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MIGS From the Perspective of a
Cataract Surgeon
Eric Donnenfeld, M.D.
Ophthalmic Consultants of Long Island
Clinical Professor of Ophthalmology NYU
Trustee Dartmouth Medical School
Disclosure: Eric Donnenfeld, M.D.
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I am a consultant for:
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Acufocus
Allergan
Alcon
AMO
Aquesys
Bausch & Lomb
Beaver-visitec
CRST
Elenza
Glaukos
Icon Biosciences
Kala
Katena
Lacripen
Mati Pharmaceuticals
Merck
Mimetogen
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Novabay
Novaliq
Ocuhub
Odyssey
Omeros
Pfizer
PRN
RPS
Shire
Strathspey Crown
Tearlab
TearScience
TLC Laser Centers
TrueVision
Versant Ventures
Wavetec
Zeiss
MIGS: Mechanism of Action
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Subconjunctival
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Aquesys (XEN)
Canal
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Glaukos (iStent & iStent inject)
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Ivantis (Hydrus)
Suprachoroidal
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Transcend (CyPass)
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Glaukos (iStent Supra)
What are the Differences Between a
Glaucoma and Refractive Cataract
Surgeon?
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Glaucoma
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Cataract
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Primary concern: IOP
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Goal: Prevent
blindness
Primary concern:
Safety
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Goal: Quality of life
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Hates complications
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Higher surgical volume
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Typical patient: Ocular
hypertension
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Tolerates
complications
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Lower surgical volume
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Typical patient: End
stage glaucoma
Determinants of Success and
Concerns
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Safety
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Efficacy
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Economics
“First, do no harm.”
Hippocrates,
Founder of Western Medicine
Traditional Glaucoma Surgery
Post-op complication rate at 2 years approaches 50%
U.S. Pivotal Trial
Safety Through Two Years Postoperative1
iStent + cataract
surgery (n=116)
Cataract surgery
only (n=117)
Early postop corneal edema
8%
9%
Any BCVA loss ≥ 1 line at ≥ 3 months
7%
10%
Posterior capsular opacification
6%
10%
Stent obstruction
4%
NA
Blurry vision or visual disturbance
3%
7%
Elevated IOP - other
3%
4%
Iritis
1%
5%
Mild pain
0%
4%
Ocular Complications*
Stent or Glaucoma-Related 2nd Surgeries
Stent repositioning/replacement or laser
iridoplasty (for stent
malposition/obstruction)
4%
NA
Trabeculoplasty
1%
2%
0%
Alone
* ≥ 4% in1%
either group
Deep
sclerectomy/sclerostomy
Safety
Profile Similar to Cataract Surgery
1
iStent® Trabecular Micro-Bypass Stent: Directions for Use, Part # 45-0074 rev 2.
MIGS Safety Profile
Adverse Events
1.00%
Very favorable risk/benefit
ratio
0.90%
0.80%
0.70%
0.60%
Adverse events uncommon
0.50%
0.40%
0.30%
0.20%
0.10%
0.00%
Q1
Q2
Q3
Q4
Source: GTS100 R/L. Data on file with Glaukos Corporation.
Determinants of Success and Concerns
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Safety
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Efficacy
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Economics
iStent US IDE Trial:
Primary and Secondary Endpoints
100
100
M12 IOP ≤ 21 mmHg w/o meds
75
75
% eyes
p < 0.001
50
M12 IOP  ≥ 20% w/o meds
72
p = 0.003
66
50
50
48
25
25
0
Cat sx only
iStent + Cat sx
0
Cat sx only
iStent + Cat sx
excludes data after 2nd surgery
Samuelson TW, Katz LJ, Wells JM, Duh Y-J, Giamporcaro JE. Randomized evaluation of the trabecular micro-bypass stent with
phacoemulsification in patients with glaucoma and cataract. Ophthalmology 2011;118:459-467.
1 vs. 2 vs. 3 iStents Implanted as Sole
Procedure (MIGS Study Group)
28
preop med
washout
25.0
25.0
24.9
Mean IOP (mmHg)
24
20
1-stent
2-stent
3-stent
Mean IOP Over Time
20.4
20.1
19.8
M12 med
washout*
16
14.8
12.1
11.9
11.5
12
12.3
12.2
12.0
12.5
12.2
12.0
13.0
12.8
12.8
13.5
13.1
12.9
14.4
12.8
12.2
13.6
12.7
15.9
13.8
12.1
8
Scr
BL
D1
W1
M1
M3
M6
M12
M12-13*
M18 (n=37,
(n=38, 41, 40) (n=38, 41, 40) (n=38, 41, 40) (n=38, 41, 40) (n=38, 41, 40) (n=38, 41, 40) (n=38, 41, 40) (n=37, 41, 38) (n=37, 41, 38)
41, 38)
Katz LJ. 2015 ASCRS, San Diego, CA.
*11 eyes washed out of med at M12.
M12-13 IOP is M12 IOP for 105 eyes on 0 medication
and M13 IOP for 11 eyes washed out of medication at
excludes data after secondary surgery
M12
OUS DATA
*1 cataract combo case converted to tube at 4M
2 converted to Trab at 6M (both were post-tube)
© Copyright 2015. AqueSys and XEN Glaucoma Implant are registered trademarks of AqueSys, Inc. *AqueSys is not approved for sale in the United States. IDE approved investigative status.
Traditional Glaucoma Surgery Profiles
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MIGS
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Trab or Tube
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Mild to moderate
disease
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More advanced
disease
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Open angles
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Modest IOP (15-16)
Open or closed
angles
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Low risk
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Lower IOP (<13)
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Long term data lacking
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Higher risk
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Recognized long term
effect
Changing Glaucoma Surgery Profile
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Glaucoma surgery is becoming a staged procedure
due to the low risk of complications and increased
efficacy of MIGS
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Patients are embracing the low risk option of MIGS
MIGS are now primary surgical therapy
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MIGS do not alter the ocular anatomy for future
surgery
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Traditional glaucoma surgery reserved for only the
most severe candidates
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Glaucoma specialists are embracing MIGS
Determinants of Success and Concerns
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Safety
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Efficacy
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Economics
Concomitant Cataracts (US)
1 in 5 co-morbid cataract eyes
Significant Treatment Opportunity
3.5M US Cataract Procedures
Comorbid
OAG / OHT
20.5%
717K
Cataract Only
79.5%
Centers for Medicare and Medicaid Services. 2002 – 2007. Medicare Standard Analytical File.
Baltimore, MD. 2007
Glaucoma Medications
Patient & System Costs
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MIGS are cost effective
*Medicare Statistical Analytic File. Cataract patients with
Glaucoma.
Economic Analysis
Surgeon Reimbursement
Surgeon
iStent
$8501
Cataract Surgery
$6671
Reduction (50% of 66984)
($333)
Total Surgeon Reimbursement
$850+$333=$1183
Incremental Reimbursement
$1183 - $667= $517
1 Medicare
National Average. Actual physician reimbursement varies by payer
Economic Analysis
Facility Reimbursement
2015
CPT Code
APC Group
Stand alone procedure
66984 + 0191T
2015
CPT Code
APC Group
Stand alone procedure
66984 + 0191T
* Medicare National Fee Schedule
ASC
66984
0233
960.64
$480.32
0191T
0673
$1,711.63
$1,711.63
Total
Increm.
$2,191.95
$1,231.31
Hospital Outpatient Department
66984
0233
$1,751.53
$875.76
0191T
0673
$3,121.34
$3,121.34
Total
Increm.
$3,997.10
$2,243.57
MIGS Gaining Acceptance
> 65,000 Units Since U.S. Launch
14,000
12,000
10,000
8,000
6,000
4,000
2,000
0
Q1 13 Q2 13 Q3 13 Q4 13 Q1 14 Q2 14 Q3 14 Q4 14
CONFIDENTIAL
MIGS Use Will Increase
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Insurance approval for ocular hypertension
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Insurance approval for multiple MIGs devices
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Expansion of use beyond cataract surgery
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Patient demand
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Ease of use will improve
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Physician reimbursement
iStent vs iStent Inject
iStent
iStent Inject
XEN Procedure vs Trabeculectomy
Trabeculectomy
Xen Procedure
Video: J. Batlle, MD
The common ground of cataract and
refractive surgery is the rapid visual
rehabilitation, technology-driven
precision, safety, elegance, and efficacy
that improve patients’ quality of life. We
are now on the threshold of welcoming a
newcomer into our midst: minimally
invasive glaucoma surgery.
NOECKER- 2011
Conclusion:
MIGS Market Opportunity
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Improves patient quality of life
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Reducing or perhaps eliminating the need for
glaucoma medications
My
new and
goldefficacy
standard with cataract surgery is a safe
Safety
procedure with no postop glasses or glaucoma
 Embraced by glaucoma
surgeons, cataract
medications
surgeons and patients
Cost effective for surgeons, surgicenters and
patients
Thank You