Eric Donnenfeld, MD "MIGS From the Perspective of a Cataract Surgeon" presentation from OIS@ASCRS 2015

1. 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

2. Disclosure: Eric Donnenfeld, M.D.
 Acufocus
 Allergan
 Alcon
 AMO
 Aquesys
 Bausch & Lomb
 Beaver-visitec
 CRST
 Elenza
 Glaukos
 Icon Biosciences
 Kala
 Katena
 Lacripen
 Mati Pharmaceuticals
 Merck
 Mimetogen
 I am a consultant for:
 Novabay
 Novaliq
 Ocuhub
 Odyssey
 Omeros
 Pfizer
 PRN
 RPS
 Shire
 Strathspey Crown
 Tearlab
 TearScience
 TLC Laser Centers
 TrueVision
 Versant Ventures
 Wavetec
 Zeiss

3. MIGS: Mechanism of Action
 Subconjunctival
 Aquesys (XEN)
 Canal
 Glaukos (iStent & iStent inject)
 Ivantis (Hydrus)
 Suprachoroidal
 Transcend (CyPass)
 Glaukos (iStent Supra)

4. What are the Differences Between a
Glaucoma and Refractive Cataract
Surgeon?
 Glaucoma
 Primary concern: IOP
 Goal: Prevent
blindness
 Tolerates
complications
 Lower surgical volume
 Typical patient: End
stage glaucoma
 Cataract
 Primary concern:
Safety
 Goal: Quality of life
 Hates complications
 Higher surgical volume
 Typical patient: Ocular
hypertension

5.  Safety
 Efficacy
 Economics
Determinants of Success and
Concerns

6. “First, do no harm.”
Hippocrates,
Founder of Western Medicine

7. Traditional Glaucoma Surgery
Post-op complication rate at 2 years approaches 50%

8. U.S. Pivotal Trial
Safety Through Two Years Postoperative1
iStent + cataract
surgery (n=116)
Cataract surgery
only (n=117)
Ocular Complications*
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%
Stent or Glaucoma-Related 2nd Surgeries
Stent repositioning/replacement or laser
iridoplasty (for stent
malposition/obstruction)
4% NA
Trabeculoplasty 1% 2%
Deep sclerectomy/sclerostomy 0% 1%* ≥ 4% in either group
1 iStent® Trabecular Micro-Bypass Stent: Directions for Use, Part # 45-0074 rev 2.
Safety Profile Similar to Cataract Surgery Alone

9. MIGS Safety Profile
0.00%
0.10%
0.20%
0.30%
0.40%
0.50%
0.60%
0.70%
0.80%
0.90%
1.00%
Q1 Q2 Q3 Q4
Adverse Events
Very favorable risk/benefit
ratio
Adverse events uncommon
Source: GTS100 R/L. Data on file with Glaukos Corporation.

10. Determinants of Success and Concerns
 Safety
 Efficacy
 Economics

11. 0
25
50
75
100
50
72
0
25
50
75
100
48
66
%eyes
excludes data after 2nd surgery
p < 0.001
Cat sx only iStent + Cat sx
M12 IOP  ≥ 20% w/o medsM12 IOP ≤ 21 mmHg w/o meds
p = 0.003
Cat sx only iStent + Cat sx
iStent US IDE Trial:
Primary and Secondary Endpoints
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.

12. 19.8
25.0
11.5
12.2 12.2
12.8 13.1
14.4
14.8
15.9
20.1
25.0
11.9
12.3 12.5
13.0 13.5
12.8
13.6
13.8
20.4
24.9
12.1
12.0
12.0 12.8 12.9
12.2
12.7 12.1
8
12
16
20
24
28
Scr
(n=38, 41, 40)
BL
(n=38, 41, 40)
D1
(n=38, 41, 40)
W1
(n=38, 41, 40)
M1
(n=38, 41, 40)
M3
(n=38, 41, 40)
M6
(n=38, 41, 40)
M12
(n=37, 41, 38)
M12-13*
(n=37, 41, 38)
M18 (n=37,
41, 38)
1-stent
2-stent
3-stent
1 vs. 2 vs. 3 iStents Implanted as Sole
Procedure (MIGS Study Group)
preop med
washout
M12 med
washout*
excludes data after secondary surgery
*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
M12
Mean IOP Over Time
MeanIOP(mmHg)
Katz LJ. 2015 ASCRS, San Diego, CA.

13. 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.

14. Traditional Glaucoma Surgery Profiles
 MIGS
 Mild to moderate
disease
 Open angles
 Modest IOP (15-16)
 Low risk
 Long term data lacking
 Trab or Tube
 More advanced
disease
 Open or closed
angles
 Lower IOP (<13)
 Higher risk
 Recognized long term
effect

15. Changing Glaucoma Surgery Profile
 Glaucoma surgery is becoming a staged procedure
due to the low risk of complications and increased
efficacy of MIGS
 Patients are embracing the low risk option of MIGS
 MIGS are now primary surgical therapy
 MIGS do not alter the ocular anatomy for future
surgery
 Traditional glaucoma surgery reserved for only the
most severe candidates
 Glaucoma specialists are embracing MIGS

16.  Safety
 Efficacy
 Economics
Determinants of Success and Concerns

17. Cataract Only
79.5%
Comorbid
OAG / OHT
20.5%
3.5M US Cataract Procedures
717K
Centers for Medicare and Medicaid Services. 2002 – 2007. Medicare Standard Analytical File.
Baltimore, MD. 2007
Concomitant Cataracts (US)
1 in 5 co-morbid cataract eyes
Significant Treatment Opportunity

19. Glaucoma Medications
Patient & System Costs
*Medicare Statistical Analytic File. Cataract patients with
Glaucoma.
 MIGS are cost effective

20. Economic Analysis
Surgeon Reimbursement
1 Medicare National Average. Actual physician reimbursement varies by payer
Surgeon
iStent $8501
Cataract Surgery $6671
Reduction (50% of 66984) ($333)
Total Surgeon Reimbursement $850+$333=$1183
Incremental Reimbursement $1183 - $667= $517

21. Economic Analysis
Facility Reimbursement
* Medicare National Fee Schedule
2015 ASC
CPT Code 66984 0191T Total Increm.
APC Group 0233 0673
Stand alone procedure 960.64 $1,711.63
66984 + 0191T $480.32 $1,711.63 $2,191.95 $1,231.31
2015 Hospital Outpatient Department
CPT Code 66984 0191T Total Increm.
APC Group 0233 0673
Stand alone procedure $1,751.53 $3,121.34
66984 + 0191T $875.76 $3,121.34 $3,997.10 $2,243.57

22. 0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
Q1 13 Q2 13 Q3 13 Q4 13 Q1 14 Q2 14 Q3 14 Q4 14
MIGS Gaining Acceptance
> 65,000 Units Since U.S. Launch
CONFIDENTIAL

23. MIGS Use Will Increase
 Insurance approval for ocular hypertension
 Insurance approval for multiple MIGs devices
 Expansion of use beyond cataract surgery
 Patient demand
 Ease of use will improve
 Physician reimbursement

24. iStent iStent Inject
iStent vs iStent Inject

25. Trabeculectomy Xen Procedure
XEN Procedure vs Trabeculectomy
Video: J. Batlle, MD

26. NOECKER- 2011
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.

27. Conclusion:
MIGS Market Opportunity
 Improves patient quality of life
 Reducing or perhaps eliminating the need for
glaucoma medications
 Safety and efficacy
 Embraced by glaucoma surgeons, cataract
surgeons and patients
 Cost effective for surgeons, surgicenters and
patients
My new gold standard with cataract surgery is a safe
procedure with no postop glasses or glaucoma
medications

28. Thank You