (the “Company”) may present to various investors the information described in
`the slides attached to this report as Exhibit 99.1 hereto, which is hereby incorporated by reference into this Item 7.01.
`
`The information in this Item 7.01 (including Exhibit 99.1) is being furnished, not filed, pursuant to Regulation FD. Accordingly, the information in this Item
`7.01 will not be incorporated by reference into any registration statement filed by the Company under the Securities Act of 1933, as amended, unless
`specifically identified therein as being incorporated therein by reference. The furnishing of the information in this Item 7.01 is not intended to, and does not,
`constitute a determination or admission by the Company that this information is material or complete, or that investors should consider this information
`before making an investment decision with respect to any security of the Company.
`
`Item 9.01. Financial Statements and Exhibits.
`(d) Exhibits.
`The following exhibit relating to Item 7.01 shall be deemed to be furnished, and not filed:
`
`99.1
`
` Company Overview Presentation dated September 2017.
`
`Micro Labs Exhibit 1057-2
`
`

`

`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 12, 2017
`
`
`
`
`
` By: /s/ Richard J. Rubino
`
` Richard J. Rubino
`
` Chief Financial Officer
`
`Micro Labs Exhibit 1057-3
`
`

`

`
`Exhibit
`99.1
`
`Description
`Company Overview Presentation dated September 2017.
`
`EXHIBIT INDEX
`
`Micro Labs Exhibit 1057-4
`
`

`

`Exhibit 99.1
`
`Company Overview
`Investor Presentation
`September 2017
`
`Micro Labs Exhibit 1057-5
`
`

`

`Important Information
`
`Any discussion of the potential use or expected success of our product candidates is subject to our product candidates
`being approved by regulatory authorities. In addition, any discussion of clinical trial results for RhopressaTM (netarsudil
`ophthalmic solution) 0.02% relate to the results in its first Phase 3 registration trials named Rocket 1 and Rocket 2, or
`Rocket 4 which will be used primarily for European regulatory filing purposes, and for RoclatanTM (netarsudil/latanoprost
`ophthalmic solution) 0.02%/0.005% relate to the results in its Phase 3 registration trials.
`
`The information in this presentation is current only as of its date and may have changed or may change in the future. We
`undertake no obligation to update this information in light of new information, future events or otherwise. We are not
`making any representation or warranty that the information in this presentation is accurate or complete.
`
`Certain statements in this presentation, including the updated guidance presented herein, are “forward-looking statements”
`within the meaning of the federal securities laws. Words such as “may,” “will,” “should,” “would,” “could,” “believe,”
`“expects,” “anticipates,” “plans,” “intends,” “estimates,” “targets,” “projects,” “potential” or similar expressions are intended
`to identify these forward-looking statements. These statements are based on the Company’s current plans and
`expectations. Known and unknown risks, uncertainties and other factors could cause actual results to differ materially from
`those contemplated by the statements. In evaluating these statements, you should specifically consider various factors that
`may cause our actual results to differ materially from any forward-looking statements. Any top line data presented herein is
`preliminary and based solely on information available to us as of the date of this document and additional information about
`the results may be disclosed at any time. In addition, the preclinical research discussed in this presentation is preliminary
`and the outcome of such preclinical studies may not be predictive of the outcome of later trials. Any future clinical trial
`results may not demonstrate safety and efficacy sufficient to obtain regulatory approval related to the preclinical research
`findings discussed in this presentation. These risks and uncertainties are described more fully in the quarterly and annual
`reports that we file with the SEC, particularly in the sections titled “Risk Factors” and “Management’s Discussion and
`Analysis of Financial Condition and Results of Operations.” Such forward-looking statements only speak as of the date
`they are made. We undertake no obligation to publicly update or revise any forward-looking statements, whether because
`of new information, future events or otherwise, except as otherwise required by law.
`
`For Investor Use
`
`2
`
`Micro Labs Exhibit 1057-6
`
`

`

`Aerie – Building a Major Ophthalmic
`Pharmaceutical Company
`
`Aerie Late Stage IOP–Lowering Products (IP 2030+)
`
`• Rhopressa™ (netarsudil ophthalmic solution) 0.02%
`• Aerie-owned new chemical entity targeting the diseased tissue
`• PDUFA goal set for February 28, 2018; entering launch mode
`• Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%
`• Fixed combination of Rhopressa™ and latanoprost
`• Two P3’s achieved primary efficacy endpoints
`• NDA preparation underway
`Pipeline Activities
`
`• Rhopressa™
`• Potential for disease modification, 24 hour IOP lowering
`• AR-13154
`• Pre-clinical molecule for diseases of the retina
`• Drug Delivery- Front and backof the eye
`
`Data on file
`
`Product candidates have not been approved by the FDA
`
`For Investor Use
`
`3
`
`Micro Labs Exhibit 1057-7
`
`

`

`Aerie’s Lead Glaucoma Therapies
`
`RhopressaTM (netarsudil ophthalmic solution) 0.02%
`
`Positioning as Adjunctive Therapy:
`• Once-daily dosing directed at site of pathology, the trabecular meshwork
`• Consistent IOP lowering over 12 months and across a broad range of baseline
`IOPs, as demonstrated in clinical trials
`• Lowering of episcleral venous pressure, among other demonstrated attributes
`
`RoclatanTM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.05%
`
`Positioning as First Line Therapy:
`• Benefits of RhopressaTMwhile also targeting the secondary drain
`• Achieved statistical superiority to market-leading latanoprost in P3 trials
`• Potential to become the most efficacious IOP-lowering medication for
`glaucoma and ocular hypertension, if approved
`
`Data on file
`
`Product candidates have not been approved by the FDA
`
`For Investor Use
`
`4
`
`Micro Labs Exhibit 1057-8
`
`

`

`2016 US Glaucoma Market
`
`US Glaucoma Market – 2016
`$2.8B; 36M TRx, Market Share in TRx
`
`Non-PGA Market
`
`PGA Market
`
`2 – 4 Times Daily
`
`CAI
`
`AA
`
`10%
`
`Other
`
`8%
`
`Bimatoprost
`9%
`
`Travoprost
`
`8%
`
`Once Daily
`
`Fixed Combo
`
`16%
`
`36%
`
`Latanoprost
`
`13%
`
`BB
`
`36M TRx approximates
`60M units per year
`for 1.7 bottles/Rx
`
`Tafluprost
`
`PGA: Prostaglandin Analogue; BB: Beta Blocker; AA: Alpha Agonist; CAI: Carbonic Anhydrase Inhibitor
`Source: IMS Data
`
`For Investor Use
`
`5
`
`Micro Labs Exhibit 1057-9
`
`

`

`Rhopressa™ Trials Included in NDA
`Submission (PDUFA date February 28, 2018)
`
`“Rocket 1”
`3 Mo. Safety and
`Efficacy* Registration
`Trial
`U.S.
`
`Rhopressa™ 0.02% QD
`timolol BID
`(Total enrollment: 411 patients)
`
`202 patients
`209 patients
`
`*Rhopressa™ achieved non-inferiority to timolol at pre-specified secondary
`1
`endpoint range of > 20 mmHg to < 24 mmHg; also non-inferior at < 25 mmHg
`
`“Rocket 2”
`12 Mo. Safety, 3 Mo.
`Interim Efficacy**
`Registration Trial
`U.S.
`
`Rhopressa™ 0.02% QD
`Rhopressa™ 0.02% BID
`timolol BID
`(Total enrollment: 756 patients)
`
`251 patients
`254 patients
`251 patients
`
`**Rhopressa™ achieved non-inferiority to timolol at primary endpoint range
`of > 20 mmHg to < 25 mmHg
`
`1 Post-hoc analysis
`ClinicalTrials.gov Identifier: NCT02207491, NCT02207621
`
`Product candidates have not been approved by the FDA
`
`For Investor Use
`
`6
`
`Micro Labs Exhibit 1057-10
`
`

`

`Additional Rhopressa™ Phase 3 Trial Data Included in NDA:
`Rocket 4 Under Review; Mercury 1 Supportive
`
`“Rocket 4”
`6 Mo. Safety, 3 Mo.
`Interim Efficacy* Trial
`
`Rhopressa™ 0.02% QD
`timolol BID
`
`351 patients
`357 patients
`
`
`*RhopressaTMachieved non-inferiority to timolol at primary endpoint range of > 20*RhopressaTMachieved non-inferiority to timolol at primary endpoint range of > 20
`
`mmHg to < 25 mmHg; also non-inferior up to < 30 mmHg; consistent safety resultsmmHg to < 25 mmHg; also non-inferior up to < 30 mmHg; consistent safety results
`
`“Mercury 1”
`12 Mo. Safety, 3 Mo.
`Interim Efficacy**
`Registration Trial
`
`Roclatan™ 0.02%/0.005% QD 238 patients
`RhopressaTM 0.02% QD 244 patients
`latanoprostQD
`236 patients
`
`
`**Rhopressa TM achieved non-inferiority to latanoprost at **Rhopressa TM achieved non-inferiority to latanoprost at
`
`range of > 20 mmHg to < 25 mmHgrange of > 20 mmHg to < 25 mmHg
`
`ClinicalTrials.gov Identifier: NCT02246764, NCT02558374
`
`Product candidates have not been approved by the FDA
`
`For Investor Use
`
`7
`
`Micro Labs Exhibit 1057-11
`
`

`

`Rocket 2: Safety/Tolerability Overview of
`RhopressaTM QD (Interim 12-Month)
`
`• There were no drug-related systemic or serious adverse events
`
`• The most common adverse event was conjunctival hyperemia with
`~50% incidence*, the majority mild and sporadic
`
`• Other ocular AEs
`• AEs occurring in ~5-23% of patients included: conjunctival
`hemorrhage, cornea verticillata, blurry vision and reduced visual
`acuity
`
`Product candidates have not been approved by the FDA
`
`For Investor Use
`
`8
`
`Micro Labs Exhibit 1057-12
`
`

`

`Rhopressa™ Commercialization Prep
`
`Hired Chief Commercial Officer and VPs of Sales, Market Access,
`Commercial Operations, and Medical Affairs in late 2016 / early
`2017, and Chief Compliance Officer in 2015
`
`Expect to hire U.S. salesforce of 100 reps immediately after
`approval; fully trained by end of 2Q18
`- Target top 12,000 prescribers; 80% of Rx’s
`
`Commenced initial scientific market access meetings with top
`Medicare Part D / Commercial Payors
`
`Developing launch plan
`
`Product candidates have not been approved by FDA
`
`For Investor Use
`
`99
`
`Micro Labs Exhibit 1057-13
`
`

`

`Building Aerie’s Presence in the
`Medical Community
`
`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
`
`5 Posters, including Enhancing Efficacy
`by Continuous Delivery of AR-13154 in
`an Animal Model of Proliferative Diabetic
`Retinopathy, Carbajal et al.
`
`4 Presentations, including 24 Hour IOP
`Lowering of Netarsudil, Peace et al.
`Data on File
`
`10
`
`Micro Labs Exhibit 1057-14
`
`

`

`RoclatanTM U.S. Registration Trial Results
`
`“Mercury 1”
`12 Mo. Safety, 3 Mo.
`Interim Efficacy*
`Registration Trial
`
`RoclatanTM 0.02%/0.005% QD238 patients
`RhopressaTM 0.02% QD
`244 patients
`latanoprost QD 236 patients
`
`*Roclatan TMachieved statistical superiority to components at primary endpoint
`range of > 20 mmHg to < 36 mmHg
`
`“Mercury 2”
`3 Mo. Safety and
`Efficacy**
`Registration Trial
`
`Same structure as Mercury 1, except 3 months
`RoclatanTM 0.02%/0.005% QD 245 patients
`RhopressaTM 0.02% QD
`255 patients
`latanoprost QD
`250 patients
`
`**Roclatan TMachieved statistical superiority to components at primary endpoint
`range of > 20 mmHg to < 36 mmHg, similar to Mercury 1
`
`ClinicalTrials.gov Identifier: NCT02558400, NCT02674854 Product candidates have not been approved by the FDA
`
`For Investor Use
`
`11
`
`Micro Labs Exhibit 1057-15
`
`

`

`Roclatan™ 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%
`
`27%
`
`26%
`
`22%
`
`20%
`
`16%
`
`12%
`
`82%
`
`72%
`
`66%
`
`57%
`
`60%
`
`49%
`
`49%
`
`43%
`
`37%
`
`35%
`
`0%
`
`14 mmHg
`
`Rhopressa™ (n=148)
`*p<0.05, **p<0.01, ***p<0.0001
`++Data on File
`Based on Mercury 1 Topline 12-month
`
`16 mmHg
`15 mmHg
`IOP on Treatment
`Latanoprost (n=203)
`
`17 mmHg
`
`18 mmHg
`
`Roclatan™ (n=158)
`
`Product candidates have not approved by the FDA
`
`For Investor Use
`
`12
`
`Micro Labs Exhibit 1057-16
`
`

`

`Mercury 1: Safety/Tolerability Overview of
`RoclatanTM QD Topline 12 Month
`
`• There were no drug-related systemic or serious adverse events
`
`• The most common adverse event was conjunctival hyperemia with
`~60% incidence, scored as mild on biomicroscopy for ~70% of these
`patients and sporadic
`
`• Other ocular AEs
`– AEs occurring in ~5-18% of subjects receiving RoclatanTM
`included: cornea verticillata, conjunctival hemorrhage, eye
`pruritus, lacrimation increased, visual acuity reduced, blepharitis
`and punctate keratitis.
`
`++Data on File
`Based on Mercury 1 Topline 12-month
`
`Product candidates have not approved by the FDA
`
`For Investor Use
`
`13
`
`Micro Labs Exhibit 1057-17
`
`

`

`Roclatan™ Next Steps
`
`• Roclatan™ NDA filing expected 1H 2018
`
`• Aerie Ireland plant and 2 contract manufacturers are
`expected to support Roclatan™ U.S. commercial activities
`
`• Mercury 3 commenced in Europe 3Q 2017
`- Trial conducted in U.K., France, Germany, Italy, Spain and Belgium
`
`- Regulatory submission in Europe expected in 2H 2019
`
`Product candidates have not been approved by FDA
`
`For Investor Use
`
`14
`
`Micro Labs Exhibit 1057-18
`
`

`

`Expanding Aerie Franchise to Europe and
`Japan
`• Europe (‘16 Glaucoma Market: 128M monthly units, >2X U.S.)
`• Expect to file EU MAA for Rhopressa™ in 2018
`• Current clinical plan expected to satisfy EU regulatory requirements
`(includingRocket 4 for Rhopressa™ andMercury3 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
`(Ganfort®) started 3Q 2017. Approximately 250 patients per arm.
`
`• Commenced construction of Ireland Plant to support worldwide commercial
`supply
`
`• Japan (‘16 Glaucoma Market: 52M monthly units)
`• Preparing to advance clinical development on our own
`
`• Phases 1 and 2 to be conducted on Japanese / Japanese Americans
`
`• Phase 3 trials expected to be conducted in Japan commencing 2H 2018
`
`For Investor Use
`
`15
`
`Micro Labs Exhibit 1057-19
`
`

`

`Advancing the Pipeline
`
`• Rhopressa™
`• Potential for disease modification in glaucoma
`• 24-hour IOP lowering
`
`• AR-13154 (and related compounds)
`• Potential opportunity for Aerie retina program
`
`• Drug Delivery
`• Back of the eye implants for retinal diseases
`• Front of the eye implants for glaucoma
`
`Product candidates have not been approved by FDA
`
`For Investor Use
`
`16
`
`Micro Labs Exhibit 1057-20
`
`

`

`Netarsudil* Blocks TGF-beta-Induced Expression of
`Fibrosis Proteins in Cultured Human TM Cells
`
`*Active ingredient of
`Rhopressa™
`
`TGF-beta Levels are Elevated in the Aqueous Humor of
`Patients with Glaucoma
`2; SMA: Smooth muscle actin; FSP1: Fibroblast-specific protein 1
`• TGF 2: Transforming growth factor
`• Lin, C-W et. al., J. Ocul Pharmacol Ther (2017) – in press
`
`Product candidates have not been approved by FDA
`
`Data on File
`
`For
`Investor
`Use
`
`17
`
`Micro Labs Exhibit 1057-21
`
`

`

`Netarsudil* Causes Expansion of TM Tissue,
`Opening Spaces for Increased Outflow
`
`Control
`
`+ Netarsudil
`
`TM: Trabecular Meshwork
`SC: Schlemm’s Canal
`Control = buffered saline solution
`
`Increasing Trabecular Outflow, Reducing Fibrosis Could Stop
`Degeneration of Outflow Tissues in Glaucoma
`*Active ingredient of Rhopressa™
`Source: Ren R et al.
`Invest Ophthalmol Vis Sci. 2016; 57(14):6197-6209.
`
`Product candidates have not been approved by FDA
`
`For Investor
`Use
`
`18
`
`Micro Labs Exhibit 1057-22
`
`

`

`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
`
`Product candidates
`have not been
`approved by FDA
`
`• Netarsudil (active ingredient of Rhopressa™) equally effective during
`nocturnal and diurnal periods
`• Current glaucoma medications either have no efficacy at night (beta
`blockers, alpha agonists) or reduced efficacy at night (PGAs, CAIs)1 - 6
`
`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 1057-23
`
`

`

`Retina Program: AR-13154 Efficacy Driven
`Primarily by ROCK, PKC Inhibition
`
`Active
`
`ROCK
`PKC
`
`Inactive
`
`AR-13154
`
`ROCK JAK
`PKC PDGFR
`
`Retinal
`Esterases
`
`• 182 Aerie compounds
`screened against 469
`human kinases
`• AR-13154 identified as
`potent lead compound
`
`Retinal tissue harvested
`from OIR mouse model
`AR-13154 effectively
`converted to active
`metabolite by esterases
`Active metabolite keeps
`ROCK, PKC activity,
`loses PDGFR, JAK
`activity
`ROCK/PKC Action:
`Vascular Dysfunction
`and Fibrosis
`ROCK Action:
`Inflammation
`
`Data on file; Carbajal, KS et al., Enhancing Efficacy by Continuous Delivery of AR-13154(S) in an Animal Model of Proliferative Diabetic
`For Investor Use
`Product candidates have not been approved by FDA
`Retinopathy, ARVO 2017, Poster B0481.
`
`Data on File
`
`20
`
`Micro Labs Exhibit 1057-24
`
`

`

`Topical AR-13154(S) Provides Additive Efficacy to
`Eylea® in Proliferative Diabetic Retinopathy Model
`
`Oxygen-induced
`retinopathy model of
`PDR (mouse)
`0.06% AR-13154(S)
`delivered topically
`from P12 to P17
`
`Confirms AR-13154(S)
`potential as
`monotherapy and as
`adjunct to anti-VEGF
`therapies; not yet
`tested in humans
`
`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)
`
`For more information on Eylea®
`please see the product webpage
`https://www.eylea.us/
`
`120%
`
`100%
`
`80%
`60%
`
`40%
`
`20%
`0%
`
`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.
`
`Product candidates have not been approved by FDA
`For Investor Use
`
`21
`
`Micro Labs Exhibit 1057-25
`
`

`

`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-13154 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
`
`Product candidates have not been approved by FDA
`
`For Investor Use
`
`22
`
`Micro Labs Exhibit 1057-26
`
`

`

`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
`
`23
`
`Micro Labs Exhibit 1057-27
`
`

`

`Summary
`• Key Clinical Priorities
`• RhopressaTM: PDUFA date set for February 28, 2018
`
`• RoclatanTM: Mercury 3 commenced 3Q 2017 (EU)
`U.S. NDA filing expected in 1H 2018
`• Research Initiatives
`• Rhopressa™ disease modification, 24-hour IOP lowering, sustained release
`AR-13154 and related compounds with potential for retinal diseases
`•
`Evaluating Aerie’s 3,000+ proprietary Rho kinase molecules
`•
`• Business Development and Expansion Opportunities
`• Drug delivery opportunities for front and back of the eye (e.g., DSM)
`EU/JP clinical path and commercialization strategy
`•
`Ireland Manufacturing Facility
`•
`• Well-Financed: $308M cash and investments at 6/30/17
`
`For Investor Use
`
`24
`
`Micro Labs Exhibit 1057-28
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`

`

`RhopressaTM and RoclatanTM
`Key Milestones
`
`2H-2018: Rhopressa™
`Potential P3 Commencement in Japan
`
`Q1-2017: Rhopressa™
`NDA Resubmitted
`
`1H-2018: Rhopressa™
`Potential U.S. Approval and Launch
`
`Q2-2017: Rhopressa™
`Rocket 4 Topline safety (6 mos)
`
`2H-2018: Rhopressa™
`Potential EU MAA Filing
`
`2017
`
`2018
`
`Q2-2017: Roclatan™
`P3 Mercury 2
`Topline Efficacy (3 mos)
`
`1H-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
`
`Product candidates have not been approved by the FDA
`
`For Investor Use
`
`25
`
`Micro Labs Exhibit 1057-29
`
`