Presentation from OIS@ASCRS 2016
Dave Van Meter, President & CEO
Video Presentations:
https://www.youtube.com/watch?v=aisY-FTnTyM&index=26&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw
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SPOTLIGHT ON MIGS - Ivantis
1. Differentiating MIGS for the
Cataract Surgeon: The Hydrus
Microstent from Ivantis
Dave Van Meter
OIS @ ASCRS
May 5, 2016
2. Ivantis Overview
• Founded 2007 by top coronary stent inventors
• Developing the only minimally invasive microstent for
glaucoma that dilates and reconstructs the primary outflow
path of the eye (Schlemm’s canal)
• 25 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 2,500 patients treated globally (21 countries, 80
surgeons)
• Nearly 50% of procedures in “standalone” surgery
• All Procedures in Studies or Registries
• Completed enrollment in US Pivotal trial in May 2015
Investigational Device Only in US 2
3. How Will Ivantis Differentiate in a
Crowded MIGS Space?
• Technology – the only device that truly
reconstructs the eye’s 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 US 3
4. 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
4Investigational Device Only in US
6. How Will Ivantis Differentiate in a
Crowded MIGS Space?
• Technology – the only device that truly
reconstructs the eye’s 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 US 6
7. 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
7
The HYDRUS II Trial was recently published in Ophthalmology
and
Awarded a Top 10 Paper at the
American Glaucoma Society Meeting - 2015
Investigational Device Only in US 7
8. T R E AT M E N T R E S P O N S E
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
Investigational Device Only in US 8
9. How Will Ivantis Differentiate in a
Crowded MIGS Space?
• Technology – the only device that truly
reconstructs the eye’s 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 US 9
10. Understanding the Standalone
MIGS Opportunity
• A large gap between medical therapy/SLT and
trabeculectomy surgery can be filled by MIGS
• Efficacy 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 canal Investigational Device Only in US 10
11. The Life of the Glaucoma Patient
Glaucoma Treatment Algorithm Today (“Pre-MIGS”)
1st Med
2nd Med
3rd & 4th Med
Trab
then
Tube
SLT
Cyclo destructive
Potential Glaucoma Treatment in 2021 (“Post-MIGS”)
1st Med
or SLT
Sch. Canal
MIGS
2nd Med
Trab
then
Tube
S. Choroidal
MIGS
Sub
Conj.
MIGS
Mild Advanced
Least Invasive Most Invasive
~IOP Target 18 ~ IOP Target 10
Restore Primary Flow Bypass Primary Flow Bleb/ScleraInvestigational Device Only in US 11
12. Hydrus in Standalone MIGS
• SPECTRUM Registry: 50% of elective Hydrus
surgeries performed in standalone surgery globally
in full spectrum of OAG
• COMPARE Study:
– Ike Ahmed, Medical Monitor
– 152 patients from 12 international MIGS expert centers
– Landmark prospective, multicenter randomized trial for
MIGS in mild to moderate OAG
– Expected to show viability of canal-based MIGS in
standalone population
• Intend to pursue IDE Trial in US
Investigational Device Only in US 12
13. How Will Ivantis Differentiate in a
Crowded MIGS Space?
• Technology – the only device that truly
reconstructs the eye’s 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 US 13
14. Leveraging the Hydrus Platform
• 24 Hour IOP Monitor
• Micro pressure sensor
housed within Hydrus
• Wireless link to a
smart phone
• Hydrus drug eluting
coating
• Proven DES technology
• Sustained release 8-16
months to TM, SC, or AC
• Timed release bio-
resorbable drug delivery
platform
• Target the TM, SC, or AC
DiagnosticsTherapeuticsAdvancedDisease
Investigational Device Only in US 14