One-year Results of a Schlemm s Canal Microstent for IOP Reduction in Open Angle Glaucoma

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1 One-year Results of a Schlemm s Canal Microstent for IOP Reduction in Open Angle Glaucoma Thomas W. Samuelson, MD Minnesota Eye Consultants On Behalf of the HYDRUS I Investigators 1

2 Disclosures This study was sponsored by Ivantis, Inc. Dr. Samuelson, Professor Tetz, and Professor Pfeiffer are investigators and consultants to Ivantis.

3 Micro Invasive Glaucoma Surgery Hypotensive medications and trabeculoplasty remain the most common treatment options for IOP reduction for patients with mild to moderate disease MIGS therapies for OAG are a possible therapeutic option that would reduce medication dependency Most MIGS approaches are being tested in conjunction with cataract surgery As cataract surgery is known to lower IOP, contribution of the device alone to IOP reduction is not well understood The multi-center study examines the effect of a Schlemm s canal microstent for IOP lowering effect

4 HYDRUS Microstent Ab interno Schlemm s canal microstent Inlet provides path through trabecular meshwork Open window design prevents obstruction of collectors in Schlemm s Windows Inlet For investigational use only in the United States 4

5 Mechanism of Action 3 clock hours of scaffolding provides access for aqueous to multiple collector channels Device design provides true dilation of Schlemm s canal without obstructing collectors Hydrus 8mm Implant For investigational use only in the United States 5

6 Handheld Injector For investigational use only in the United States 6

7 Surgical Technique For investigational use only in the United States 7

8 Screening and Informed Consent N=69 Pre Op Wash Out HYDRUS Surgery N=40 Hydrus + Phaco N=29 1, 3 & 6 Month Follow Up 12 Month Wash Out 12 Month Follow up HYDRUS I Study Schema 6 international centers Major inclusion criteria POAG/PXF glaucoma with characteristic optic nerve defect VF-MD no worse than -12 db IOP 26 mmhg (1-4 meds), mmhg (washed out) With or without cataract Endpoints Reduction in IOP compared to baseline using GAT Reduction in medications Intra- and post-operative safety 8

9 Participating Centers INVESTIGATOR Professor Dr. med Manfred Tetz Professor Dr. med N. Pfeiffer Dr. med Gabor Scharioth Professor Dr. med Salvatore Grisanti Professor Dr. med Clemens Vass Dr. Marina Ramirez Dr. Arturo Chayet Thomas Samuelson, MD CENTER ATK-Spreebogen Berlin, Germany Universitätsmedizin Mainz, Germany Aurelious Augenzentrum Recklinghausen, Germany Universitatsklinikum Lübeck, Germany University Medical Center Vienna, Austria Codet Vision Institute Tijuana, Mexico Medical Monitor 9

10 Demographics Hydrus Surgery Group N 40 Age 65.4 ± 10.9 Male 31% OD 53% Average MD (range) (0.57, ) POAG (PXF) 93% (11%) Pseudophakic 31% Pre Operative IOP, mean ± SD, mmhg 21.6 ± 4.4 Medication count, mean ± SD 1.7 ±

11 mmhg Results: IOP and Medications 30 HYDRUS Surgery Group Screening (40) 1 Day (40) month (40) 3 months (40) 6 months (38) Mean IOP Median IOP Mean Meds 12 months (37) 18 months (32)

12 Reduction in Medication Use HYDRUS Surgery Group N= % reduction in medication use along with 4.5 point median IOP drop N=22* 0 Screening 12 months Prostaglandin Analog Beta blocker CAI Alpha Agonist *prior to wash out

13 Adverse Events HYDRUS Surgery Group 1-12 Months N (%) Hypotony 0 Corneal Edema, abrasion or damage 1 (2.3%) IOP > 10 mm above baseline at any visit 2 (4.4%) Device Migration 0 Hyphema Layered (< 2mm), Transient (< 7days) Layered >2 mm 7 (15%) 1 (2.3%) Peripheral anterior synechia (PAS) 4 (9.5%) Visual loss (> 2 lines) 1 (2.3%)

14 Confirmatory Findings in Combo Group HYDRUS + Phaco Cohort Paired* Washed Out IOP Baseline 34% mean reduction 8.7 ± 4.3 mmhg P< Months *N=24

15 Ongoing Multicenter, Controlled Randomized Studies Utilizing HYDRUS Study Population Control Group Status HYDRUS II Mild to moderate POAG with cataract Phaco Only Enrollment Complete; In Follow up HYDRUS III Mild to moderate POAG with cataract Phaco + istent Enrolling HYDRUS IV Mild to moderate POAG with cataract (US IDE) Phaco Only Enrolling HYDRUS V Mild to moderate POAG with IOP > 23 on 1 med in phakic eyes 2 istents Enrolling

16 Summary The HYDRUS MIGS procedure is a safe method for reducing IOP using an ab interno surgical approach. No device migration or tissue erosion through 12 months Absence of serious complications such as hypotony, corneal decompensation, or endophthalmitis The most common post operative complication is transient hyphema Significant reductions in IOP and medication use were observed from baseline levels through 12 months when the device was used alone or in combination with cataract surgery Median pressures and medication free pressure distribution suggests stability from 1 to 18 months post operative Multiple randomized, controlled studies are underway both within and outside the United States