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Ivantis Overview
David Van Meter
OIS @ ASCRS
April 16, 2015
Investigational Device Only in US
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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
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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
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Hydrus Surgical Video
Investigational Device Only in US
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Commitment to Basic Science
Johnstone,
Samuelson, et al
Collector
Channel
Preservation
Study
Experimental
Eye Research
2014;119:70-76
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 print
Gong, Johnstone, et al. Fluorescent
Investigational Device Only in US
Dye Intensity Study (AGS Paper 2013)
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HYDRUS II Study
A Prospective, Multicenter, Controlled, Randomized Trial
Comparing Hydrus + Cataract to Cataract Alone
In Press: Ophthalmology
Top 10 Paper: AGS 2015
Investigational Device Only in US
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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
Investigational Device Only in US
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HYDRUS II: Results
Medication Free Patients
100%
100.0%
84.0%
83.7%
77.1%
80%
% of Patients
P=0.0008
83.3%
72.9%
60%
47.9%
46.9%
50.0%
3 of 4 of Hydrus patients
vs. 1 of 3 cataract surgery
remain medication free
at 2 years
40%
20%
37.8%
0%
Baseline
1M
6M
Hydrus+CS
12M
18M
24M
CS
Investigational Device Only in US
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T R E AT M E N T R E S P O N S E
HYDRUS II: Results
HYDRUS II: 20% Drop in Washed Out Diurnal IOP
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
88%
80%
74%
= 34%
P = 0.0008
46%
(N=50)
(N=50)
12 Months
(N=50)
(N=50)
Hydrus
increases
response by
74% compared
to cataract
surgery alone
24 Months
Hydrus
Control
Analysis conducted on intention-to-treat basis.
Investigational Device Only in US
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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
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