PowerPoint Presentation

Differentiating MIGS for the Cataract Surgeon: The Hydrus Microstent from Ivantis

Dave Van MeterOIS @ ASCRSMay 5, 2016

Ivantis OverviewFounded 2007 by top coronary stent inventorsDeveloping the only minimally invasive microstent for glaucoma that dilates and reconstructs the primary outflow path of the eye (Schlemms canal)25 FTEs; based in Irvine, CA$107 MM raised to date ($71 MM B round closed last year)Global investor syndicate lead by NEA and DelphiOver 2,500 patients treated globally (21 countries, 80 surgeons)Nearly 50% of procedures in standalone surgeryAll Procedures in Studies or RegistriesCompleted enrollment in US Pivotal trial in May 2015

Investigational Device Only in US2

How Will Ivantis Differentiate in a Crowded MIGS Space?Technology the only device that truly reconstructs the eyes primary outflow pathway Superior Clinical Data within the initial served MIGS market (phaco/glaucoma)Well positioned to serve the standalone glaucoma market (3.5 MM)Leverage the scaffold platform to expand into more complex patients

Investigational Device Only in US3

Confidential - Proprietary to Ivantis3

The Hydrus MicrostentFlexible, biocompatible Schlemms canal scaffold

Scalloped and open design allows aqueous flow

3 clock-hour length targets multiple collector channels

** Investigational Device Only in USA4Investigational Device Only in US

Confidential - Proprietary to Ivantis4

Hydrus Surgical Video

Investigational Device Only in US5

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How Will Ivantis Differentiate in a Crowded MIGS Space?Technology the only device that truly reconstructs the eyes primary outflow pathway Superior Clinical Data within the initial served MIGS market (phaco/glaucoma)Well positioned to serve the standalone glaucoma market (3.5 MM)Leverage the scaffold platform to expand into more complex patients

Investigational Device Only in US6

Confidential - Proprietary to Ivantis6

HYDRUS II: Level One Clinical EvidenceTrial was designed to closely simulate US pivotal trial Utilizes the state of the art study design standards utilized in current FDA MIGS trialsMedications removed (washout) prior to surgery and 1 and 2 year follow-ups to remove confounding effect of medications on IOP 7 top EU academic centers (Norbert Pfeiffer, PI) 100 eyes with mild to moderate OAG undergoing cataract surgery1:1 randomization day of surgeryAverage patient entered study at IOP of 19 on 2 meds; washout IOP was 26.57

The HYDRUS II Trial was recently published in Ophthalmologyand Awarded a Top 10 Paper at the American Glaucoma Society Meeting - 2015

Investigational Device Only in US7

Confidential - Proprietary to Ivantis7

TREATMENT RESPONSE Analysis conducted on intention-to-treat basis.(N=50)(N=50)(N=50)(N=50)= 34%P = 0.0008Hydrus increases response by74% compared to cataract surgery aloneHYDRUS II: ResultsInvestigational Device Only in US8

Confidential - Proprietary to Ivantis8

How Will Ivantis Differentiate in a Crowded MIGS Space?Technology the only device that truly reconstructs the eyes primary outflow pathway Superior Clinical Data within the initial served MIGS market (phaco/glaucoma)Well positioned to serve the standalone glaucoma market (3.5 MM)Leverage the scaffold platform to expand into more complex patients

Investigational Device Only in US9

Confidential - Proprietary to Ivantis9

Understanding the Standalone MIGS OpportunityA large gap between medical therapy/SLT and trabeculectomy surgery can be filled by MIGSEfficacy must be clinically meaningful (without help of cataract surgery)For earlier treatment, safety should be nearly on par with current treatment (meds/SLT)Hydrus is potentially uniquely positioned for this gap through its safe reconstruction of natural canalInvestigational Device Only in US10

The Life of the Glaucoma PatientGlaucoma Treatment Algorithm Today (Pre-MIGS)1st Med2nd Med3rd & 4th MedTrabthenTube

SLTCyclo destructive Potential Glaucoma Treatment in 2021 (Post-MIGS)1st Med or SLTSch. CanalMIGS2nd MedTrabthenTube

S. ChoroidalMIGSSubConj.MIGS

MildAdvanced

Least InvasiveMost Invasive~IOP Target 18~ IOP Target 10

Restore Primary FlowBypass Primary FlowBleb/ScleraInvestigational Device Only in US11

Confidential - Proprietary to Ivantis11

Hydrus in Standalone MIGSSPECTRUM Registry: 50% of elective Hydrus surgeries performed in standalone surgery globally in full spectrum of OAGCOMPARE Study: Ike Ahmed, Medical Monitor152 patients from 12 international MIGS expert centersLandmark prospective, multicenter randomized trial for MIGS in mild to moderate OAG Expected to show viability of canal-based MIGS in standalone populationIntend to pursue IDE Trial in USInvestigational Device Only in US12

Confidential - Proprietary to Ivantis12

How Will Ivantis Differentiate in a Crowded MIGS Space?Technology the only device that truly reconstructs the eyes primary outflow pathway Superior Clinical Data within the initial served MIGS market (phaco/glaucoma)Well positioned to serve the standalone glaucoma market (3.5 MM)Leverage the scaffold platform to expand into more complex patients

Investigational Device Only in US13

Confidential - Proprietary to Ivantis13

Leveraging the Hydrus Platform24 Hour IOP MonitorMicro pressure sensor housed within HydrusWireless link to a smart phone

Hydrus drug eluting coatingProven DES technologySustained release 8-16 months to TM, SC, or AC

Timed release bio- resorbable drug delivery platformTarget the TM, SC, or AC

Diagnostics Therapeutics Advanced Disease

Investigational Device Only in US14

Confidential - Proprietary to Ivantis14

Thank YouInvestigational Device Only in US15