The document discusses CyPass, a novel micro-invasive glaucoma surgery (MIGS) device that uses a supraciliary stent to enhance aqueous outflow through the suprachoroidal space. It provides data from clinical studies showing that CyPass lowers intraocular pressure by over 30% with a favorable safety profile. A new version called CyPass Vx is also mentioned as being developed to treat a broader range of glaucoma severity.

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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CyPass Supraciliary Stenting: Next Generation MIGS
• Novel aqueous outflow enhancement: non-trabecular
• Supraciliary vs trabecular stenting
• Ab interno, non-perforating, no bleb, no MMC
CyPass

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CyPass
CyPass Supraciliary Stenting: Next Generation MIGS
• Novel aqueous outflow enhancement: non-trabecular
• Supraciliary vs trabecular stenting
• Ab-interno, non-perforating, no bleb, no MMC

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CyPass Supraciliary Stenting: Next Generation MIGS
Continuous, absorptive reservoir
Single point access to the suprachoroidal
continuum with up to 160x more surface area vs
the trabecular meshwork2,3
Robust pressure gradient
Pressure differential between anterior chamber
and suprachoroidal space is 4 mmHg (at
physiological range)1
1. Emi K, Pederson JE, Toris CB. Hydrostatic pressure of the suprachoroidal space. IOVS. 30(2):233-238
2. Patel SR, Lin ASP, Edelhauser HF, Prausnitz MR. Suprachoroidal Drug Delivery to the Back of the Eye Using Hollow Microneedles. Pharm Res 2011
January;28(1):166–176
3. Internal analysis – Grierson (1979). BJO. 63:9-16; Olsen (1998). Am J Ophth. 125:237-241.
Anterior chamber
Supraciliary space
Suprachoroidal space
PRESSURE GRADIENT

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CyPass Supraciliary Stenting: Next Generation MIGS
• 3000 Cases worldwide
• Largest MIGS FDA trial complete
• Filed PMA with FDA (October 2015)

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Concept Feasibility Development Validation
2005 2015
3000+ Cases
Pilot COMBO and
POAG
Complete
100
COMPASS
US-IDE RCT
Combined
Complete
505
CYCLE
EU Post-Market
Combined &
POAG
Complete
500+
DUETTE
EU Post-Market
POAG
65
Complete
VISCOPASS
OUS Feasibility
Study POAG
Ongoing
135

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CyPass Clinical Outcomes: Mild –Moderate Glaucoma
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)
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)
Reduction: -32%

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CyPass Clinical Outcomes: Safety
Adverse Events n (%)
Hypotony Maculopathy 0 (0)
Suprachoroidal Hemorrhage 0 (0)
Other Retinal Complications 0 (0)
Retinal Detachment 0 (0)
Explanted Device 1 (0.7)
Device Repositioning 1 (0.7)
Iris Atrophy 0 (0)
Endophthalmitis 0 (0)
Adverse Events n (%)
Iritis >1M 1 (0.7)
Hypotony >1M (<6 mmHg) 0 (0)
IOP Increase >1M 4 (2.9)
Transient Hyphema <1M 2 (1.5)
Anterior Chamber Shallowing 0 (0)
Endothelial Touch 5 (3.7)
Peripheral Anterior Synechia
with partial or complete obstruction
12 (8.8)
BCVA Loss > 2 lines 0 (0)
Early Terminations (N=28)
• Secondary glaucoma surgery (N=15)
• Death (N=5)
• Subject’s decision (N=5)
• Other/Unspecified (N=3)
CyCLE study: CyPass combined with phaco, 24M (n=136)

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COMPASS trial
• 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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Next Generation Technology: CyPass Vx

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Mild Severe
360° Glaucoma Rx Spectrum
Moderate
CyPass CyPass Vx

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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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Efficacy in Mild-Severe Glaucoma
MIGS Safety Profile
No Bleb Yes
Yes
Yes
CYPASS
The Perfect MIGS Procedure
GonioFree Yes
Phaco + Yes
Best-in-class Validation (PMA) Yes