The document discusses micro-invasive glaucoma surgery (MIGS) and the CyPass micro-stent developed by Transcend Medical for treating glaucoma. It provides an overview of CyPass' development from 2005 to 2015, including pilot studies, ongoing clinical trials in the US and EU, and preliminary positive results showing reduced intraocular pressure. The document also discusses the potential of MIGS generally and CyPass specifically to provide an alternative between eye drop medications and more invasive surgeries like trabeculectomy for treating glaucoma.

1. ©2015 Transcend Medical All Rights Reserved 1GRF360
Sean Ianchulev, MD MPH
Chief Medical Officer, Transcend Medical
Clinical Associate Professor, UC San Francisco
What next?

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Concept Feasibility Development Validation
2005 20158+ generations

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Concept Feasibility Development Validation
2005 2015
1000+ Cases
Pilot COMBO and
POAG
Complete
100
COMPASS
US-IDE RCT
Combined
Ongoing
505
CYCLE
EU Post-Market
Combined &
POAG
Ongoing
509
DUETTE
EU Post-Market
POAG
65
Ongoing

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Concept Feasibility Development Validation
2005 2015
People

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Concept Feasibility Development Validation
2005 2015
$89M

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The Potential of Micro-Invasive Glaucoma Surgery
MIGS is designed to bridge the gap between medications
and conventional glaucoma surgery.
Chronic med use CyPass Micro-Stent

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The Potential of Micro-Invasive Glaucoma Surgery
MIGS is designed to bridge the gap between medications
and conventional glaucoma surgery.
Trabeculectomy CyPass Micro-Stent

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CyPass Micro-Stent: The Next-Generation of MIGS
Caution: Investigational device. Limited by Federal (US) law to investigational use only.

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Why the Suprachoroidal space?
Large continuous space > Large Absorptive Capacity > Pressure Gradient

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CyPass Clinical Outcomes: EU studies
25.5
16.9 16.6 15.8
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
Baseline M6 M12 M24
MeanIOP(mmHg)
-29% -27%% reduction -35%
With Phaco
CyCle Study
CyPass Only
DUETTE Study
24.5
17.7
16.8
0.0
5.0
10.0
15.0
20.0
25.0
30.0
BL (n=65) M6 (n=52) M12 (n=48)
MeanIOP(mmHg)

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CyPass Clinical Outcomes: Safety
Am J Ophthalmol. 2015 Mar 3

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COMPASS trial: landmark study for glaucoma device
• Terminal wash out at 12 and 24 months
• Strict criteria for re-introduction of meds
• Rigorous analysis of endothelial cell density
• Strong primary endpoint outcome: 2-year diurnal un-medicated IOP change
N = 240
COMPASS trialN = 505
iStent trial
N = 276 ABC trial
N = 212 TVT trial
N = 255 EMGT trial

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What is the Future of MIGS?
CyPass Vx Infusion System

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What is the Future of MIGS?

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Preliminary Analysis of ViscoPass 1-YR Results
-7.0
± 4.2
-8.7
± 7.8
-9.9
± 5.8
-12.0
-10.0
-8.0
-6.0
-4.0
-2.0
0.0
CyPass only
(n=21)
CyPass + 30 uL
(n=21)
CyPass + 60 uL
(n=21)
IntraocularPressureDifference,mmHg
Paired Mean ± SD Change in IOP, by group, Baseline to 12M timepoint

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Stent Technology in Ophthalmology
The Next Frontier
Neurovascular
Cadiovascular
Pulmonary
Gastrointestinal
Urological/
Gyncological
Peripheral
Ophthalmology
MIGS