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Investor day deck master revised 09282017
1.
1 | Investor
Day | September 14, 2017 | © 2017 Glaukos Corporation 1 Investor Day September 2017
2.
2 | Investor
Day | September 14, 2017 | © 2017 Glaukos Corporation MIGS AND BEYOND Delivering Novel Surgical & Pharmaceutical Glaucoma Therapy
3.
3 | Investor
Day | September 14, 2017 | © 2017 Glaukos Corporation All statements other than statements of historical facts included in this presentation that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for forward-looking statements contained herein, we caution you that they are based on current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control, that may cause our actual results to differ materially from those expressed or implied by forward-looking statements in this presentation. These potential risks and uncertainties include, without limitation, uncertainties about our ability to maintain profitability; our dependence on the success and market acceptance of the iStent®; our ability to leverage our sales and marketing infrastructure to increase market penetration and acceptance both in the United States and internationally of our products; our dependence on a limited number of third-party suppliers for components of our products; the occurrence of a crippling accident, natural disaster or other disruption at our primary facility, which may materially affect our manufacturing capacity and operations; maintaining adequate coverage or reimbursement by third-party payors for procedures using the iStent or other products in development; our ability to properly train, and gain acceptance and trust from, ophthalmic surgeons in the use of our products; our ability to successfully develop and commercialize additional products; our ability to compete effectively in the highly competitive and rapidly changing medical device industry and against current and future competitors (including MIGS competitors) that are large public companies or divisions of publicly traded companies that have competitive advantages; the timing, effect and expense of navigating different regulatory approval processes as we develop additional products and penetrate foreign markets; the impact of any product liability claims against us and any related litigation; the effect of the extensive and increasing federal and state regulation in the healthcare industry on us and our suppliers; the lengthy and expensive clinical trial process and the uncertainty of outcomes from any particular clinical trial; our ability to protect, and the expense and time-consuming nature of protecting, our intellectual property against third parties and competitors that could develop and commercialize similar or identical products; the impact of any claims against us of infringement or misappropriation of third party intellectual property rights and any related litigation; and the market’s perception of our limited operating history as a public company. These and other known risks, uncertainties and factors are described in detail under the caption “Risk Factors” and elsewhere in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for 2016 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2017. Our filings with the Securities and Exchange Commission are available in the Investor Section of our website at www.glaukos.com or at www.sec.gov. In addition, information about the risks and benefits of our products is available on our website at www.glaukos.gov. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof. We do not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law. Disclaimer
4.
4 | Investor
Day | September 14, 2017 | © 2017 Glaukos Corporation Investor Day Presenters and Panelists Guest Surgeons Eric Donnenfeld MD John Berdahl MD Glaukos Management Tom Burns, President & CEO Chris Calcaterra, COO Joe Gilliam, CFO & SVP Corporate Development Dave Haffner, SVP New Technologies Hal Heitzmann PhD, SVP Applied Research & Engineering Jeff Wells PharmD, SVP Regulatory, Quality & Clinical Affairs
5.
5 | Investor
Day | September 14, 2017 | © 2017 Glaukos Corporation Agenda SUBJECT TIME 8:05 8:20 9:20 9:50 10:10 10:30 10:50 11:10 Transforming Glaucoma Therapy Our Solutions Portfolio Q&A Session 1 Break Our Market Opportunity Our Global Commercialization Platform Development & Summary Q&A Session 2
6.
6 | Investor
Day | September 14, 2017 | © 2017 Glaukos Corporation MIGS AND BEYOND Transforming Glaucoma Therapy
7.
7 | Investor
Day | September 14, 2017 | © 2017 Glaukos Corporation Glaukos is Transforming Glaucoma Therapy To pioneer and lead the global glaucoma market with micro-scale injectable therapies that advance the standard-of-care and enrich the lives and treatment alternatives for glaucoma patients worldwide. OUR MISSION OUR STRATEGY Grow Deliver Extend US adoption of our proprietary Micro- Invasive Glaucoma Surgery (MIGS) technology Our pipeline of iStent® flow devices and the Travoprost iDoseTM drug delivery system Our global reach into high-value international markets Transition Into a hybrid pharma/device leader with micro-scale flow, drug delivery and biosensor platforms
8.
8 | Investor
Day | September 14, 2017 | © 2017 Glaukos Corporation Intuitive Answer to Unmet Need Recognized drawbacks with existing glaucoma treatments and lack of interventional innovation Identified novel, ab interno approach to restoring natural outflow Engineering Perseverance Overcame significant challenges of micro- scale prototype development and subsequent Swiss screw machining requirements Clinical & Regulatory Excellence Pursued mild to moderate glaucoma indication, despite more rigorous and lengthy regulatory path Built extensive body of clinical evidence; established and validated titratable therapy Transforming the Algorithm Recognized role of drug delivery platforms and combination MIGS therapies to manage full range of glaucoma severity 1999 Strategic Commercial Execution Assembled seasoned sales force, conducted extensive physician training Received FDA approval, secured full Medicare and major private payer reimbursement for flagship iStent device 2001-Current 2004-Current 2012-Current Market-Expanding Pipeline Built deep pipeline focused on injectable therapies and broad glaucoma patient populations 2001-Current 2009-Current Building The MIGS Market
9.
9 | Investor
Day | September 14, 2017 | © 2017 Glaukos Corporation Proceeds enabled accelerated investments in our pipeline and global expansion GKOS – June 24, 2015
10.
10 | Investor
Day | September 14, 2017 | © 2017 Glaukos Corporation $0 $5 $10 $15 $20 $25 $30 $35 $40 $45 Q1 2013 Q2 2013 Q3 2013 Q4 2013 Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015 Q2 2015 Q3 2015 Q4 2015 Q1 2016 Q2 2016 Q3 2016 Q4 2016 Q1 2017 Q2 2017 Total Net Sales (in millions) 87%Gross Margin* $104MCash & Short-Term Equivalents* * As of 6/30/2017 Demonstrated Financial Performance $21.0 $45.6 $71.7 $114.4
11.
11 | Investor
Day | September 14, 2017 | © 2017 Glaukos Corporation Key Metric 6/30/15 6/30/17 % Growth Progress Since IPO US surgeons trained (approx.) Prospective clinical trials underway Commercial sales personnel worldwide 1,300 18 65 2,750 21 171 17% Articles in peer-reviewed journals 33 62 88% Key Numbers 112% 163% $5 billion global glaucoma market served 300,000+ iStents implanted globally 15 countries with direct Glaukos sales operations 200+ issued, licensed or pending Glaukos patents 4 new Glaukos glaucoma products currently being evaluated by FDA $5b 300k 15 200+ 4
12.
12 | Investor
Day | September 14, 2017 | © 2017 Glaukos Corporation Building MIGS Marketplace and Investing for the Future Overcoming Headwinds Commercial insurance coverage Hurricanes Irma / Harvey Australia Competition Noridian Revised Net Sales Guidance: Q3: $38-40M FY 2017: $155-160M
13.
13 | Investor
Day | September 14, 2017 | © 2017 Glaukos Corporation Open-Angle Glaucoma Disease is chronic, progressive, irreversible and largely asymptomatic Typically associated with elevated intraocular pressure (IOP) Elevated IOP causes optic nerve damage and leads to vision loss Reducing IOP is only proven treatment N O R M A L V I S I O N W I T H G L A U C O M A
14.
14 | Investor
Day | September 14, 2017 | © 2017 Glaukos Corporation Grant M. Arch Ophthalmology 1963 Zhou J. Journal of Glaucoma 2005 Rosenquist R et al Curr Eye Res 1989 SC Bypass TM AC EV CC X Bypassing the Trabecular Meshwork Early ex vivo experiments and mathematical models showed that a single long-lasting patent trabecular bypass could improve conventional outflow facility, resulting in reductions in IOP
15.
15 | Investor
Day | September 14, 2017 | © 2017 Glaukos Corporation Targeted Trabecular Bypass Placement A majority of aqueous veins are found in the inferonasal quadrant A single trabecular bypass in that location accesses the majority of aqueous veins Areas of high segmental outflow are recognized by aqueous vein locations and regions of meshwork hyperpigmentation Intelligent trabecular stent placement may further enhance outflow facility
16.
16 | Investor
Day | September 14, 2017 | © 2017 Glaukos Corporation FDA approved in 2012; implanted in conjunction with cataract surgery Smallest device known to be implanted in the human body (1.0 mm x 0.33 mm) Heparin-coated stent, pre-loaded in inserter Ergonomic rail design protects and accesses underlying collector channels in Schlemm’s canal; retention arches help ensure secure placement Prolonged reduction in IOP, combined with excellent safety profile Overcomes many of the drawbacks of conventional treatment options Initial indication in combination with cataract surgery creates revenue to drive pipeline and platform development First-Ever Micro-Invasive Glaucoma Surgery Device
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Day | September 14, 2017 | © 2017 Glaukos Corporation 23.4 13.9 14.3 14.9 12 16 20 24 Preop Month 12 Month 24 Month 36 iStent + Cataract Surgery MeanIOPmmHg Consistent cohort (n=39) achieved 36% reduction in mean medicated IOP and 86% reduction in mean meds Neuhann T, J Cataract Refract Surg 2015 Real-World Clinical Experience: Western Europe (3-Year Data) US PIVOTAL iSTENT STATS Preop medicated mean IOP of 18.7 mm Hg At M12, mean IOP of 17.0 mm Hg on 0.2 mean meds vs. 1.6 preop medications Mean Meds 1.9 0.3
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Day | September 14, 2017 | © 2017 Glaukos Corporation Real-World Clinical Experience: Western Europe (5-Year Data) iStent + Cataract Surgery Case series showed 16% reduction in mean medicated IOP; after mean follow-up of 54 months, 42% of patients were medication free Arriola-Villalobos P et al British Journal of Ophthalmology 2012 MeanIOPmmHg 19.4 17.4 16.1 15.9 16.5 16.1 16.3 12 16 20 Preop (n=19) Year 1 (n=19) Year 2 (n=19) Year 3 (n=19) Year 4 (n=16) Year 5 (n=13) Final (n=19) Remained medication free 42%
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Day | September 14, 2017 | © 2017 Glaukos Corporation Real-World Clinical Experience: US (2-Year Data) iStent + Cataract Surgery Consistent cohort of 107 OAG eyes followed through 2 years achieved mean IOP reduction of 22% and 56% reduction in mean medications Ferguson J Berdahl J Clinical Ophthalmology 2016 MeanIOPmmHg 19.3 16.4 15.7 16.4 16.3 15.2 12 16 20 24 Preop (n=107) 1M (n=102) 6M (n=82) 12M (n=98) 18M (n=77) 24M (n=107) Reduction in mean # of meds 56%
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Day | September 14, 2017 | © 2017 Glaukos Corporation Potential to transform glaucoma therapy with MIGS and sustained delivery Rx therapies Elegant micro-invasive solutions to address rampant non-adherence issues in glaucoma Algorithm-based therapeutic approach that utilizes drugs and devices to optimize treatment based upon disease stage severity Delivering Novel Surgical & Pharmaceutical Glaucoma Therapy
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Day | September 14, 2017 | © 2017 Glaukos Corporation MIGS AND BEYOND Our Solutions Portfolio
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Day | September 14, 2017 | © 2017 Glaukos Corporation Ocular Hypertension IOP of 21-30 mm Hg Target IOP 20% ↓ from baseline; ≤ 18 mm Hg Treatment 0-1 med Mild OAG IOP of 25-30 mm Hg with minor optic nerve damage and visual field loss Moderate OAG IOP of > 30 mm Hg with moderate optic nerve damage and visual field loss Advanced OAG Uncontrolled IOP with significant optic nerve damage and visual field loss Refractory OAG Uncontrolled IOP with severe optic nerve damage and visual field loss IOP is measured in millimeters of mercury (mm Hg). Normal IOP in healthy eyes ranges from 10-21 mm Hg. Current OAG Treatment Algorithm 1 2 34 5 Open-Angle Glaucoma Progression Target IOP 25% ↓ from baseline; ≤ 18 mm Hg Treatment ~ 1 med, laser, MIGS Target IOP 30% ↓ from baseline; ≤ 15 mm Hg Treatment ~ 2 meds, laser, MIGS Target IOP 35% ↓ from baseline; < 15 mm Hg Treatment ~ 3 meds, filtering surgery, tube shunt Target IOP 35% ↓ from baseline; < 15 mm Hg (ideally ~ 12 mm Hg) Treatment 3+ meds, filtering surgery, tube shunt
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Day | September 14, 2017 | © 2017 Glaukos Corporation OAG Progression OCULAR HYPERTENSION MILD MODERATEADVANCED REFRACTORY Addressing full range of glaucoma disease states and progression Injectable drug delivery implant; sustained drug therapy for extended periods Envision use alone or in combination with other MIGS devices Injectable 2-stent therapy for standalone procedures Injectable 2-stent therapy for combo- cataract procedures Accesses secondary outflow pathway; envision use primarily in combination with other MIGS devices Injectable 3-stent therapy for standalone procedures Portfolio of Micro-Scale Injectable Therapy REFRACTORYADVANCEDMODERATEMILD OCULAR HYPERTENSION Single stent therapy for combo-cataract procedures iStent Inject, iStent SA, iStent Supra, iStent infinite and iDose are not approved by the FDA.
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Day | September 14, 2017 | © 2017 Glaukos Corporation OAG Progression OCULAR HYPERTENSION MILD MODERATEADVANCED REFRACTORY Addressing full range of glaucoma disease states and progression 2022-23 2020-21 2H 2018 2020 2020-21 Portfolio of Micro-Scale Injectable Therapy: Estimated US Commercialization REFRACTORYADVANCEDMODERATEMILD OCULAR HYPERTENSION 2012 iStent Inject, iStent SA, iStent Supra, iStent infinite and iDose are not approved by the FDA.
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Day | September 14, 2017 | © 2017 Glaukos Corporation BEYOND MIGS Glaukos Pharmaceuticals
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Day | September 14, 2017 | © 2017 Glaukos Corporation OAG Progression OCULAR HYPERTENSION MILD MODERATEADVANCED REFRACTORY Injectable drug delivery implant; sustained drug therapy for extended periods Envision use alone or in combination with other MIGS devices Beyond MIGS: Micro-Scale Rx Injectable Therapy Platform REFRACTORYADVANCEDMODERATEMILD OCULAR HYPERTENSION iDose is not approved by the FDA.
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Day | September 14, 2017 | © 2017 Glaukos Corporation Understanding the Problem Non-adherence to topical glaucoma medications is ubiquitous Reasons for patient non- adherence are varied Elevated IOP due to non- adherence leads to glaucoma progress and vision loss Statistics1 10-25% of newly prescribed patients don’t refill their 2nd prescription ~40-60% of newly prescribed patients are still taking their meds at end of year 1 70-75% compliance reported for “compliant” patients 1 Quigley HA Glaucoma: What Every Patient Should Know 2011; Friedman DS et al Invest Ophthalmol Vis Sci. 2007; Glaucoma Research Foundation; Market Scope 2 AGIS Investigators Am J Ophthalmol. 2000; Leske MC et al Arch Ophthalmol. 2003; Blalock S et al Ophthalmology 2011; Olthhoff et al Ophthalmology 2005 Reasons1 Complex dosing regimens, especially for patients on multiple topical medications Cost and forgetfulness Difficulty properly instilling drops, especially in elderly patient population Adverse side effects and/or intolerance with topical medications Inconvenience and/or misunderstanding about the need Value of Adherence to Therapy2 Lowering IOP is the only proven method of treating glaucoma Multiple studies have shown that low IOP is associated with reduced progression of optic nerve damage and visual field defect The risk of progression decreases about 10% with each mm Hg of IOP reduction from baseline Patients with poor glaucoma medication adherence are shown to have worse visual field defect severity Tom
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Day | September 14, 2017 | © 2017 Glaukos Corporation Drug Reservoir Scleral Anchor Retaining Cap Elution Membrane Titanium implant (1.8 mm x 0.5 mm) designed for continuous drug delivery directly into anterior chamber Filled with proprietary, novel and uber-potent formulation of travoprost; membrane-controlled Fickian elution; zero-order rates demonstrated in vitro and in vivo Elegant and facile injectable procedure; bypassing cornea allows for micro-elution rates to achieve therapeutic index Anchor keeps device in place and facilitates straightforward exchange upon drug depletion OAG Progression OCULAR HYPERTENSION MILD MODERATEADVANCED REFRACTORY iDose Travoprost: First-of-a-Kind Intraocular Drug Delivery Device iDose is not approved by the FDA.
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Day | September 14, 2017 | © 2017 Glaukos Corporation 01 Select and formulate unique, potent and long-lasting prostaglandin analog that converts into active metabolite 02 Develop micro-scale elution system that could deliver predictable levels of micro-elution rates at near zero-order 03 Attain proof-of-concept in cynomolgus monkey and in first pilot human studies Figure 1 Travoprost chemical structure. Notes: (A) Travoprost prodrug. (B) Travoprost free acid, after hydrolysis of isopropyl ester in carbon-I position. Critical iDose Travoprost Milestones
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Day | September 14, 2017 | © 2017 Glaukos Corporation iDose Travoprost Procedure iDose is not approved by the FDA.
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Day | September 14, 2017 | © 2017 Glaukos Corporation iDose Travoprost Exchange (Removal) Procedure iDose is not approved by the FDA.
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Day | September 14, 2017 | © 2017 Glaukos Corporation iDose Travoprost Why choose Travoprost as basis for proprietary formulation? Travoprost is highly effective prostaglandin analog • Typical IOP reduction with topical travoprost is 7-8 mm Hg and sustained reduction has been demonstrated through at least 5 years of continuous use • Travoprost lowers IOP throughout the 24-hour daily cycle Travoprost, a prodrug, is almost entirely converted to the more potent free acid by intraocular esterase enzymes Travoprost free acid is biologically active at very low concentrations • Potency: EC50 ≈ 2 nM • Aqueous humor Cmax ≈ 3-4 nM after topical application These characteristics allow a tiny amount of travoprost to be stored in a micro-miniature implant and slowly released to provide prolonged therapy Intracameral delivery may minimize side effects associated with topical prostaglandin analogs iDose is not approved by the FDA.
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Day | September 14, 2017 | © 2017 Glaukos Corporation US Topical Glaucoma Medication Market Share Prostaglandin analogs are most common first-line medication for management of IOP Class consists of latanoprost, bimatoprost, travoprost and tafluprost Prostaglandins Beta Blockers Alpha Agonists Combination Drugs Other Market Scope – Glaucoma Medication Prescription Shares in US per IMS Data 53% 13% 10% 16% 8%
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Day | September 14, 2017 | © 2017 Glaukos Corporation Our approach to creating the optimal solution and defining success Micro-Scale Rx Injectable Therapy Platform Clinical Goals To achieve non-inferiority IOP reduction (comparable results) to existing topical glaucoma therapies To provide a maximal therapeutic period of IOP control (minimum of 6 months) To minimize side effects and adverse events Medical Needs 01. Compliance 02. Duration 03. Favorable benefit-to-risk
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Day | September 14, 2017 | © 2017 Glaukos Corporation iDose Travoprost International Pilot Study International pilot, proof-of-concept, prospective study Part I 10 non-sighted patients implanted; Endothelial cell density (ECD) measurements taken after planned explants showed negligible ECD loss; demonstrated feasibility of implant and replace concept Part II 59 OAG subjects randomized to receive 2 elution rates of iDose Travoprost or topical eye drops Both the slow- and fast-eluting implants demonstrated comparable efficacy to topical travoprost at 1 year Single-site, single-surgeon evaluation in pre-selected travoprost responders not directly comparable to US Phase II “all comers” trial US IDE opened in 30 days on basis of preclinical work and the pilot international clinical study iDose is not approved by the FDA.
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Day | September 14, 2017 | © 2017 Glaukos Corporation US iDose Travoprost: Standards for Efficacy and Choice of Comparator …For the pivotal trials, “efficacy would be demonstrated by either equivalence or superiority to the comparator ( a prostaglandin or timolol 0.5% eye drop) at Week 1(or 2), Week 6, and Week 12. Equivalence is defined as the two-sided 95% confidence interval being less than 1.5 mm Hg at each direct group comparison over multiple times over the 12 week period and being less than 1.0 mm Hg for the majority of direct group comparisons”…. US FDA Standard for Efficacy – US FDA Choice of Comparator Ophthalmic Brand/API Xalatan® (latanoprost) Pharmacia/Pfizer Timolol 0.5% bid Travatan® (travoprost) Alcon/Novartis Timolol 0.5% bid Pivotal Trial Comparator 1996 2001 Approval Date Company Lumigan® (bimatoprost) Allergan Timolol 0.5% bid 2001 Zioptan® (travoprost) Santen/Merck Timolol 0.5% bid 2012 RhopressaTM (netarsudil) Aerie Timolol 0.5% bid TBD
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Day | September 14, 2017 | © 2017 Glaukos Corporation 27.4 25.8 25.3 20.8 20.0 20.0 20.3 19.7 20.7 19.8 19.6 20.5 19.5 20.1 12.0 14.0 16.0 18.0 20.0 22.0 24.0 26.0 28.0 BL 8 am BL 10 am BL 4 pm W2 8 am W2 10 am W2 4 pm W6 8 am W6 10 am W12 8 am W12 10 am W12 4 pm M6 8 am M6 10 am M6 4 pm Timoptic 0.5% Travatan 0.004% Pivotal Trial Data (Study C97-72) MeanIOPmmHg Recent Timolol IOP Results Appear Superior to Prior Trials Netarsudil (Rhopressa 0.2%) misses non-inferiority endpoint to timolol 0.5% at 3 months in Rocket 1 Phase III trial in patients with baseline IOPs from 20- 27 mm Hg…. Aerie Pharmaceuticals* April 23, 2015 *In Aerie’s Rocket 4 trial, Rhopressa™ did demonstrate non-inferiority to Timolol in patients with baseline IOPs from above 20 mm Hg to below 30 mm Hg
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Day | September 14, 2017 | © 2017 Glaukos Corporation 27.2 25.5 25.0 19.2 18.2 17.6 19.4 18.1 19.7 18.5 18.1 20.1 18.9 18.5 27.4 25.8 25.3 20.8 20.0 20.0 20.3 19.7 20.7 19.8 19.6 20.5 19.5 20.1 12.0 14.0 16.0 18.0 20.0 22.0 24.0 26.0 28.0 BL 8 am BL 10 am BL 4 pm W2 8 am W2 10 am W2 4 pm W6 8 am W6 10 am W12 8 am W12 10 am W12 8 am M6 8 am M6 10 am M6 4 pm Travatan 0.004% Timoptic 0.5% Travatan 0.004% Pivotal Trial Data (Study C97-72) “In clinical trials...Travatan or Travatan Z dosed once daily in the evening demonstrated 7-8 mm Hg reductions in IOP” MeanIOPmmHg Prostaglandins Shown to Reduce IOP 7-8 mm Hg Travatan Z Package Insert
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Day | September 14, 2017 | © 2017 Glaukos Corporation US Phase II iDose Travoprost Study Design Duration • 12-week unmask, 3-year study follow-up Selected Inclusion Criteria • ≥ 18 years of age, phakic or pseudophakic • Diagnosis of mild to moderate open-angle glaucoma, or ocular hypertension, on 0 to 3 meds • Baseline IOP between 21 mm Hg and 36 mm Hg Selected Exclusion Criteria • Diagnosis of traumatic, uveitic, neovascular or angle-closure glaucoma • Corneal, retinal or systemic conditions that might confound study results Efficacy Measures/Methods • Day 1 and Month 1 IOP, with diurnals (8:00, 10:00, 16:00) at Weeks 2, 6 and 12 • Meds to be added if IOP > 18 mm Hg at Month 1 post-op Safety Reporting • Surgical and post-op adverse events • Blood plasma References: US IND #120995; NCT 02754596 Randomization n=150 1:1:1 Fast Elution Implant+ Placebo Eye Drops Slow Elution Implant + Placebo Eye Drops Sham Surgery + Timolol 0.5% Eye Drops b.i.d. iDose is not approved by the FDA.
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Day | September 14, 2017 | © 2017 Glaukos Corporation iDose Travoprost US Phase II: Preliminary Efficacy Results (n=154) 10 15 20 25 30 35 40 Baseline Week 2 Week 6 Week 12 98% 88% 82% 96% 85% 82% 100% 82% 74% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Week 2 Week 6 Week 12 iDose is not approved by the FDA. Subjects without Additional Medications through Week 12 Mean IOP Fast Elution Slow Elution Timolol 0.5% Implant Week 12 Mean IOP Fast-Elution (n=51) Slow-Elution (n=54) 17.4 mm Hg 17.3 mm Hg IOP Reduction At Week 12 31% 30% Fast Elution Slow Elution Timolol 0.5%
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Day | September 14, 2017 | © 2017 Glaukos Corporation Fast Elution Slow Elution Timolol 0.5% Average IOP reductions through 12 weeks post-op ranging from 8.0 to 9.5 mm Hg in the implant arms iDose Travoprost US Phase II: Preliminary Efficacy Results 9.5 8.7 8.58.7 8.2 8.0 7.5 7.5 7.6 0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 10.0 Week 2 Week 6 Week 12 iDose is not approved by the FDA. Average IOP Reductions from Baseline* *Calculated using all IOP observations through each data point weighted equally
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Day | September 14, 2017 | © 2017 Glaukos Corporation iDose Travoprost US Phase II: Preliminary Efficacy Results Average percentage IOP reductions through Week 12 in implant arms ranging from 32% to 37% 37% 34% 33% 35% 33% 32% 30% 30% 31% 0% 5% 10% 15% 20% 25% 30% 35% 40% Week 2 Week 6 Week 12 n= iDose is not approved by the FDA. Percent IOP Reductions through Week 12* 51 54 49 51 54 49 51 54 49 Fast Elution Slow Elution Timolol 0.5% *Calculated using all IOP observations through each data point weighted equally
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Day | September 14, 2017 | © 2017 Glaukos Corporation iDose Travoprost US Phase II: Preliminary Efficacy Results Average IOP reductions at Months 6 and 9 ranging from 7.9 to 8.4 mm Hg 8.4 8.3 8.0 7.9 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 9.0 Month 6 Month 9 n=73 iDose is not approved by the FDA. Average IOP Reductions at Months 6 to 9* n=43 Fast Elution Slow Elution *Calculated using all IOP observations through each data point weighted equally
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Day | September 14, 2017 | © 2017 Glaukos Corporation iDose Travoprost US Phase II: Preliminary Efficacy Results Average IOP reductions through 9 months post-op ranging from 7.9 to 9.5 mm Hg 9.5 8.7 8.5 8.4 8.3 8.7 8.2 8.0 8.0 7.9 0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 10.0 Week 2 Week 6 Week 12 Month 6 Month 9 n=105 n=105 n=105 n=73 n=43 iDose is not approved by the FDA. Average IOP Reductions through Month 9* Fast Elution Slow Elution *Calculated using all IOP observations through each data point weighted equally
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Day | September 14, 2017 | © 2017 Glaukos Corporation iDose Travoprost US Phase II: Preliminary Efficacy Results Average percent IOP reductions through 9 months post-op in implant arms ranging from 32% to 37% 37% 34% 33% 33% 32% 35% 33% 32% 32% 32% 0% 5% 10% 15% 20% 25% 30% 35% 40% Week 2 Week 6 Week 12 Month 6 Month 9 n=73n=105n=105 iDose is not approved by the FDA. Percent IOP Reductions through Month 9* n=105 n=43 Fast Elution Slow Elution Timolol 0.5% *Calculated using all IOP observations through each data point weighted equally
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Day | September 14, 2017 | © 2017 Glaukos Corporation Intraoperative Adverse Events None reported (n=105) Blood Plasma Levels All implant samples below level of quantitation (BLQ) for travoprost iDose is not approved by the FDA. iDose Travoprost US Phase II: Preliminary Safety Data
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Day | September 14, 2017 | © 2017 Glaukos Corporation One report of iris hyperpigmentation No reports of hyperemia to date Hyperemia for prostaglandins often reported in the 30-50% range iDose is not approved by the FDA. Excellent safety profile demonstrated No serious adverse events reported Post-Op Adverse Events Reported > 1% All groups combined Totals n=154 Intraocular pressure increased Iritis Decreased BCVA > 2 lines vs baseline Dry eye Eye inflammation Eye pain Foreign body sensation in eyes Posterior vitreous detachment 4 (2.6%) 4 (2.6%) 4 (2.6%) 3 (1.9%) 3 (1.9%) 3 (1.9%) 2 (1.3%) 2 (1.3%) iDose Travoprost US Phase II: Preliminary Safety Data
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Day | September 14, 2017 | © 2017 Glaukos Corporation Travatan Z1 Adverse Events > 1% Package Insert Incidence Ocular hyperemia Decreased visual acuity Eye discomfort Foreign body sensation in eye Eye pain Eye pruritis Abnormal vision, blepharitis, blurred vision, cataracts, conjunctivitis, corneal staining, dry eye, iris discoloration, keratitis, lid margin crusting, ocular inflammation, photophobia, subconjunctival hemorrhage, tearing 30-50% 5-10% 5-10% 5-10% 5-10% 5-10% 1-4% 1 US Package Insert, Travatan Z. 2 US Package Insert, Lumigan Lumigan 0.01%2 Adverse Events Package Insert Incidence Conjunctival edema, conjunctival hemorrhage, eye irritation, eye pain, eye pruritis, erythema of eyelid, eyelid pruritis, growth of eyelashes, hypertrichosis, instillation site irritation, punctate keratitis, skin hyperpigmentation, vision blurred, visual acuity decreased 31% 1-4% Conjunctival hypermia Safety Data Reported for Topical Hypotensive Agents for Glaucoma
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Day | September 14, 2017 | © 2017 Glaukos Corporation 1.Martin KR, Lewis RA, Christie WC, et al. Interim 12 month Efficacy, Safety, and Patient Reported Outcomes in a Phase I/II trial of Bimatoprost SR Implants for Glaucoma Therapy, WGC poster, Helsinki, Finland, 2017 2.Serle J, Lewis RA, Kopczynski C, Heah T. Fixed Combination Netarsudil 0.02%/Latanoprost 0.005% vs. Netarsudil or Latanoprost in Glaucoma Patients, WGC poster, Helsinki, Finland, 2017 Bimatoprost SR , Netarsudil, and Netarsudil/Latanoprost are unapproved drugs and limited by US law to investigational use Recent Safety Data Reported for Investigational Hypotensive Agents for Glaucoma Bimatoprost SR1 Post-Op Adverse Events Reported > 5% Totals n=75 Conjunctival hyperemia Foreign body sensation in eye Eye pain Lacrimation increased Conjunctival hemorrhage Punctate keratitis Photophobia 21 (28.0%) 12 (16.1%) 11 (14.7%) 10 (13.3%) 9 (12.0%) 8 (10.7%) 8 (10.7%) Vision blurred Increased IOP 7 (9.3%) 6 (8.0%) Netarsudil/Latanoprost and Netarsudil2 Post-Op Adverse Events Reported > 5% Netarsudil 0.02%/ Latanoprost n=238 Conjunctival hyperemia Instillation site pain Conjunctival hemorrhage Eye pruritis Lacrimation increased Cornea verticillata 127 (53.4%) 46 (19.3%) 25 (10.5%) 18 (7.6%) 14 (5.9%) 12 (5.0%) Netarsudil 0.02% n=244 100 (41.0%) 51 (20.9%) 34 (13.9%) 17 (7.0%) 15 (6.1%) 10 (4.1%)
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Day | September 14, 2017 | © 2017 Glaukos Corporation iDose Travoprost US Phase II: Summary and Next Steps Efficacy • Initial efficacy demonstrated through 12-week endpoint • To date, continued efficacy of ~30% IOP reduction from baseline demonstrated through 9 months post-op • Both implant arms promising with 7-8 mm Hg IOP reductions from baseline Safety • No intraoperative adverse events reported • Favorable post-op safety profile, no serious adverse events reported • No systemic blood levels of travoprost detected US Phase II Preliminary Results Next Steps End of Phase II meeting with FDA to be scheduled for Q4 2017 • Discussion of Phase II results and review of Phase III plans Expectation is to move forward with two 600+ subject Phase III trials in 2018 • One trial to be primarily in US/Americas sites • The other trial to be at sites primarily in Europe/Asia iDose is not approved by the FDA.
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Day | September 14, 2017 | © 2017 Glaukos Corporation Decades-long industry efforts to address non-adherence with sustained-release glaucoma therapies have achieved limited success to date External approaches have been limited by duration of effect due to API loading, inefficient drug delivery pathways and patient retention/tolerance issues Bimatoprost SR is nearest intraocular approach to iDose Travoprost Product (Company) Description Development Stage Duration Bimatoprost SR (Allergan) Biodegradable implant Phase I/II Designed to release drug for 6 months Topical Bimatoprost Ocular Insert (Allergan) Peri-ocular ring Phase I/II Designed to elute drug for up to 6 months OTX-TP (Ocular Therapeutix) Punctal plug Phase III Designed for 90 days of active drug delivery Evolute (Mati Therapeutics) Punctal plug Phase II Designed to deliver drug for 3 months Travoprost Extended Release (Envisia Therapeutics) Biodegradable implant Phase II Designed to deliver drug for 6-12 months Ocular Hypotensive Sustained-Release Landscape
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Day | September 14, 2017 | © 2017 Glaukos Corporation MIGS Glaukos Surgical
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Day | September 14, 2017 | © 2017 Glaukos Corporation Injectable 2-stent therapy for standalone procedures Injectable 2-stent therapy for combo- cataract procedures Portfolio of Micro-Scale Injectable Therapy REFRACTORYADVANCEDMODERATEMILD OCULAR HYPERTENSION Single stent therapy for combo-cataract procedures OAG Progression OCULAR HYPERTENSION MILD MODERATEADVANCED REFRACTORY iStent Inject and iStent SA are not approved by the FDA.
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Day | September 14, 2017 | © 2017 Glaukos Corporation Current US Combination-Cataract and Future Standalone Market Combination Cataract Standalone Estimate the current US combination cataract MIGS market to be roughly 1/10th the size of the potential standalone MIGS market
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Day | September 14, 2017 | © 2017 Glaukos Corporation 0.4 mm 0.3 mm dia. Two heparin-coated titanium trabecular bypass stents preloaded into auto injection system Provides enhanced procedural ease with ability to enter the eye once to implant both stents in straightforward click-and- release motion Multiple stent placement designed to increase access to more collector channels Initial indication in combination with cataract creates revenue to drive pipeline and platform development Combination-Cataract Therapy for Mild to Moderate OAG OAG Progression OCULAR HYPERTENSION MILD MODERATEADVANCED REFRACTORY iStent Inject is not approved by the FDA.
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Day | September 14, 2017 | © 2017 Glaukos Corporation Combination-Cataract Therapy for Mild to Moderate OAG iStent Inject is not approved by the FDA.
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Day | September 14, 2017 | © 2017 Glaukos Corporation iStent inject: Combination-Cataract Therapy for Mild to Moderate OAG US Regulatory Status Enrollment and 2-year follow-up in 500-patient pivotal trial complete Expect to file full PMA by YE 2017; estimated FDA approval in 2H 2018 OUS Regulatory Status Currently available in multiple international markets (with additional indication for standalone procedures) iStent Inject is not approved by the FDA.
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Day | September 14, 2017 | © 2017 Glaukos Corporation 2 iStents + Cataract Comparative Case Series (n=28) 2.8 1.7 1.2 1.2 1.0 17.3 13.4 13.3 13.5 13.8 0 4 8 12 16 20 0 1 2 3 4 5 6 Preop Month 3 Month 6 Month 9 Month 12 Mean # of medsMean IOP mmHg Mean#ofmeds Belovay G et al Journal of Cataract and Refractive Surgery 2012 Clinical Performance of 2 iStents with Cataract Surgery All subjects had IOP not well controlled on medication or well controlled with substantial (≥ 3) medication burden Stent implantation conducted in conjunction with cataract surgery Mean IOP declined 20% to 13.8 mm Hg at 12 months Mean number of meds declined 64% to 1.0 at 12 months Reduction in mean # of meds 64%
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Day | September 14, 2017 | © 2017 Glaukos Corporation Injectable 2-stent therapy for standalone procedures Injectable 2-stent therapy for combo- cataract procedures Portfolio of Micro-Scale Injectable Therapy REFRACTORYADVANCEDMODERATEMILD OCULAR HYPERTENSION Single stent therapy for combo-cataract procedures OAG Progression OCULAR HYPERTENSION MILD MODERATEADVANCED REFRACTORY iStent Inject and iStent SA are not approved by the FDA.
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Day | September 14, 2017 | © 2017 Glaukos Corporation 0.4 mm 0.4 mm Flow outlets (x4)Central Outlet Central Inlet Two heparin-coated titanium stents, preloaded into auto injection system Tapered insertion sleeve yields smooth insertion during closed- chamber procedure Ability to enter the eye once to implant both stents in straightforward click-and-release motion Standalone 2-Stent Therapy for Mild to Moderate OAG OAG Progression OCULAR HYPERTENSION MILD MODERATEADVANCED REFRACTORY iStent SA is not approved by the FDA.
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Day | September 14, 2017 | © 2017 Glaukos Corporation Facile, Closed-Chamber, Click-and-Release 2-Stent Procedure iStent SA is not approved by the FDA.
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Day | September 14, 2017 | © 2017 Glaukos Corporation iStent SA: Standalone 2-Stent Therapy for Mild to Moderate OAG IDE Initial Trial 75 phakic and pseudophakic OAG patients randomized to receive stents or SLT Narrow inclusion/exclusion criteria Enrollment required 2+ years Regulatory Strategy Potential to broaden inclusion criteria by evaluating only pseudophakic OAG Goal is for timely entry into US market with standalone indication In active discussion with FDA for expansion phase protocol approval Australian HTA Draft Algorithm
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Day | September 14, 2017 | © 2017 Glaukos Corporation 15.9 14.1 12.2 10 14 18 22 26 Mean preop medicated IOP Mean preop IOP after washout Month 18 mean IOP without medication 1 Stent 2 Stent 3 Stent mmHg Mean IOP at 18 Months without Glaucoma Medication Titratable Therapy with Injectable Trabecular Bypass Stents International study of OAG patients (n=119) with unmedicated IOP of 22-38 mm Hg Patients randomized to receive 1, 2 or 3 stents in standalone procedure; follow-up to continue for 5 years Safety data similar across all stent groups Katz LJ et al Clinical Ophthalmology
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Day | September 14, 2017 | © 2017 Glaukos Corporation mmHg 19.5 24.4 14.3 14.6 14.2 14.4 14.1 10 14 18 22 26 Preop Baseline (Washout) Month 1 Month 6 Month 12 Month 18 Month 24 Lindstrom R ASCRS 2017 2 Standalone Stents* Mean IOP Clinical Results of 2 iStents in a Standalone Procedure International, prospective study All patients (n=57) on 1 preoperative glaucoma medication At 24 months, 98% achieved ≥ 20% reduction in unmedicated IOP vs baseline washout IOP Favorable safety profile Lindstrom R ASCRS 2017 * iStent inject
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Day | September 14, 2017 | © 2017 Glaukos Corporation OAG Progression OCULAR HYPERTENSION MILD MODERATEADVANCED REFRACTORY Accesses secondary outflow pathway; envision use primarily in combination with other MIGS devices Portfolio of Micro-Scale Injectable Therapy REFRACTORYADVANCEDMODERATEMILD OCULAR HYPERTENSION iStent Supra is not approved by the FDA.
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Day | September 14, 2017 | © 2017 Glaukos Corporation Titanium Sleeve Retention Features Outlet Inlet OAG Progression OCULAR HYPERTENSION MILD MODERATEADVANCED REFRACTORY 4 mm implant, curved to follow ocular anatomy Lumen sized for optimal flow and minimal trauma Heparin-coated inter-lumen designed to aid flow Outlet location optimized to maximize flow with minimal encapsulation potential Suprachoroidal Stent Accesses Secondary Outflow Pathway iStent Supra is not approved by the FDA.
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Day | September 14, 2017 | © 2017 Glaukos Corporation iStent SUPRA: Accessing the Suprachoroidal Space Clinical Profile Accesses secondary outflow pathway; large theoretical resorptive area for drainage Based on century-old cyclodialysis cleft procedure Clinical efficacy appears similar to a single iStent in combination with cataract surgery Lack of governing back- pressure may contribute to more variable IOP Often associated with higher risks that trabecular stents Optimal Use Enhancement to trabecular stents in progressive cases where lower IOP targets are desired Regulatory Status Enrollment of 505-patient pivotal trial complete; 2-year follow-up projected for early 2019 Full PMA filing to FDA by 2H 2019 iStent Supra is not approved by the FDA.
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Day | September 14, 2017 | © 2017 Glaukos Corporation Injectable 3-stent therapy for standalone procedures REFRACTORYADVANCEDMODERATEMILD OCULAR HYPERTENSION Portfolio of Micro-Scale Injectable Therapy OAG Progression OCULAR HYPERTENSION MILD MODERATEADVANCED REFRACTORY iStent infinite is not approved by the FDA.
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Day | September 14, 2017 | © 2017 Glaukos Corporation 0.4 mm 0.4 mm MIGS Solution for Advanced and Refractory OAG Three heparin-coated trabecular bypass stents, identical to iStent SA Enhanced insertion system provides unlimited activations and smooth implantation of each stent across 5-6 clock hours of Schlemm’s canal Less invasive, faster recovery and fewer complications than conventional late-stage procedures No bleb formation OAG Progression OCULAR HYPERTENSION MILD MODERATEADVANCED REFRACTORY iStent infinite is not approved by the FDA.
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Day | September 14, 2017 | © 2017 Glaukos Corporation MIGS Solution for Advanced and Refractory OAG iStent infinite is not approved by the FDA.
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Day | September 14, 2017 | © 2017 Glaukos Corporation 15.9 14.1 12.2 10 14 18 22 26 Mean preop medicated IOP Mean preop IOP after washout Month 18 mean IOP without medication 1 Stent 2 Stent 3 Stent mmHg Mean IOP at 18 Months without Glaucoma Medication Titratable Therapy with Injectable Trabecular Bypass Stents Katz LJ et al Clinical Ophthalmology International study of OAG patients (n=119) with unmedicated IOP of 22-38 mm Hg Patients randomized to receive 1, 2 or 3 stents in standalone procedure; follow-up to continue for 5 years Safety data similar across all stent groups
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Day | September 14, 2017 | © 2017 Glaukos Corporation 0.37 0.43 28.42 14.17 14.73 13.42 13.68 0 5 10 15 20 25 30 0 0.5 1 1.5 2 Baseline Month 1 Month 3 Month 6 Month 12 1.83 Mean # of medsMean IOP mmHg Mean#ofmeds 3 iStents in Standalone Surgery Single-Site Case Series (n=30) Early Clinical Performance of 3-Stent Solution All patients had prior glaucoma surgery, including 27 trabeculectomies Mean IOP declined 52% to 13.68 mm Hg at 12 months Mean number of meds declined 77% to 0.43 at 12 months
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Day | September 14, 2017 | © 2017 Glaukos Corporation iStent infinite Refractory Clinical Trial Clinical protocol to follow ANSI guidance Standalone procedure in phakic and pseudophakic refractory OAG patients Will propose inclusion of POAG, PEX and PDS patients uncontrolled either after failed incisional surgeries or by maximal medical therapy Only 65 subjects required so that > 50 available at 12-month endpoint Comparison to historical predicate device IDE clinical study followed by 510(k) submission Q4 2017 IDE filing with estimated 2020- 2021 FDA clearance Proposal for n=65, followed for 1 year
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Day | September 14, 2017 | © 2017 Glaukos Corporation Optimizing MIGS Performance
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Day | September 14, 2017 | © 2017 Glaukos Corporation Intelligent Placement of Trabecular Stents Optimizing Stent Placement Collector channels and aqueous veins are not distributed uniformly around the limbus Targeting collector channels may further improve current favorable efficacy profile of trabecular stents
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Day | September 14, 2017 | © 2017 Glaukos Corporation Intelligent Placement of Trabecular Bypass Stents
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Day | September 14, 2017 | © 2017 Glaukos Corporation MIGS AND BEYOND Combining Novel Technologies
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Day | September 14, 2017 | © 2017 Glaukos Corporation Number of Medications by % of Patients (US) 1 Med 48% 2 Meds 28% ≥3 Meds 24% Combination Glaucoma Therapy: A Factual Review Market Scope Combination Medication Therapy Widely used to increase outflow and/or reduce production of aqueous humor Restoring 100% aqueous humor outflow through both the conventional and uveoscleral pathways is an ideal dual mechanism High rates of patient non- adherence and other factors limit effectiveness of topical medications First-Line Therapy by Drug Class (US) Prostaglandins Beta Blockers Alpha Agonists Combination Drugs Other 53% 13% 10% 16% 8%
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Day | September 14, 2017 | © 2017 Glaukos Corporation Trabecular Bypass Drug Delivery Trabecular Bypass Mild to Moderate Refractory MIGS Combination Glaucoma Therapy Combination MIGS Therapy Multiple combinations capable of restoring outflow through both the conventional and uveoscleral pathways Expect iStent SA (or iStent infinite) and iDose Travoprost to ultimately be combination of choice
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Day | September 14, 2017 | © 2017 Glaukos Corporation mmHg 19.7 24.9 13.0 12.9 12.7 12.4 16.6 12.9 10 15 20 25 30 Preop Baseline M1 M3 M6 M12 M13 M18 (After med washout) (After med washout) OAG subjects on 2 medications pre-op received 2 iStent inject stents and 1 post-op medication Clinical Results Show Benefit of Combination Therapy Berdahl J et al Clinical & Experimental Ophthalmology 2017 2 Stents + Topical Travoprost Mean IOP Over Time (n=53) Drug Delivery Trabecular Bypass Trabecular Bypass
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Day | September 14, 2017 | © 2017 Glaukos Corporation 22.2 25.3 14.0 13.8 13.2 13.0 17.1 11.8 10 15 20 25 30 SCR BL M1 M3 M6 M12 M13 M18 mmHg (After med washout) (After med washout) Clinical Results Show Benefit of Combination Therapy Ahmed I et al Journal of Cataract & Refractive Surgery 2014 OAG subjects not controlled on 2 medications pre-op received 2 stents and 1 post-op prostaglandin 2 Stents + Topical Travoprost Mean IOP Over Time (n=39) Drug Delivery Trabecular Bypass Trabecular Bypass
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Day | September 14, 2017 | © 2017 Glaukos Corporation Portfolio of Micro-Scale Injectable Therapy: Beyond 2020 REFRACTORYADVANCEDMODERATEMILD OCULAR HYPERTENSION Combination Therapy + / Expect combination therapy to emerge first among pseudophakic OAG patients, followed by phakic OAG patientsiStent Inject, iStent SA, iStent infinite are not approved by the FDA. Drug Delivery Trabecular Bypass Trabecular Bypass
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Day | September 14, 2017 | © 2017 Glaukos Corporation Portfolio of Micro-Scale Injectable Therapy: First-Line Therapy Beyond 2020 REFRACTORYADVANCEDMODERATEMILD OCULAR HYPERTENSION Bifurcated market for mild OAG Expect iStent SA to be used primarily in previously medicated patients, with some surgeons preferring restoration of natural outflow as first-line therapy Drugs remain predominant first-line therapy Many ophthalmologists are drugophiles; expect indication, duration and payor coverage to drive iDose utilization Jump balls Expect iDose or iStent SA use in mild OAG, with combination therapy used increasingly in moderate, advanced and refractory OAGiStent Inject, iStent SA and iDose are not approved by the FDA. Drug Delivery Trabecular Bypass Trabecular Bypass
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Day | September 14, 2017 | © 2017 Glaukos Corporation Portfolio of Micro-Scale Injectable Therapy: Enhancement Beyond 2020 REFRACTORYADVANCEDMODERATEMILD OCULAR HYPERTENSION iStent Inject, iStent SA and iDose are not approved by the FDA. Drug Delivery Trabecular Bypass Trabecular Bypass
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Day | September 14, 2017 | © 2017 Glaukos Corporation Panel Discussion – Glaukos Solutions Portfolio Glaukos Management Tom Burns, President & CEO Dave Haffner, SVP New Technologies Hal Heitzmann PhD, SVP Applied Research & Engineering Jeff Wells PharmD, SVP Regulatory, Quality & Clinical Affairs Guest Surgeons Eric Donnenfeld MD John Berdahl MD
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Day | September 14, 2017 | © 2017 Glaukos Corporation 20-Minute Coffee Break
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Day | September 14, 2017 | © 2017 Glaukos Corporation Our Market Opportunity
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Day | September 14, 2017 | © 2017 Glaukos Corporation Combine the latest glaucoma epidemiology, actual claims data and market research to outline the addressable market opportunity across the entire Glaukos product portfolio OBJECTIVE Understanding Our Market Opportunity
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Day | September 14, 2017 | © 2017 Glaukos Corporation Glaukos Opportunity • Prevalence rate • Diagnosed & treated rate • Disease stage/severity Glaucoma Suspects Ocular Hypertension Primary OAG Other Glaucoma Understanding the US Glaucoma Market Opportunity • Age, ethnicity, genetics • 5-10M people in US • Elevated IOP • No visual field loss or optic nerve damage detected • Elevated IOP • Visual field loss and optic nerve damage detected • Primary closed-angle glaucoma • Secondary/other • Lifetime disease progression • Expected treatment algorithm across Glaukos portfolio
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Day | September 14, 2017 | © 2017 Glaukos Corporation Status Quo • Numerous population-based surveys and studies • Since 1960s, studies have progressively shown higher POAG/OHT prevalence rates each decade Historical view of POAG and OHT Prevalence Historical survey- based population studies have shortcomings Shortcomings • Shift from surveys to detailed ocular exams in studies; wide criteria variation • Largely caucasian population (< 60% of US population; lower prevalence rates) • > 30% ganglion cell loss from visual field test required to detect • Advancements in visual field and IOP measurement tools; limit utility of historical studies
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Day | September 14, 2017 | © 2017 Glaukos Corporation Assessing Market Opportunity with Objective Data We believe prevalence to be larger than previously estimated P O AG & O H T Market Scope Medicare Claims Data Physician Surveys Cataract Surgery Data IMS Health Compliance Studies Glaucoma Rx Data Medicare & Commercial Claims Data POAG & OHT Medical Claims Data
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Day | September 14, 2017 | © 2017 Glaukos Corporation Glaucoma Rx Implied POAG Prevalence P O A G & O H T Glaucoma Rx Data % of patients that don’t refill 2nd Rx 10-25% “Compliant” patient rate of compliance 70-75% Implied overall annual Rx usage rate 40-55% Implied 2017 POAG Prevalence ~4.1M – 8.3M people % of patients on meds at end of year 1 40-60% Medication mix rates Diagnosis ratesActual Rx units
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Day | September 14, 2017 | © 2017 Glaukos Corporation P O A G & O H T Cataract Surgery Data Cataract Surgery Implied POAG Prevalence • Medicare claims analysis • External consultants analysis • Market Scope physician surveys Implied 2017 POAG Prevalence ~5.8M – 8.0M people Cataract & POAG/OHT Co-morbidity 15-20% Olmstead Eye Study age distribution POAG & OHT prevalence rates by age Market Scope cataract surgery forecast
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Day | September 14, 2017 | © 2017 Glaukos Corporation Implied 2017 POAG Prevalence ~5.4M people Glaucoma vs OHT upcoding adjustment Uninsured population adjustment Remove other glaucoma P O A G & O H T POAG & OHT Medical Claims Data Medical Claims Data Implied POAG Prevalence Commercial insurance glaucoma claims by age* 10.4M covered lives * Required 2 separate glaucoma claims >30 days apart
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Day | September 14, 2017 | © 2017 Glaukos Corporation Historical Population-Based Surveys P O A G & O H T Cataract Surgery Data Glaucoma Rx Data POAG & OHT Medical Claims Data Putting It All Together: 2017 US POAG Prevalence Cataract Surgery Data Glaucoma Rx Data Medical Claims Data Glaukos Estimate ~5.4M ~4.2M ~6-8M ~4-8M ~5.4M
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Day | September 14, 2017 | © 2017 Glaukos Corporation P O A G & O H T Cataract Surgery Data Glaucoma Rx Data POAG & OHT Medical Claims Data Putting It All Together: 2017 US POAG Prevalence Glaukos Estimated US POAG Prevalence ~5.4M people ~ 10M POAG & OHT individuals* ~ 18M POAG & OHT eyes* * Based on 0.85 ratio of OHT to POAG; bilateral rate of glaucoma of 1.8
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Day | September 14, 2017 | © 2017 Glaukos Corporation 8.3M eyes 9.8M eyes 2017 POAG and OHT Prevalence by Disease Stage/Severity REFRACTORYADVANCEDMODERATEMILD OCULAR HYPERTENSION 52% 5.1m eyes 25% 2.4m eyes 14% 1.3m eyes 9% 950k eyes 33%Pseudophakicprevalence Physician discussions and medication burden to estimate disease stage/severity prevalence Pseudophakic population based on historic cataract surgery and mortality statistics
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Day | September 14, 2017 | © 2017 Glaukos Corporation Prevalence Annual new population Translating Prevalence into Annual Market Opportunity S TA G E 1 REFRACTORYADVANCEDMODERATEMILD OCULAR HYPERTENSION S TA G E 2 S TA G E 3 S TA G E 4 S TA G E 5 ~18M POAG/OHT eyes > ~8.2M diagnosed and treated eyes Size of the underlying market by disease stage, diagnosis and treatment rates Disease progression drives re-treatment/enhancement rates Death / blindness Diagnosed and Treated Undiagnosed or untreated Disease progression 1.7M eyes 6.5M eyes
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Day | September 14, 2017 | © 2017 Glaukos Corporation Translating Prevalence into Annual Market Opportunity (cont’d) REFRACTORYADVANCEDMODERATEMILD OCULAR HYPERTENSION Glaukos product of choice, monotherapy or in combination, across the disease stages Monotherapy Combination therapy
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Day | September 14, 2017 | © 2017 Glaukos Corporation 2017 Annual Market Opportunity By Product: Combination Cataract Combination Cataract Eyes (000s) 0 100 200 300 400 500 600 700 800 900 Annual Co-Morbidity 600 800 Combo-cataract = annual opportunity iStent Inject and iStent Supra are not approved by the FDA.
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Day | September 14, 2017 | © 2017 Glaukos Corporation Recurring annual therapy utilized across disease stage continuum Diagnosed and treated market prevalence = annual opportunity Glaukos monotherapy / combination therapy algorithm applied 2017 Annual Market Opportunity By Product: Standalone 1 2Pseudo Eyes Phakic Eyes Total dx & treated opportunity: ~6M eyes Total prevalence opportunity: ~14.5M eyes Topical Rx intolerant Non-compliant Rx patients Other Rx AEs Failing on Rx Other dx & treated patients 175k 550k 425k 175k 650k 375k 1,125k 875k 375k 1,300k iDose is not approved by the FDA.
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Day | September 14, 2017 | © 2017 Glaukos Corporation 2017 Market Opportunity By Product: Standalone Standalone procedure = diagnosed and treated population Glaukos monotherapy / combination therapy algorithm applied Progression / enhancement opp: ~3.1M POAG & OHT eyes* are 5yrs older per year 1 2Pseudo Eyes Phakic Eyes Total dx & treated opportunity: ~2.7M eyes Total prevalence opportunity: ~4.4M eyes Topical Rx intolerant Non-compliant Rx patients Other Rx AEs Other dx & treated patients 100k 325k 200k 250k 175k 600k 425k 575k *Over age 65 iStent SA is not approved by the FDA.
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Day | September 14, 2017 | © 2017 Glaukos Corporation 800 Failing on Rx - Prevalence Remaining diagnosed & treated eyes 2017 Annual Market Opportunity By Product: Standalone Annual late stage procedures (000s) Total dx & treated opportunity: ~1.6M eyes Total prevalence opportunity: ~2.0M eyes Tubes/Trabs, etc. = annual opportunity Standalone procedure = diagnosed and treated population Glaukos monotherapy / combination therapy algorithm applied 0 20 40 60 80 100 120 140 Annual Tubes/Trabs 125 All eyes (pseudo/phakic) (000s) 775 iStent infinite is not approved by the FDA.
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Day | September 14, 2017 | © 2017 Glaukos Corporation Prevalence Growth Population growth and aging Ethnic mix shift 9.8 11.2 8.3 9.5 0 5 10 15 20 25 2017 2022 18.1M 20.7M 1 Over age 40; 3.6% over age 65 POAG and OHT Prevalence (MM Eyes) OHTPOAG ~3%Annual Growth1
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Day | September 14, 2017 | © 2017 Glaukos Corporation 6.5 7.8 1.7 2.0 0 2 4 6 8 10 12 2017 2022 8.2M 9.8M Diagnosed and Treated Growth Improved diagnosis rates driven by technology, available solutions and access to heath care 1 Over age 40; 4.4% over age 65 Dx and Treated Population (MM Eyes) OHTPOAG ~3.6%Annual Growth1
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Day | September 14, 2017 | © 2017 Glaukos Corporation Our Global Commercialization
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Day | September 14, 2017 | © 2017 Glaukos Corporation Expanding our Global Footprint iStent products are currently approved for use in 30+ countries Current & planned regional sales HQ Distributor marketsDirect markets (14)
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Day | September 14, 2017 | © 2017 Glaukos Corporation Americas In combination with cataract surgery In standalone procedures Direct Sales Established Products Reimbursement Status Commercialization Status Brazil US Canada 2017 2016 2012 iStent iStent inject iStent iStent inject iStent Varying coverage from private and public payors Efforts underway to secure national coverage Full Medicare and national commercial payor coverage established • Surgeon training in early stages • Hub for distributors in other Latin American countries Reimbursement and coverage varies by Province Largest US MIGS sales organization
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Day | September 14, 2017 | © 2017 Glaukos Corporation Cataract & Comprehensive Ophthalmic Surgeons Diagnose and monitor glaucoma; prescribe meds and perform glaucoma laser and MIGS procedures Perform invasive surgeries, including trabeculectomies and tube shunts (~125K/year) Focus on achieving lowest target pressures to treat OAG; higher tolerance for adverse events Glaucoma Specialists US Ophthalmic Physician Community Market Socpe; excludes refractive only surgeons, retinal specialists, general ophthalmologists and other unrelated subspecialties Primarily perform cataract and refractive procedures Often also diagnose and monitor glaucoma; prescribe meds and perform MIGS and glaucoma laser procedures Focus on uneventful procedures that provide best corrected visual acuity and rapid visual rehabilitation; low tolerance for adverse events ~7,700 ~1,200
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Day | September 14, 2017 | © 2017 Glaukos Corporation Europe In combination with cataract surgery In standalone procedures Direct Sales Established Products Reimbursement Status Commercialization Status France Ireland Germany 2017 2014 2017 iStent iStent inject • Typically government-funded healthcare • Current iStent and/or iStent inject coverage varies by country • NICE recently recognized iStent with highest possible rating • Efforts underway to ensure adequate iStent and/or iStent inject reimbursement in all direct markets Netherlands Spain Sweden Switzerland UK 2017 2017 2017 2017 2017 Surgeon training in early stages in newest markets
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Day | September 14, 2017 | © 2017 Glaukos Corporation In combination with cataract surgery Asia Pacific In standalone procedures Direct Sales Established Products Reimbursement Status Commercialization Status Australia Singapore Japan 2016 2016 2017 iStent iStent inject iStent iStent Interim facility code in place while application is under review Coverage established by MHLW at YE 2016 Efforts to secure coverage underway Largest MIGS sales organization in Australia JGS-approved “koshykai” training (245 participating surgeons) Surgeon training in early stages
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Day | September 14, 2017 | © 2017 Glaukos Corporation Alcon CyPass • 6.35 mm polyimide shunt implanted ab interno into suprachoroidal space • Approved by FDA in 2016 for combo-cataract procedures Ivantis Hydrus • 8 mm nitinol device implanted ab interno into Schlemm’s canal • Under FDA investigation for combo-cataract procedures; not currently approved • Manual rotary insertion XEN Competitive Surgical Landscape Mild to Moderate Refractory Allergan XEN • 6 mm collagen shunt implanted ab interno into subconjunctival space • Creates bleb; requires use of antimetabolite • Approved by FDA in 2016 for combo-cataract or standalone procedures iStentiStent Inject CyPass HydrusXENiStent Supra
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Day | September 14, 2017 | © 2017 Glaukos Corporation Competitive Surgical Landscape iStent is approx. 1/48th the size of CyPass Two iStent inject stents are approx. 1/73rd the size of CyPass iStent inject CyPass iStent CyPass iStent and iStent inject are designed to be as large as required by fluid dynamics – and not larger Hunter KS, Fjield T, Heitzmann H, Shandas R, Kahook MY. Characterization of micro-invasive trabecular bypass stents by ex vivo perfusion and computational flow modeling. Clinical Ophthalmology (Auckland, NZ). 2014;8:499-506.
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Day | September 14, 2017 | © 2017 Glaukos Corporation Single iStentCyPass Single iStentCyPass Mean IOP Mean # Medications iStent and CyPass Pivotal Trials: Year 1 Mean IOP and Meds 18.4 24.4 16.7 18.7 25.4 17.0 10.0 12.0 14.0 16.0 18.0 20.0 22.0 24.0 26.0 28.0 Screening IOP Washout IOP 12 Month IOP MeanIOP(mmHg) 1.4 0.2 1.6 0.2 0 1 2 3 Mean#Medications Screening # Meds 12 Month # Meds Samuelson TW, Katz LJ, Wells JM, Duh Y-J, Giamporcaro JE. Ophthalmology 2011;118:459-467. Craven ER, Katz LJ, Wells JM, Giamporcaro JE. J Cataract Refract Surg 2012;38:1339-1345. Vold S, Ahmed I, Craven R, Mattox C. Ophthalmology 2016;123:2103-2112.
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Day | September 14, 2017 | © 2017 Glaukos Corporation 18.4 24.4 17.0 18.7 25.4 17.1 10.0 12.0 14.0 16.0 18.0 20.0 22.0 24.0 26.0 28.0 Screening IOP Washout IOP 24 Month IOP Mean IOP MeanIOP(mmHg) 1.4 0.2 1.6 0.3 0 1 2 3 Mean # Medications Mean#Medications Screening # Meds 24 Month # Meds iStent and CyPass Pivotal Trials: Year 2 Mean IOP and Meds Single iStentCyPass Single iStentCyPass Samuelson TW, Katz LJ, Wells JM, Duh Y-J, Giamporcaro JE. Ophthalmology 2011;118:459-467. Craven ER, Katz LJ, Wells JM, Giamporcaro JE. J Cataract Refract Surg 2012;38:1339-1345. Vold S, Ahmed I, Craven R, Mattox C. Ophthalmology 2016;123:2103-2112.
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Day | September 14, 2017 | © 2017 Glaukos Corporation PLATFORM DEVELOPMENT Delivering Novel Surgical & Pharmaceutical Glaucoma Therapy
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Day | September 14, 2017 | © 2017 Glaukos Corporation Restoring natural, physiological outflow Portfolio of micro-scale flow devices for full range of glaucoma severity and progression IOP diagnostics and management Goal to provide micro-scale implantable tools for monitoring and managing IOP Flow Devices MEMS Biosensors Drug Delivery Platform Pillars of Hybrid Pharma/Device Leader Sustained drug delivery Goal to deliver additional glaucoma drugs and expand into other ophthalmic diseases
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Day | September 14, 2017 | © 2017 Glaukos Corporation • MIGS pioneer with unrivaled portfolio of micro-scale glaucoma devices • Breakthrough ab interno surgical innovation • Deep experience and demonstrated track record in micro-engineering design, assembly and manufacturability • Regulatory strategy and market positioning focused on large patient populations iStent & iStent inject iStent SA iStent infinite iStent SUPRA Platform Pillars: Flow Devices Flow Devices Restoring natural, physiological outflow Portfolio of micro-scale flow devices for full range of glaucoma severity and progression
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Day | September 14, 2017 | © 2017 Glaukos Corporation iDose Travoprost • Leveraging unique expertise in micro-mechanical design, assembly and filling processes • Building seasoned ocular drug delivery team of chemists, scientists and engineers • Understanding necessary drug characteristics and predictability for delivery via iDose system • Optimizing iDose system design and characterization to achieve critical quality attributes Platform Pillars: Drug Delivery Sustained drug delivery Goal to deliver additional glaucoma drugs and expand into other ophthalmic diseases Drug Delivery
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Day | September 14, 2017 | © 2017 Glaukos Corporation Focused Development Program Recognized drawbacks with existing topical glaucoma treatments and extent of patient non- adherence to topical medications Engineering/Biologic Perseverance Overcame significant challenges of micro- scale prototype development, Fickian diffusion elution, longer-term stability and unknown biological mechanisms Manufacturing Processes Mastered art of predictably filling micro- scale devices, capping and terminally sterilizing iDose implant to provide scale-up production yields Favorable iDose Data Initial efficacy demonstrated through 12-week endpoint; continued efficacy of ~30% IOP reduction from baseline demonstrated through 9 months post-op; favorable safety profile Hybrid Pharma/Device Company Recognized role of drug delivery platforms and MIGS platforms to manage full range of glaucoma severity Built deep pipeline focused on injectable therapies and broad patient populations 2010 Strategic Regulatory Execution Secured favorable pivotal protocol and expedited IND Began Phase II study ahead of schedule 2011-Current 2015 2016 2017 2017+ Beyond MIGS: Building the Sustained Delivery Market
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Day | September 14, 2017 | © 2017 Glaukos Corporation VP, Translational Sciences PhD in chemistry with 20 years experience at Allergan, Pfizer and 3M Leads team with responsibilities including bioassay development, biocompatibility, toxicology, animal studies 30+Professionals currently comprise Glaukos Pharmaceuticals R&D organization, with prior experience at leading pharmaceutical companies Expanding Organizational Capability VP, Drug Delivery Innovation PhD in industrial and physical pharmacy with 20 years experience at Allergan Leads team with responsibilities including new formulation development, drug evaluation, new platform development and academic/private research Senior-Level Pharmaceutical Team VP, Applied Research 35 years relevant experience, including 10 years at Glaukos, working on flow and drug delivery innovations Leads team with responsibilities including formulation development, materials qualification, analytical method development, API sourcing, testing
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Day | September 14, 2017 | © 2017 Glaukos Corporation Chief Medical Officer Among Foremost US Glaucoma Experts Chief Medical Officer L. Jay Katz, MD, FACS Completed glaucoma fellowship at Wills Eye Hospital in Philadelphia in 1985 and affiliated with the hospital since that time, currently serving as its director of glaucoma service. Also serves as a professor of ophthalmology at Jefferson Medical College at Thomas Jefferson University. Former member of the board and past treasurer of the American Glaucoma Society and a diplomate and associate examiner for the American Board of Ophthalmology Published more than 200 articles in ophthalmic journals and served as an investigator in landmark glaucoma trials, including the Advanced Glaucoma Intervention Study (AGIS) and Collaborative Initial Glaucoma Treatment Study (CIGTS).
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Day | September 14, 2017 | © 2017 Glaukos Corporation State-of-the-Art High-Performance LC-MS Equipment Vertical Production Capabilities Automatic Filling Capping Assembly Tray Sealing Packaging Expanding Organization Capability
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Day | September 14, 2017 | © 2017 Glaukos Corporation Scope of Opportunity Beyond iDose Travoprost 01 The unique iDose platform Miniature reservoir contains drug formulation Scleral fixation protects against endothelial cell contact Hydrophobic membrane regulates drug release Ultra-precision components and assembly provide repeatability In a simple standalone procedure, iDose is implanted ab interno through a clear corneal incision 02 Small-molecule APIs with specific characteristics High potency (EC50 or IC50 < 10 nM) Low aqueous solubility Receptor does not lose sensitivity during long- term dosing Side effects may be reduced by intracameral versus topical delivery Molecular structure is chemically stable over time
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Day | September 14, 2017 | © 2017 Glaukos Corporation • Combining core competencies in micro-scale ocular devices with micro-electromechanical systems (MEMS) • Developing initial implantable IOP sensor system designed to record, transmit and report IOP for more effective glaucoma disease management • Generally limited resourced effort until proof-of-concept is realized • Long-term vision to build institutional MEMS capability to combine MEMS biosensor technology with additional diagnostic tools and IOP management innovations Platform Pillars: MEMS Biosensors IOP diagnostics and management Goal to provide micro-scale implantable tools for monitoring and managing IOP MEMS Biosensors
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Day | September 14, 2017 | © 2017 Glaukos Corporation Strategy Leverage micro-scale designs and clinical data to develop a long-term implantable device capable of recording, transmitting and reporting intraocular pressure IOP Micro-Sensor System Overview Functionality Sensor will record (up to once per hour), transmit (to patient- worn secondary device) and report (remotely, on-demand) IOP levels to the MD for use with patient Utility MD can make data-driven treatment decision based on direct IOP measurements taken 24/7/365 to determine if current therapies are providing the targeted therapeutic effect or if patent compliance is a factor Opportunity Quicker, objective decisions to maintain or alter treatment in patients with advanced glaucoma. Natural and opportune implantation of Glaukos IOP sensor at the time of iDose Travoprost or iStent device implantation or any concomitant ophthalmic surgery
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Day | September 14, 2017 | © 2017 Glaukos Corporation Summary
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Day | September 14, 2017 | © 2017 Glaukos Corporation Financial Goals 2020+ > 80% > 30% Substantial Market Opportunity Shift Gross Margin Potential Operating Margin Potential Key Variables Product launch timing and mix Long-term reimbursement trends US/OUS mix Competition dynamics Manufacturing costs at scale
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Day | September 14, 2017 | © 2017 Glaukos Corporation Glaukos: Key Takeaways Delivering novel surgical and pharmaceutical glaucoma therapy • Validating the narrative of sustained glaucoma drug delivery • Extending leadership in MIGS treatment class with industry’s most comprehensive surgical offering • Addressing important unmet clinical needs in large and growing markets • Becoming a multi-faceted organization capable of transforming glaucoma therapy
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Day | September 14, 2017 | © 2017 Glaukos Corporation Panel Discussion – Overall Business, Market & Strategy Glaukos Management Tom Burns, President & CEO Chris Calcaterra, COO Joe Gilliam, CFO & SVP Corporate Development Jeff Wells PharmD, SVP Regulatory, Quality & Clinical Affairs Guest Surgeons Eric Donnenfeld MD John Berdahl MD
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Day | September 14, 2017 | © 2017 Glaukos Corporation 1
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