10/27/20

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Justin Schweitzer, OD, FAAOVance Thompson Vision, Sioux Falls, South Dakota

Mastering the Management of MIGS

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Financial Disclosure – Justin Schweitzer, OD, FAAO

• Aerie – C/L• Alcon – C/L• Allergan – C/L• Bausch + Lomb – C/L• Ocular Therapeutix - C• EyePoint - C• Sight Sciences – C• Dompe - C

• Chief Medical Editor: Modern Optometry

• Sun - C• Equinox - I• Reichert - C• J&J – C/L• Glaukos - L• Horizon – C• Quidel - C

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WHYMIGS

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More than 90% of patients are nonadherent to their ocular medication

dosing regimens, and nearly 50%discontinue taking their medications

before 6 months1

Nordstrom BL. Persistence and adherence with topical glaucoma therapy. Am J Ophthalmol. 2005;140:598-596

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• Prospective, multicenter trial evaluating four ocular surface metrics 3 months post-stent implantation.

• n=47 eyes

• Other ocular health metrics improved as well:

− 49% longer time to tear break-up (FTBUT) (p<0.0001)

− Significantly reduced corneal/conjunctival staining (Oxford Schema) (p<0.0001)

− Trend toward less hyperemia (Efron Score)

OSD IMPROVEMENT IN IMPLANTED EYES1

Schw eitzer JA, Hauser W H, Ibach M , Baartm an B, Gollam udi SR,

Crothers AW , Linn JE, Berdahl JP. Prospective Interventional Cohort Study of Ocular Surface Disease Changes in Eyes After Trabecular M icro-Bypass Stent(s) Im plantation (iStent or iStentinject) w ith Phacoem ulsification. Ophthalm ol Ther. 2020 Aug 13.

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Dennis, P. (2011, October 10). Adverse Effects, Adherence and Cost–Benefits in Glaucoma Treatment. European Ophthalmic Review.

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Interventional Glaucoma

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Conservative Aggressive

MIGS

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Minimally or Micro Invasive Glaucoma Surgery(MIGS)

Procedures that have an ab-interno approach, are minimally traumatic, with at least modest efficacy, extremely high safety and rapid recovery .

Saheb H, Ahmed, IIK. Micro-invasive glaucoma surgery: current perspectives and future directions. Curr Opin Ophthalmol. 2012;23(2): 96-104.

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Collaborative Care in Glaucoma

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Cataract surgery alone……

may be the most common glaucoma surgery today.

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Case 1:

Ocular History• POHX: Primary Open Angle Glaucoma OS>OD• FHX:

• Mother – glaucoma, age-related macular degeneration

• Previous Treatment Regimen: None• Current Treatment Regimen:

• bimatoprost 0.01% qd OU

• IOP max• OD: 23 mm Hg• OS: 23 mm Hg

65-year-old, Caucasian female referred for a cataract evaluation and opinion on her glaucoma. She states her night-time VA is terrible, and she has started to struggle during the day as well.

Medical History• PMHX: Hyperlipidemia • All Medications: Fluoxetine, Atorvastatin • Allergies: Penicillin

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Ocular Exam

• Best corrected visual acuity (UCVA): 20/40 OD, 20/40 OS : BAT: 20/400 OU

• External exam: Normal appearance, symmetrical • Pupil exam: Equal, round, reactive to light and (-) APD • Slit-lamp exam

• Lids/Lashes: Clear, no debris, no signs of MGD OU• Conjunctiva: Clear, no injection OU• Cornea: Clear, no corneal staining OU, no pigment present OU• Anterior Chamber: Clear, no cells, no flare OU• Iris: Clear, no exfoliative material present, no transillumination defects OU• Lens: See Image/Slide• Goldmann Applanation Tonometry: 16 mm Hg OD, 17 mm Hg OS

• Central corneal thickness (CCT): 499 OD, 504 OS• Gonioscopy: Open to CB in all quadrants, no pigment in the TM, and

normal iris approach• Corneal Hysteresis: 9.4 mm Hg OD, 9.3 mm Hg OS

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OSCup-to-Disc: 0.50/0.50, Flat, Distinct

ODCup-to-Disc: 0.70/0.70, Deep cup, Distinct

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Minimally or Micro Invasive Glaucoma Surgery(MIGS)

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Schlemm’s Canal Type

Stents

iStent

iStent Inject

Hydrus

Dilation

OMNI

ABiC

Cutting

Kahook Dual Blade

OMNI/GATT

Ablation

Trabectome

Suprachoroidal Type

Stents

*Cypass

*iStent Supra

Subconjunctival Type

Stents

Xen

*InnFocusMicro

Cilioablative Type

External

Micropulse

Internal

ECP

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Ideal Patient Candidate

(iStent, iStent Inject, Hydrus)

Trabecular Meshwork Bypass Stents and Schlemm Canal Microstent

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Trabecular Microbypass Stent(iStent)

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Efficacy a Close 2nd

Ferguson, TJ, Berdahl, JP, Schweitzer JA. Clinical evaluation of a trabecular microbypassstent with phacoemulsification in patients with open-angle glaucoma and cataract.Clin Ophthalmol. 2016; 10: 1767-1773

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Trabecular Microbypass Stent(iStent Inject W)

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24 Months

Mean Unmedicated DIOPReduction

Change in Unmedicated DIOP

5.4 mmHg

Phaco alone

7.0 mmHg

iStent Inject Preop M24

24.8 mmHg

17.1 mmHg

Trabecular Microbypass Stent(iStent Inject W)

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Schlemm Canal Microstent(Hydrus)

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HORIZON Trial – 4 Year Update

Stent + Cataract (n=369) Cataract Only (n=187)

Baseline IOP (mm Hg)after washout

48 months mean IOP (mm Hg)

1 preoperative med2 to 4 preoperative med

25.5 (+/- 3.0) 25.4 (+/-2.9)

16.9 (+/-3.3) 17.3 (+/-3.4)

52.6%47.4%

54%46%

48 months medication free

65% 41%

48 months mean IOP (mm Hg)unmedicated

16.7 (+/-3.1) 17.2 (+/-3.2)

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AQUEOUS ANGIOGRAPHY VIDEO

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Ideal Patient Candidate

(Kahook Dual Blade, OMNI, ABiC)

Excisional Goniotomy and Ab Interno Trabeculotomy + Viscocanalostomy

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Excisional Goniotomy(Kahook Dual Blade)

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AS-OCT image after KDB treatment. Arrows indicate area of TM removal revealing minimal residual leaflets. (Source: Nate Radcliffe)

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Cataract Surgery plus Goniotomy 6-Month Outcomes

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p = 0.005p < 0.001

1 Day 1 Wk 1 Mo. 3 Mo. 6 Mo.

% of eyes ≥ 20% IOP reduction from baseline 50% 52.5% 49.3% 63.8% 58.3%

% of eyes using ≥ 1 fewer medications from baseline 60% 62.7% 59.7% 62.1% 61.7%

-4.6 mmHg from

baseline

-0.7 meds from

baseline

G reenw ood M D , Se ibold LK, Radcliffe NM , D ora ira j SK, A ref AA, Jim enez Rom án J, Lazcano-G om ez G , D arlington JK, Abdullah S, Jasek M C , Bah jri KA , Berdah l JP . G on iotom y w ith a sing le-use b lade: Short-te rm results. J C ataract Refract Surg 2017; 43: 1197-1201.

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Cataract Surgery plus Goniotomy 12-Month Outcomes

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1 Day 1 Wk 1 Mo. 3 Mo. 6 Mo. 12 Mo.

% of pts ≥ 20% IOP reduction from baseline 54.4% 57.8% 55.1% 67.4% 60.9% 57.7%

% of pts using ≥ 1 fewer medications from baseline 56.5% 64.4% 63.3% 60.5% 60.9% 63.5%

12 Mo.

% of eyes ≥ 20% IOP reduction from baseline 15.4%

% of eyes using ≥ 1 fewer medications from baseline 84.6%

12 Mo.

% of eyes ≥ 20% IOP reduction from baseline 100%

% of eyes using ≥ 1 fewer medications from baseline 42.3%

Patients (n=26) with baseline IOP ≤ 16.5 mmHg

Patients (n=26) with baseline IOP > 16.5 mmHg

D ora ira j SK, Se ibold LK, Radcliffe NM , A ref AA, Jim enez Rom án J, Lazcano-G om ez G , D arlington JK, M ansouri K, Berdah l JP . 12-M onth O utcom es of G oniotom y Perform ed Using the Kahook D ua l Blade C om bined w ith C ataract Surgery in Eyes w ith M edica lly Treated G laucom a. Adv Ther 2018; 35: 1460-1469.

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Ab-interno Trabeculotomy +Viscocanalostomy(OMNI)

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Transluminal Viscoelastic Delivery Trabeculotomy (ab interno)

• Treats all 3 points of resistance• Stand-alone or combined with CE• Titratable• 7.3mmHg mean IOP reduction from

23.7mmHg mean medicated baseline• Mean 12-month IOP of 15.7mmHg.

Sarkisian SR, Mathews, B, Ding K, Patel A, et al. 360 ab-interno trabeculotomy in refractoryPrimary open-angle glaucoma. Clin Ophthalmol. 2019;13:161-168.

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Results

before 1 week 1 month 3 m 6 m 1 year 18 m

All eyes IOP 21.42 13.73 -36%

15.00 -30%

14.00 -34.64%

13.88 -35.20%

13.85 -35.34%

12.82 -40.15%

drugs 2.92 0.08 -97.26%

0.17 -94.18%

0.41 -85.96%

0.85 -70.89%

1.47 -49.66%

1.73 -40.75%

OMNI alone

IOP 23.36 14.46 -38.10%

15.57 -33.35%

14.42 -38.27%

13.29 -43.11%

14.65 -37.29%

14.00 -40.07%

drugs 3.00 0.14 -95.33%

0.29 -90.33%

0.50 -83.33%

0.92 -69.33%

1.70 -43.33%

2.00 -33.33%

FacoOMNI

IOP 18.70 12.70 -32.09%

14.20 -24.06%

13.50 27.81%

14.75 -21.12%

12.71 -32.03%

11.40 -39.04%

drugs 2.80 0 -100%

0 -100%

0.30 -89.29%

0.75 -73.21%

1.14 -59.29%

1.40 -50%

OMNI in Open-Angle Glaucoma Treatment: An 18-month Follow-up. Grabaska-Liberek, I et al. Presented at ESCRS 2019

PhacoOMNI

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OMNI in Open-Angle Glaucoma Treatment: An 18-month Follow-up. Grabaska-Liberek, I et al. Presented at ESCRS 2019 Vienna

Results

Complications were limited to: IOP-spikes (9 eyes), hyphema (6 eyes) and

fibrin in the anterior chamber (5 cases) that resolved in the first week

after surgery

0

5

10

15

20

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IOP changes

all eyes OMNI alone facoOMNI

IOP

[m

mH

g]

0

0,5

1

1,5

2

2,5

3

3,5

Number of antiglaucoma drugs

all eyes OMNI alone facoOMNI

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Endocyclophotocoagulation (ECP)

TREATS INFLOWIt uses a laser endoscope containing three fiber groupings:

§ a light source (illum inate)

§ an im age guide (visualize)§ diode laser (treat)

Direct visualization Precise delivery to the ciliary processesno damage to the underlying ciliary body and surrounding tissue

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• IOP: 16 OD; 23 OS

• ONH Eval: 0.65/0.65 OD0.85/0.85 OS

• BCVA: 20/20 OD20/25 OS

• Pachymetry: 500 OD500 OS

Case 2Case 2:Ocular History

• POHX: Primary Open Angle Glaucoma OS>OD• FHX:

– Father – glaucoma, age-related macular degeneration• Previous Treatment Regimen: None• Current Treatment Regimen:

– bimatoprost 0.01% qd OU– dorzolamide/timolol bid OS– brimonidine 0.1% bid OS

• IOP max– OD: 25 mm Hg– OS: 25 mm Hg

64-year-old, Caucasian male with progressive glaucoma in his left eye.

Medical History• PMHX: Nothing of significance• All Medications: None • Allergies: Penicillin

• CH• OD: 10.5• OS: 7.5

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OS OD

47

z

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Ideal Patient Candidate

Subconjunctival Stent(XEN)

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Subconjunctival Stent(Xen)

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Xen 45 Gel Stent: US Pivotal Clinical Trial

76.3% of patients reported a mean diurnal IOP reduction of

> 20% from medicated baseline at 12 months

Baseline 12 month

Medicated IOP 25.1 (3.7) 15.9 (5.2)

Glaucoma Meds 3.5 (1.0) 1.7 (1.5)

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Hypotony 16 (24.6%)(IOP < 6 mmHg at any time)

Anterior chamber shallow 1 (1.5%)with peripheral irido-corneal touch

Anterior chamber fill 1 (1.5%)

Bleb Needling 21 (32.3%)

Postoperative Adverse Events

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Ab Externo

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Post-operative Considerationswith MIGS

2. IOP Spikes3. Hyphema

1. Stopping GLC Meds

4. Hypotony5. Establish New Baselines

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Stopping Glaucoma Medications

Severity of the Glaucoma

Preoperative IOP vs Postoperative IOPIOP progression was occurring

New baseline and hopefully off a med or meds

Likely on med in combo with MIGS

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PAS to Stents

YAG laser considered to open stent

US Pivotal iStent Inject Trial

1.8%@ 24 months

HORIZON Trial

13% @ 48 months

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Hyphema

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IOP Spikes

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Ocular Hypotony – Is it a Concern with MIGS?

Hypotony – An IOP below which the eye does not maintain its normal shape and may subsequently lose vision.

Definitions vary slightly – IOP< 5 or 6

Episcleral Venous Pressure and its role

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Establish New Baselines

IOP

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• Glaucoma is both a medical and surgical disease– Key to success is collaboration

• Trends in treatment aim to balance effectiveness and safety

• MIGS procedures allow for interventional glaucoma

In Conclusion...

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Thank You!

justin.schweitzer@vancethompsonvision.com

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