breakout session: migscag pg 24 perspectives •migs is ‘exciting’ but we must be mindful that...
TRANSCRIPT
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
4 © 2019 Glaukos Corporation
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
5 © 2019 Glaukos Corporation
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.
6 © 2019 Glaukos Corporation
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 © 2019 Glaukos Corporation
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Excisional Goniotomy Using TheKahook Dual Blade®
Rafael Chan
VP/Chief Commercial Officer
New World Medical
Goniotomy: Traditional versus Excisional
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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
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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
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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
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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
OIS MIGS Breakout – ASCRS 2019
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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
OIS MIGS Breakout – ASCRS 2019
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Introducing the Next-Generation OMNI™ Surgical System
New look and feel based on surgeon feedback!
OIS MIGS Breakout – ASCRS 2019
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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
OIS MIGS Breakout – ASCRS 2019
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Setting our SIGHTs on the Standalone Market
The Right Time
OIS MIGS Breakout – ASCRS 2019
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
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MIGS breakout session OIS@ASCRS May 2nd
Hilton San Diego Bayfront
Ramin Valian
Vice President, Interventional Glaucoma,
Reimbursement, and Pipeline-US
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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
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SOLO IN PHAKIC
SOLO IN PSEUDOPHAKIC
COMBO
POAG
PXFNAG
CAG
PG
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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
Aqueous humor outflow system
Distal outflow system
dysfunction-resistance-atrophy
Moderate to Severe glaucoma
Internal (TM bypass)
Suprachoroidal
CypassiStent
Supra
XEN
MINIject
Moderate to Severe glaucoma
Without (or with) cataract
External: trab, trab-ExPress, tube
XEN
MicroShunt
Moderate to Severe glaucoma
Without (or with) cataract
Aqueous humor outflow system
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