WHY MIGS 7/26/18. MIGs in the BIGs A professional level understanding of MIGs. Human Cost of Glaucoma. Standard Treatment Options for Glaucoma

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1 Financial Disclosures for Mitch Ibach OD, FAAO MIGs in the BIGs A professional level understanding of MIGs Glaukos Alcon Equinox LLC. Mitch Ibach OD, FAAO Vance Thompson Vision Human Cost of Glaucoma WHY MIGS Glaucoma is the second leading cause of blindness worldwide Global estimates of glaucoma cases exceeded 60M in 2010 and are estimated to grow to 78M by Bilateral blindness is occurring at an alarming 7.5% of OAG cases globally, growing from 4.4M to 6M patients between 2010 and In the US, there are an estimated 2.2M cases of OAG, growing to more than 3M cases by 2020, with more than 88,000 of these patients going blind 3 1.Quigley HA. Number of people with glaucoma worldwide. Br J Ophthalmol March; 90(3): Congdon NG, De Jong PT, Klein BE et al.glaucoma as a cause of blindness in the United States. American Glaucoma Society Annual Meeting 2003; abstract. 3.Friedman DS, De Jong PT, Klein BE, et al. Glaucoma prevalence in the United States: results of a meta-analysis. American Glaucoma Society Annual Meeting 2003; Abstract. Standard Treatment Options for Glaucoma Standard Treatment Options Glaucoma Medications Laser Trabeculoplasty Surgery MIGs Trabeculectomy / Shunt Standard Treatment Options for Glaucoma Treatment Option Challenges Glaucoma Medications Ocular Surface Disease Side Effects Cost Compliance >90% of pt s are nonadherent, and nearly 50% stop taking glaucoma meds before 6 months 1 1. Nordstrom BL. Persistence and adherence with topical glaucoma therapy. Am J Ophthalmol. 2005;140:

2 7/26/18 Glaucoma medications and OSD Standard Treatment Options for Glaucoma OSDI Score in Glaucoma Treatment Option Challenges Laser Trabeculoplasty Safety 12.9 Efficacy 10 IOP spikes 5 0 OSDI Score drop 2 drops 3 drops Fechtner, R., Godfrey, D., Budenz, D., Stewart, J., & Stewart, W. (2010, June). Prevalence of Ocular Surface Complaints in Patients With Glaucoma Using Topical Intraocular PressureLowering Medications. Cornea, 29(6), Standard Treatment Options for Glaucoma Treatment Option Challenges Incisional Glaucoma Surgery Risks associated with surgery and healing Failure rates Costs to patients/system TVT à 5 year data Tube Trab IOP # of Meds Failure Rate 30% 47% Complications- 39% 60% Complicaitons- 22% 27% Reoperation 9% 29% Post op Surgical Gedde, S. J., Schiffman, J. C., Feuer, W. J., Herndon, L. W., Brandt, J. D., Budenz, D. L., Tube versus Trabeculectomy Study Group. (2012). Treatment outcomes in the Tube Versus Trabeculectomy (TVT) study after five years of follow-up. American journal of ophthalmology, 153(5), e2. doi: /j.ajo Minimally 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): Phakic (Cataract) or Pseudophakic 2

3 7/26/18 Phakic (Cataract) or Pseudophakic MIGS Devices Reduction in Intraocular Pressure after Cataract Extraction: The Ocular Hypertension Treatment Study. (2012, September). Ophthalmology, 119(9), Trabecular Meshwork / Schlemm s Canal Suprachoroidal Subconjunctival Supraciliary Stents Dilation istent istent Inject* Hydrus* GATT Kahook Trabectome Cypass Visco360 Dual istent Supra* ABiC Blade (Ab-interno Canaloplasty) Titanium TM bypass stent Cutting Ablation istent Xen InnFocus* Creates a patent opening in the trabecular meshwork, the source of 75% of resistance Restores natural physiological outflow The natural episcleral back pressure of 8 to 11 mm Hg, minimizes the risk of hypotony 3

4 istent Pivotal US IDE Trial Cataract Surgery + 1 G1 stent Prospective, randomized, multi-centered study Cataract and POAG patients who underwent istent + cataract surgery vs. cataract surgery (CE) alone 290 eyes at 29 sites Efficacy endpoints 240 randomized eyes with cataract and mild-tomoderate OAG (1:1 randomization) 50 additional non-randomized subjects for safety Primary: IOP 21 mm Hg without medications at month 12 Secondary: IOP reduction 20% without medications at month 12 Overall safety profile comparable to cataract 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: Pseudophakic G1 patients istent inject Head (resides in Schlemm s Canal) Neck (Trabecular Meshwork) Flange (in Anterior Chamber) 0.3 mm dia 0.4 mm Two stents pre-loaded per injector 21 istent inject MIGS Study Group (Data presented at AGS 2017) Hydrus Microstent 2 stents implanted in 57 subjects (phakic and pseudophakic) All patients were on 1 pre-op medication Patients were washed off medications Preop IOP medicated 19.4 IOP after washout 24.4 Postoperatively mean IOP At or below subject requiring medication 4

5 Hydrus Microstent Horizon Trial Kahook Dual Blade vs Trabectome 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 77.2% 57.8% Lowered IOP 20% Hydrus + CEX CEX 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 78% 48% Medication free Hydrus + CEX CEX alone Harasymowycz PJ. Canal stenting: Into Schlemm s and beyond. Presented at AAO Subspecialty Days; Nov , 2017; New Orleans. Combined Phaco+KDB Cohort Combined Phaco+KDB Cohort Mean IOP Preoperative N= ± 5.2 Day 1 (1-3 days) N= ± 3.9 Week 1 (4-14 days) N= ± 4.8 Month 1 (15-59 days) N= ± 3.4 Month 3 ( days) N= ± 2.6 Month 6 ( days) N= ± 2.3 Month 12 ( days) N= ± 3.4 IOP Medications Mean Difference Reference -4.1* -4.0* -3.8* -4.8* -4.7* -5.0* IOP Percent Change Reference 24% 23% 22% 28% 27% 29% Mean Meds 1.6± ± ± ± ± ± ± 0.8 Mean Difference Reference -1.2* -0.9* -0.9* -0.7* -0.7* -1.0* Meds Percent Change Reference 75% 56% 56% 44% 44% 63% * P<0.001 when compared to preoperative measurement. Mixed Models (α of 0.05) was used for analysis with adjustment for multiple comparisons: Bonferroni Significant at an alpha Two cases of reoperation for IOP control was excluded from tables and graphs without any significant impact on the results. 29% reduction in IOP at month 12 with baseline IOP below 18mmHg 27 Intraoperative N=122 KDB Survey AE Day 1 (1-3 days) N=108 Week 1 (4-14 days) N=104 Month 1 (15-59 days) N=116 Month 3 ( days) N=91 Month 6 ( days) N=92 Month 12 ( days) N=68 Blood Reflux/Retained Heme 38.5% 10.2% 3.8% Difficulty Removing TM 1.6% Cyclodialysis Cleft 0.8% Descemet Tear 0.8% Iridodialysis 0.8% Irritation - 0.9% - 0.9% Hypotony - 0.9% 0.8% Corneal Edema - 0.9% 1.0% PAS % Reoperation for high IOP % - 1.1% - - IOP Spike % 0.9% Inflammation - 0.9% 0.9% Choroidal detachment % Hazy vision % Capsular opacification % 1.1% - - CME % - - Pain % 1.5% Floaters % - - Glare %

6 Canaloplasty- Visco360 & ABiC Procedure Steps: 1. Trabeculotomy/Goniotomy Omni 2. Catheter/Micro-catheter Schlemms 3. Visco-dilation Khaimi, M. (2015, November). Ab Interno Canaloplasty. Glaucoma Today, Suprachoroidal Space istent SUPRA Product Description Lumen Size: mm Outer Diameter: mm Length: 4 mm Length of Sleeve: 1.1 mm US IDE Trial Under Way 34 CyPass Micro-Stent Compass Trial- 2 year data Vold, S., Ahmed, I., Craven, R., Mattox, C., Stamper, R., Packer, M., & Brown, R. (2016, October). Two-Year COMPASS Trial Results: Supraciliary Microstenting with Phacoemulsification in Patients with Open-Angle Glaucoma and Cataracts. Ophthalmology, 123(10),

7 DUETTE Study 65 eyes with medicated IOP greater than 21 at baseline pseudophakic eyes Baseline 12 Months IOP / /-5.5 Medications 2.2 +/ /-1.3 Adverse Events: IOP > 30 beyond 1 month (11%), transient hyphema (6%) Xen Xen 45 Gel Stent: US Pivotal Clinical Trial Visits IOP and Medications Baseline 12 Month Mean Medicated IOP 25.1 (3.7) Glaucoma Meds 3.5 (1.0) IOP 15.9 (5.2) Glaucoma Meds 1.7 (1.5) 76.3% of patients reported a mean diurnal IOP reduction of > 20% from medicated baseline at 12 months FDA approves Xen gel stent for glaucoma (2016, November 28). In American Academy of Ophthalmology. Postoperative Adverse Events 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%) 7

8 7/26/18 How Do You Decide? Minimally Invasive Safety First When we want to maximize safety Canal When we want to maximize quick visual recovery Canal When we need greater efficacy, and are willing to take a bit more risk, but still want greater safety than transcleral Supraciliary 1. IOP Spikes 2. Microhyphema 3. Hypotony- Can it happen? 4. New baseline IOP Quick progressing glaucoma and a need for low IOP Transcleral, Trab, or Tube Courtesy of Dr. Tom Samuelson MIGS Landscape is a view worth watching Thank You! Questions 8