Ivantis Overview
David Van Meter
OIS @ ASCRS
April 16, 2015
Investigational Device Only in US 1
Ivantis Overview
• Founded 2007 by top coronary stent inventors
• Developing a minimally invasive microstent for glaucoma
that dilates and scaffolds the natural outflow path of the eye
• 27 FTE’s; based in Irvine, CA
• $107 MM raised to date ($71 MM B round closed last year)
• Global investor syndicate lead by NEA and Delphi
• Over 2,000 patients treated globally
• 21 countries and 75 surgeons
• All patients either in Level One RCT’s or Global “Real
World” Registry
• Just completed recruitment in 558 subject US pivotal trial
Investigational Device Only in US 2
The Hydrus™ Microstent
Flexible, biocompatible
Schlemm’s canal
“scaffold”
Scalloped and open
design allows aqueous
flow
3 clock-hour length
targets multiple collector
channels
** Investigational
Device Only in
USA
3
Hydrus Surgical Video
Investigational Device Only in US 4
Commitment to Basic Science
5
Toris, Samuelson, Ahmed et al Outflow
IOVS 2013:54:1698-1704
Grierson,
Kahook, et al
3 month Monkey
Biocompatibility
Study
J Glaucoma
Nov 2013 ePub
ahead of printGong, Johnstone, et al. Fluorescent
Dye Intensity Study (AGS Paper 2013)
Johnstone,
Samuelson, et al
Collector
Channel
Preservation
Study
Experimental
Eye Research
2014;119:70-76
Investigational Device Only in US
Investigational Device Only in US 6
HYDRUS II Study
A Prospective, Multicenter, Controlled, Randomized Trial
Comparing Hydrus + Cataract to Cataract Alone
In Press: Ophthalmology
Top 10 Paper: AGS 2015
HYDRUS II:
Level One Clinical Evidence
• Trial was designed to closely simulate US pivotal trial
– Utilizes the “state of the art” study design standards utilized in
current FDA MIGS trials
– Medications 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
surgery
• 1:1 randomization day of surgery
• Average patient entered study at IOP of 19 on 2 meds;
washout IOP was 26.5
77Investigational Device Only in US
HYDRUS II: Results
100.0%
84.0% 83.7%
77.1%
83.3%
72.9%
47.9% 46.9%
50.0%
37.8%
0%
20%
40%
60%
80%
100%
Baseline 1M 6M 12M 18M 24M
%ofPatients
Medication Free Patients
Hydrus+CS CS
3 of 4 of Hydrus patients
vs. 1 of 3 cataract surgery
remain medication free
at 2 years
P=0.0008
Investigational Device Only in US 8
T R E AT M E N T R E S P O N S E
Investigational Device Only in US
9
88%
80%
74%
46%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
12 Months 24 Months
HYDRUS II: 20% Drop in Washed Out Diurnal IOP
Hydrus Control
Analysis conducted on intention-to-treat basis.
(N=50) (N=50) (N=50) (N=50)
= 34%
P = 0.0008
Hydrus
increases
response by
74% compared
to cataract
surgery alone
HYDRUS II: Results
Ivantis Summary
• Strong pre-clinical foundation through extensive
basic science
• Emphasis on Level One Clinical Evidence (multi
center RCT’s)
• Demonstrating an increasing effect over time relative
to control group in Level One Clinical Trial
• Global clinical experience in wide array of indications
(not just mild glaucoma with cataract)
• Well funded and now pursuing US FDA approval
Investigational Device Only in US 10

Ivantis

  • 1.
    Ivantis Overview David VanMeter OIS @ ASCRS April 16, 2015 Investigational Device Only in US 1
  • 2.
    Ivantis Overview • Founded2007 by top coronary stent inventors • Developing a minimally invasive microstent for glaucoma that dilates and scaffolds the natural outflow path of the eye • 27 FTE’s; based in Irvine, CA • $107 MM raised to date ($71 MM B round closed last year) • Global investor syndicate lead by NEA and Delphi • Over 2,000 patients treated globally • 21 countries and 75 surgeons • All patients either in Level One RCT’s or Global “Real World” Registry • Just completed recruitment in 558 subject US pivotal trial Investigational Device Only in US 2
  • 3.
    The Hydrus™ Microstent Flexible,biocompatible Schlemm’s canal “scaffold” Scalloped and open design allows aqueous flow 3 clock-hour length targets multiple collector channels ** Investigational Device Only in USA 3
  • 4.
  • 5.
    Commitment to BasicScience 5 Toris, Samuelson, Ahmed et al Outflow IOVS 2013:54:1698-1704 Grierson, Kahook, et al 3 month Monkey Biocompatibility Study J Glaucoma Nov 2013 ePub ahead of printGong, Johnstone, et al. Fluorescent Dye Intensity Study (AGS Paper 2013) Johnstone, Samuelson, et al Collector Channel Preservation Study Experimental Eye Research 2014;119:70-76 Investigational Device Only in US
  • 6.
    Investigational Device Onlyin US 6 HYDRUS II Study A Prospective, Multicenter, Controlled, Randomized Trial Comparing Hydrus + Cataract to Cataract Alone In Press: Ophthalmology Top 10 Paper: AGS 2015
  • 7.
    HYDRUS II: Level OneClinical Evidence • Trial was designed to closely simulate US pivotal trial – Utilizes the “state of the art” study design standards utilized in current FDA MIGS trials – Medications 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 surgery • 1:1 randomization day of surgery • Average patient entered study at IOP of 19 on 2 meds; washout IOP was 26.5 77Investigational Device Only in US
  • 8.
    HYDRUS II: Results 100.0% 84.0%83.7% 77.1% 83.3% 72.9% 47.9% 46.9% 50.0% 37.8% 0% 20% 40% 60% 80% 100% Baseline 1M 6M 12M 18M 24M %ofPatients Medication Free Patients Hydrus+CS CS 3 of 4 of Hydrus patients vs. 1 of 3 cataract surgery remain medication free at 2 years P=0.0008 Investigational Device Only in US 8
  • 9.
    T R EAT M E N T R E S P O N S E Investigational Device Only in US 9 88% 80% 74% 46% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 12 Months 24 Months HYDRUS II: 20% Drop in Washed Out Diurnal IOP Hydrus Control Analysis conducted on intention-to-treat basis. (N=50) (N=50) (N=50) (N=50) = 34% P = 0.0008 Hydrus increases response by 74% compared to cataract surgery alone HYDRUS II: Results
  • 10.
    Ivantis Summary • Strongpre-clinical foundation through extensive basic science • Emphasis on Level One Clinical Evidence (multi center RCT’s) • Demonstrating an increasing effect over time relative to control group in Level One Clinical Trial • Global clinical experience in wide array of indications (not just mild glaucoma with cataract) • Well funded and now pursuing US FDA approval Investigational Device Only in US 10