Transcend Medical

©2015 Transcend Medical All Rights Reserved 1GRF360

Sean Ianchulev, MD MPHChief Medical Officer, Transcend Medical

Clinical Associate Professor, UC San Francisco

What next?

2©2014 Transcend Medical All Rights Reserved

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


CyPass


• Novel aqueous outflow enhancement: non-trabecular

• Supraciliary vs trabecular stenting

• Ab-interno, non-perforating, no bleb, no MMC



Continuous, absorptive reservoirSingle point access to the suprachoroidal continuum with up to 160x more surface area vs the trabecular meshwork2,3

Robust pressure gradientPressure 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):233-2382. 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):166–1763. Internal analysis – Grierson (1979). BJO. 63:9-16; Olsen (1998). Am J Ophth. 125:237-241.

Anterior chamber

Supraciliary space

Suprachoroidal space

PRESSURE GRADIENT



• 3000 Cases worldwide

• Largest MIGS FDA trial complete

• Filed PMA with FDA (October 2015)


Concept Feasibility Development Validation

2005 20153000+ Cases

Pilot COMBO and POAG

Complete

100

COMPASSUS-IDE RCTCombined

Complete

505

CYCLEEU Post-MarketCombined & POAG

Complete

500+

DUETTEEU Post-MarketPOAG

65

Complete

VISCOPASSOUS Feasibility Study POAG

Ongoing

135


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

Mea

n IO

P (

mm

Hg)

Reduction: -35%

With PhacoCyCle Study

CyPass OnlyDUETTE Study

24.5

17.716.8

0.0

5.0

10.0

15.0

20.0

25.0

30.0

BL (n=65) M6 (n=52) M12 (n=48)

Mea

n IO

P (

mm

Hg)

Reduction: -32%


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 Synechiawith 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)


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


Next Generation Technology: CyPass Vx


Mild Severe

360° Glaucoma Rx Spectrum

Moderate

CyPass CyPass Vx


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)

Intr

aocu

lar

Pre

ssu

re D

iffe

ren

ce, m

mH

g

Paired Mean ± SD Change in IOP, by group, Baseline to 12M timepoint


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

Healthcare

Transcend Medical