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
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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.
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
MIGS: Mechanism of Action
Subconjunctival
Aquesys (XEN)
Canal
Glaukos (iStent & iStent inject)
Ivantis (Hydrus)
Suprachoroidal
Transcend (CyPass)
Glaukos (iStent Supra)
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
Safety
Efficacy
Economics
Determinants of Success and Concerns
“First, do no harm.”
Hippocrates,Founder of Western Medicine
Traditional Glaucoma Surgery
Post-op complication rate at 2 years approaches 50%
U.S. Pivotal TrialSafety 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
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.
Determinants of Success and Concerns
Safety
Efficacy
Economics
0
25
50
75
100
50
72
0
25
50
75
100
48
66
% e
yes
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.
19.8
25.0
11.5
12.2 12.212.8 13.1
14.4
14.815.9
20.1
25.0
11.9
12.3 12.513.0 13.5
12.813.6
13.8
20.4
24.9
12.1
12.012.0 12.8 12.9
12.212.7 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
Mea
n IO
P (
mm
Hg)
Katz LJ. 2015 ASCRS, San Diego, CA.
OUS DATA
*1 cataract combo case converted to tube at 4M2 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. CONFIDENTIAL
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
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
Safety
Efficacy
Economics
Determinants of Success and Concerns
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
Glaucoma MedicationsPatient & System Costs
*Medicare Statistical Analytic File. Cataract patients with Glaucoma.
MIGS are cost effective
Economic AnalysisSurgeon 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
Economic Analysis Facility Reimbursement
* Medicare National Fee Schedule
2015 ASC
CPT Code 66984 0191T Total Increm.APC Group 0233 0673Stand alone procedure 960.64 $1,711.6366984 + 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 0673Stand alone procedure $1,751.53 $3,121.3466984 + 0191T $875.76 $3,121.34 $3,997.10 $2,243.57
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
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
iStent iStent Inject
iStent vs iStent Inject
Trabeculectomy Xen Procedure
XEN Procedure vs Trabeculectomy
Video: J. Batlle, MD
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.
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
Thank You
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