breakout session: migscag pg 24 perspectives •migs is ‘exciting’ but we must be mindful that...

Breakout Session:

MIGS

OIS.NET #OISASCRS

NEW WORLD MEDICAL

RAFAEL

CHAN

GLAUKOS CORPORATION

CHRIS

CALCATERRA

CALIFORNIA PACIFIC MEDICAL CENTER

GEORGE

TANAKA, MD

ALLERGAN

RAMIN

VALIAN

SIGHT SCIENCES

PATRICK

SMALERICHARD

LEWIS, MD

SACRAMENTO EYE CONSULTANTS

Moderator

BREAKOUT SESSION: MIGS

3 © 2019 Glaukos Corporation

3

Chris M CalcaterraChief Operating Officer


All statements other than statements of historical facts included in this presentation

that address activities, events or developments that we expect, believe or anticipate

will or may occur in the future are forward-looking statements. Although we believe

that we have a reasonable basis for forward-looking statements contained herein,

we caution you that they are based on current expectations about future events

affecting us and are subject to risks, uncertainties and factors relating to our

operations and business environment, all of which are difficult to predict and many

of which are beyond our control, that may cause our actual results to differ

materially from those expressed or implied by forward-looking statements in this

presentation. These potential risks and uncertainties include, without limitation,

uncertainties about our ability to maintain profitability; our dependence on the

success and market acceptance of the iStent®; our ability to leverage our sales and

marketing infrastructure to increase market penetration and acceptance both in the

United States and internationally of our products; our dependence on a limited

number of third-party suppliers, some of which are single-source, for components of

our products; the occurrence of a crippling accident, natural disaster or other

disruption at our primary facility, which may materially affect our manufacturing

capacity and operations; maintaining adequate coverage or reimbursement by third-

party payors for procedures using the iStent or other products in development; our

ability to properly train, and gain acceptance and trust from, ophthalmic surgeons in

the use of our products; our ability to successfully develop and commercialize

additional products; our ability to compete effectively in the highly competitive and

rapidly changing medical device industry and against current and future competitors

(including MIGS competitors) that are large public companies or divisions of

publicly traded companies that have competitive advantages; the timing, effect and

expense of navigating different regulatory approval processes as we develop

additional products and penetrate foreign markets; the impact of any product liability

claims against us and any related litigation; the effect of the extensive and

increasing federal and state regulation in the healthcare industry on us and our

suppliers; the lengthy and expensive clinical trial process and the uncertainty of

outcomes from any particular clinical trial; our ability to protect, and the expense

and time-consuming nature of protecting, our intellectual property against third

parties and competitors that could develop and commercialize similar or identical

products; the impact of any claims against us of infringement or misappropriation of

third party intellectual property rights and any related litigation; and the market’s

perception of our limited operating history as a public company. These and other

known risks, uncertainties and factors are described in detail under the caption

“Risk Factors” and elsewhere in our filings with the Securities and Exchange

Commission, including our Annual Report on Form 10-K for 2018 and Quarterly

Report on Form 10-Q for the quarter ended September 30, 2018. Our filings with

the Securities and Exchange Commission are available in the Investor Section of

our website at www.glaukos.com or at www.sec.gov. In addition, information about

the risks and benefits of our products is available on our website at

www.glaukos.gov. All forward-looking statements included in this press release

are expressly qualified in their entirety by the foregoing cautionary statements. You

are cautioned not to place undue reliance on the forward-looking statements in this

press release, which speak only as of the date hereof. We do not undertake any

obligation to update, amend or clarify these forward-looking statements whether as

a result of new information, future events or otherwise, except as may be required

under applicable securities law.

Disclaimer


OAGProgression

OCULAR

HYPERTENSION

MILD

MODERATEADVANCED

REFRACTORY

Addressing full range of

glaucoma disease states

and progression

Injectable drug delivery implant; sustained

drug therapy for extended periods

Envision use alone or in combination with

other MIGS devices

Injectable 2-stent

therapy for standalone

procedures

Injectable 2-stent

therapy for combo-

cataract procedures

Accesses secondary outflow

pathway; envision use primarily

in combination with other MIGS

devices

Injectable 3-stent

therapy for standalone

procedures

Portfolio of Micro-Scale Injectable Therapy

REFRACTORYADVANCEDMODERATEMILDOCULAR

HYPERTENSION

Single stent therapy

for combo-cataract

procedures

TM

TM

®

iStent SA, iStent Supra, iStent infinite and iDose are not

approved by the FDA.


OAGProgression

OCULAR

HYPERTENSION

MILD

MODERATEADVANCED

REFRACTORY

2021-22

2018

2020

2020-21

5 in 5: Estimated Cadence of Major New US Product Introductions

REFRACTORYADVANCEDMODERATEMILDOCULAR

HYPERTENSION

2023

iStent SA, iStent Supra, iStent infinite and iDose are not

approved by the FDA.

Addressing full range of

glaucoma disease states

and progression

TM

TM

2012

®


7

Excisional Goniotomy Using TheKahook Dual Blade®

Rafael Chan

VP/Chief Commercial Officer

New World Medical

Goniotomy: Traditional versus Excisional

9

TRADITIONAL GONIOTOMY

• Primarily used to treat congenital

glaucoma in pediatric patients

• Inability to lift trabecular meshwork (TM)

• Incisional procedure often with residual

leaflets and scarring

EXCISIONAL GONIOTOMY

• Option for pediatric and adult patients across

severity of disease

• Elevate and excises TM to access multiple collector

channels

• Excisional procedure minimizes residual TM leaflets

Kahook Dual Blade® is Designed for Trabecular Meshwork Excision

10

Dual blades

Tip

Ramp

Heel Ramp lifts TM to stretch

Dual blades excise TM

Tip pierces TM, then seat the Heel

1

2

3

Excisional Goniotomy Using the Kahook Dual Blade®

• Excision and removal of tissue to access multiple collector channels

• Implant-free procedure

• Can be performed stand-alone or combined with cataract surgery

• Established Category I code (CPT 65820)1

111. Mattox C and Vicchrilli S. (2018, May) How to Code for Glaucoma Procedures in the Anterior Chamber Angle. EyeNet, 50.

Humanitarian Product Donations

• Provide unlimited no-charge products for patients unable to afford care

• https://www.newworldmedical.com/NewWorldMedical/ProductRequest

12

https://www.newworldmedical.com/NewWorldMedical/ProductRequest

OIS MIGS Breakout – ASCRS 2019OMNI Surgical Didactic Presentation - 06005.A 13Copyright 2019 - Sight Sciences, Inc.

OMNI™ Surgical SystemPatrick Smale, VP of Marketing, Surgical

MIGS Breakout SessionOIS @ ASCRS 2019

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The Sight Sciences Mission

Transforming Ophthalmology and Optometry by addressing the underlying causes of the world’s most prevalent eye diseases

OIS MIGS Breakout – ASCRS 2019

15

Our Focus: Two of the Largest Unmet Needs in Eye Care

MICRO-INVASIVE GLAUCOMA SURGERY(MIGS)

DRY EYE DISEASE

Global Patents for Surgical Glaucoma50 Global Patents for Dry Eye Disease20

2019


16

The OMNI™ Surgical System – An Important Evolution in MIGS

INDICATION

Ab-externoTrabeculotomy

Ab-externoCanaloplasty

Ab-internoTrabeculotomy

(TRAB®360)

Ab-internoTransluminal

Viscoelastic Delivery (VISCO360®)

1969 2009 2013 2014 2018


17

Introducing the Next-Generation OMNI™ Surgical System

New look and feel based on surgeon feedback!


18

OMNI™ Surgical System

Combines two distinct implant-free procedures in one device

Transluminal viscoelastic delivery

Titratable trabeculotomy

Each of these procedures is sufficiently established to have its own Category 1 CPT code

Standalone procedure or in conjunction with cataract surgery

Targets three points of resistance in the conventional outflow pathway:

1. Trabecular Meshwork

2. Schlemm’s Canal

3. Distal Collector Channels


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Setting our SIGHTs on the Standalone Market

The Right Time


The Right Technology

The Right Team

• Thousands of MIGS-Trained Surgeons• Hundreds of thousands of Combo procedures• Millions of patients on topical medication • The Era of Interventional Glaucoma1

INDICATION

The OMNI™ Surgical System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example Healon® or HealonGV® from Abbott Medical Optics (AMO), Amvisc® from Bausch & Lomb, or PROVISC® from Alcon, during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures.

1. Ike K Ahmed, MD; 2018 New Horizons Forum Keynote. 7th Annual Glaucoma 360 New Horizons Forum, February 2018

OIS MIGS Breakout – ASCRS 2019OMNI Surgical Didactic Presentation - 06005.A 20Copyright 2019 - Sight Sciences, Inc.

Learn More at omnisurgical.comFor important safety information, please visit omnisurgical.com

21

MIGS breakout session OIS@ASCRS May 2nd

Hilton San Diego Bayfront

Ramin Valian

Vice President, Interventional Glaucoma,

Reimbursement, and Pipeline-US

22

XEN GEL STENT

• 6-mm length, 45-micron diameter

• Creates a permanent channel through the sclera allowing flow of aqueous humor from the anterior chamber into the subconjunctival space

• Gelatin, hydrates and swells, softens, and becomes flexible after implantation

• 27-gauge, longitudinal placement guidance (leaves approximately 1 mm of the implant in the anterior chamber)

• XEN is a leader in low teens efficacy, available in >30 countries with broad coverage in the US

23

SOLO IN PHAKIC

SOLO IN PSEUDOPHAKIC

COMBO

POAG

PXFNAG

CAG

PG

24

Perspectives

• MIGS is ‘exciting’ but we must be mindful that glaucoma is a progressive disease

• Interventional Glaucoma

• Something has to change – the treatment paradigm has yet to catch up to new and emerging treatment options, including Drug Delivery

• We must continue to deliver value to patients, providers and payors:

• Increased expectations around risk benefit profile

• Crowded market requires innovation is truly differentiated to gain coverage

• Patients are more engaged in their care and glaucoma treatment selection

How I ChooseWhich MIGS onWhich Patient

How we do MIGS now

• There is no comparative data

• We don’t know what we’re treating

• Based on reimbursement

The Glaucoma Tsunami

The future glaucoma patient

• Living longer

• Working longer

• More active

• Earlier diagnosis

• Better informed of treatment options

MedicationsProstaglandinsBeta BlockersAlpha AgonistsCAIsNitric oxideROCK inhibitors

Laser Treatment

Selective LaserTrabeculoplasty

Filtration Surgery

Trabeculectomy

Drainage Implant

Tube Shunts

Where Does MIGS Fit?

Glaucoma surgery back then

trabeculectomy tube shunt cyclodestruction

Glaucoma surgery today

• External suprachoroidal

• Gold Micro-Shunt (SOLX)

• External sub-conjunctival

• MicroShunt (Santen-Glaukos)

• iStent Inject (Glaukos)

• Hydrus (Ivantis)

• CyPass (Alcon) WITHDRAWN

• iStent Supra (Glaukos)

• MINIject (iSTAR)

trabeculectomy tube shunt cyclophotocoagulation

MIGS

FDA approved

Aqueous humor outflow system

Trabecular meshwork

(TM)

Internal (TM implant)

TM-Canal

iStentiStent

Inject Hydrus

Mild glaucoma

With cataract

Internal (TM removal)

Kahook Dual Blade

OMNI

Trabectome

GATT

TM-Canal

Mild to Moderate glaucoma

With or without cataract

Younger phakic

Older pseudophakic


Distal outflow system

dysfunction-resistance-atrophy

Moderate to Severe glaucoma

Internal (TM bypass)

Suprachoroidal

CypassiStent

Supra

XEN

MINIject


Without (or with) cataract

External: trab, trab-ExPress, tube

XEN

MicroShunt


Without (or with) cataract


Distal outflow system

dysfunction-resistance-atrophy

www.unitedcardiology.com.au,www.healthline.com

Focal, mild disease

Multivessel, severe disease

Coronary stent

www.unitedcardiology.com.au,www.healthline.com

Coronary stent

MILD

DISEASE

SEVERE

DISEASE

?

What is the segmental distal outflow potential?

Implant or Remove or Bypass

?

The problem with how we do MIGS

• Currently there is no method of visualizing

or assessing distal outflow pre-operatively

• Intra-operative distal outflow can be seen

• Potential markers for distal outflow capacity

• Disease severity

• SLT response

= ?

Distal outflow pathway: aqueous veins

Ike Ahmed, AGS 2015 Lecture “MIGS 2.0”

PAIN

GAIN

“No pain, no gain”

MIGS Reimbursement Issues

• TM implants only covered with cataract

surgery

• Poor reimbursement for all MIGS with some

MACs (Noridian)

• Some MIGS not covered by commercial

insurers (“experimental” “not medically

necessary”)

How we do MIGS now

• There is no comparative data

• We don’t know what we’re treating

• Based on reimbursement

Thank you

OIS.NET #OISASCRS

NEW WORLD MEDICAL

RAFAEL

CHAN

GLAUKOS CORPORATION

CHRIS

CALCATERRA

CALIFORNIA PACIFIC MEDICAL CENTER

GEORGE

TANAKA, MD

ALLERGAN

RAMIN

VALIAN

SIGHT SCIENCES

PATRICK

SMALERICHARD

LEWIS, MD

SACRAMENTO EYE CONSULTANTS

Moderator

BREAKOUT SESSION: MIGS

breakout session: migscag pg 24 perspectives •migs is ‘exciting’ but we must be mindful that...

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