InnFocus MicroShunt™ France & Dominican Republic 2 Year Follow-up Richard K. Parrish, MD 1 Juan Batlle, MD 2 Professor Isabelle Riss 3 Bascom Palmer Eye Institute 1 Santo Domingo, Dominican Republic 2 Bordeaux, France 3 Presented in part at the AAO 2012 Annual Meeting, Chicago, Illinois

Dedicated to Francisco Fantes, MD

Outline  Surgical goal  Device requirements  Device design  Implantation video (Isabelle Riss)  Baseline characteristics  One year and two year results  Future direction

Goal Provide a safe, effective, easy to perform, cost effective surgical treatment for early-stage and trabeculectomy - stage patients with Primary Open Angle Glaucoma (POAG)

Device Requirements  Biomaterial to minimize foreign body reaction  Antiproliferative drug to minimize wound healing response  Establish surgical outflow path that lowers IOP ≤ 14 mmHg  Minimize immediate postoperative hypotony and unpredictable leakage around or through the device  Prevent tube blockage and migration

SIBS Material  Biomaterial that will likely minimize fibrovascular response in the eye Poly(styrene-block-isobutylene-block-styrene) “SIBS”  SIBS is stable and does not degrade in the body  No degradation reduces chronic inflammation and minimizes scar formation  SIBS is used in drug eluting coronary stents (TAXUS)  Twelve-year history of use in humans

SIBS and silicone rubber implanted sub-Tenon’s - 2 month Rabbit Studies at the Bascom Palmer Eye Institute Silicone Rubber Disk Silicone Rubber provokes neovascularization and pseudocapsule formation SIBS does not provoke neovascularization and pseudo capsule formation No Myofibroblasts SIBS Disk Courtesy: Edgar Espana, MD & A Carolina Acosta, MD

Encapsulation of Glaucoma Drainage Device (GDD) Silicone vs. SIBS subconjunctival implantation Rabbit after 3 months Silicone GDD plate Baerveldt, Ahmed SIBS GDD plate MIDI Arrow ~200  m capsule ~20  m capsule Conjunctiva Epithelium Encapsulation thickness reflects the polymer’s biocompatibility Courtesy: Sander Dubovy, MD

Evolution of Device Development Over 100 patients Five generations and five clinical trials

Device Design  Thin and soft to conform to the curvature of the eye.  Lumen large enough to prevent blockage with inflammatory debris, but sufficiently small and long to prevent hypotony.  Fin to prevent migration and leakage around the tube.  Current design:

Implanted InnFocus MicroShunt™

Surgeons in Phase 2 Studies  Professor Isabelle Riss  Bordeaux, France  Juan Batlle, MD  Santo Domingo, Dominican Republic

Implantation

Dominican Republic and France Baseline Characteristics Characteristics Both Groups Patients (n=)35 Age -Years (mean ± sd)61.6 ± 15.5 (Range 27-83) Ancestral Heritage22 mixed*/13 Caucasian Phakic/ Cataract/ Pseudophakic16/12/7 Baseline IOP (mmHg) (mean ± sd) 23.8 ± 5.3 (Range 18–38) Mean Visual Acuity (Snellen) 20/50 (LP-20/20) Glaucoma Diagnosis 35 POAG Glaucoma Meds/patient (mean ± sd) 2.8 ± 1.2 (1-5) *Afro-Carribean, Hispanic, Arawak Indian, Caucasian, or combination. Courtesy: Juan Batlle, Isabelle Riss, et al.

Dominican Republic and France Mean change in IOP with InnFocus MicroShunt™ Baseline IOP = 23.8 ± 5.3 mmHg Average IOP = 11.3 ± 3.2 mmHg AGIS zone of no progression of vision loss Courtesy: Juan Batlle, Isabelle Riss, et al.

Dominican Republic and France Qualified Success and IOP at 6, 12 and 27 Months Tube vs Trabeculectomy Published Criteria < 21 mm Hg with Rx 6 Months12 Months27 Months Success Rate 100% 91% IOP drop from Baseline 55% 50% IOP ≤ 21 mmHg 34/34, 100%24/24, 100%22/22 100% IOP ≤ 18 mmHg 34/34, 100%24/24, 100%20/22, 91% IOP ≤ 16 mmHg 30/34, 88%24/24, 100%19/22, 86% IOP ≤ 15 mmHg 27/34, 83%22/24, 92%18/22, 82% IOP ≤ 14 mmHg 27/34, 79%22/24, 92%18/22, 82% IOP ≤ 12 mmHg 25/34, 74%17/24, 71%14/22, 64% Courtesy: Juan Batlle, Isabelle Riss, et al.

Dominican Republic and France Reduction in Glaucoma Medication InnFocus MicroShunt Combined Procedures Both Procedures Patients (n=) Preoperative medications/patient (mean ± sd) 3.1 ± ± ± 0.9 Last follow-up medications /patient (mean ± sd) 0.4 ± ± ± 0.8 % Reduction from baseline87%100%89% Courtesy: Juan Batlle, Isabelle Riss, et al.

Dominican Republic and France Adverse Events – 2 Years Adverse Events InnFocus MicroShunt MicroShunt and Cataract surgery Both Procedures % of Eyes Patients (n=) n/a Corneal edema (n= edema present) Hypotony < 5 mmHg after Day Hypotony > 180 Days Shallow or flat anterior chamber (n=) Choroidal effusion or detachment Hyphema Elevated IOP requiring needling of bleb Tube obstruction by iris, blood, fibrin 1013 No sight-threatening long-term adverse events Courtesy: Juan Batlle, Isabelle Riss, et al.

Bleb Morphology Evolution – One Year Courtesy: Juan Batlle, et al.

Bleb Morphology Evolution – One Year Courtesy: Juan Batlle, et al.

Dominican Republic and France: Summary at 2 Years  100% and 91% qualified success rate at 1 and 2 years  IOP reduction of 55% from baseline to 11.3 ± 3.2 mmHg  82% of eyes with IOP ≤ 14 mmHg  89% reduction in glaucoma meds to 0.3 med/patient  89% of patients IOP controlled without glaucoma meds  Transient hypotony < 5 mmHg after Day 1 = 12%  all resolved spontaneously  No long-term sight-threatening adverse events  No endophthalmitis, chronic hypotony, choroidal hemorrhage, Courtesy: Juan Batlle, Isabelle Riss, et al.

Future Directions “Truth fears no trial” – Thomas Fuller, 1732  FDA authorized randomized clinical trial between trabeculectomy and InnFocus MicroShunt (Class 3 device) NCT www.clinicaltrials.gov  Principal Investigators  Howard Barnebey, MDBellevue, Washington  Louis Cantor, MDIndianapolis, Indiana Indiana University  Robert Feldman, MDHouston, Texas University of Texas  Mahmoud Khaimi, MDOklahoma City, Oklahoma University of Oklahoma  Richard Lehrer, MDAlliance, Ohio  Robert Noecker, MDFairfield, Connecticut  Adam Reynolds, MDEagle, Idaho  Kenneth Schwartz, MDChevy Chase, Maryland  Michael Stiles, MDOverland Park, Kansas  Steven Vold, MDFayetteville, Arkansas  Study Monitor  Paul F. Palmberg MD, PhDBascom Palmer Eye Institute, Miami, Florida