Glaucoma Surgery & The EX-PRESS ® Device

1. Glaucoma Surgery& The EX-PRESS® Device Ike K. Ahmed, MD EXP11732SK

2. EX-PRESS® Device Brief Statement CAUTION: Federal law restricts this device to sale by or on the order of a physician. INDICATION: The EX-PRESS® Glaucoma Filtration Device is intended to reduce intraocular pressure in glaucoma patients where medical and conventional surgical treatments have failed. GUIDANCE REGARDING THE SELECTION OF THE APPROPRIATE VERSION: Prior clinical studies were not designed to compare between the various versions of the EX-PRESS® Glaucoma Filtration Device. The selection of the appropriate version is according to the doctor's discretion. CONTRAINDICATIONS: The use of this device is contraindicated if one or more of the following conditions exist: · Presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis. · Pre-existing ocular or systemic pathology that, in the opinion of the surgeon, is likely to cause postoperative complications following implantation of the device. · Patients diagnosed with angle closure glaucoma. WARNINGS/PRECAUTIONS: · The surgeon should be familiar with the instructions for use. · The integrity of the package should be examined prior to use and the device should not be used if the package is damaged and sterility is compromised. · This device is for single use only. · MRI of the head is permitted, however not recommended, in the first two weeks post implantation. ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings, precautions, complications and adverse events. EXP11732SK EXP11706SK

3. Disclosures • Speaker Honoraria (S) • New World Medical • Consultant (+S) • Alcon • Allergan • Aquesys • AMO • Carl Zeiss • Clarity • Endooptiks • Eyelight • Glaukos • iScience • Ivantis • Pfizer • Transcend • Research Grants • Alcon® • Allergan • Aquesys • Carl Zeiss • iScience • Merck • Pfizer • SOLX • Visiogen Ike K. Ahmed EXP11732SK

4. Glaucoma Surgical Options EXP11732SK

5. Glaucoma Surgery Trends • Evolutionary improvements in trabeculectomy-like procedures • Canaloplasty • EX-PRESS® glaucoma filtration device • Increased use of long-tube shunts • Ahmed, Baerveldt glaucoma drainage devices • New field “Minimally Invasive Glaucoma Surgery (MIGS)” • Safe, quick procedures with modest IOP-lowering • Use at time of cataract surgery Ike K. Ahmed, MD EXP11732SK

6. Overview of Current MIGS Procedures Commercialized and in Development Commercialized Investigational* iStent† Hydrus ELT Cypass Aquesys • Trabectome • ECP Schlemm’s Canal Schlemm’s Canal Cycloablation Suprachoroidal Space Subconjunctival Space • Not FDA Approved • † Trademarks are the property of their respective owner. Ike K. Ahmed, MD EXP11732SK

7. Ab-Interno MIGS Pathways Ready for Primetime? EXP11732SK

8. Patient Profiles: New Procedures Trab-type Procedures EX-PRESS® Device Moderate-advanced disease Progressing normal pressure glaucoma Open Angle Low IOP target (i.e., <13mmHg) Intolerant to meds and failed SLT/ALT Ike K. Ahmed, MD Source: EX-PRESS® glaucoma filtration device package insert EXP11732SK

9. Glaucoma Surgery • Has traditionally been all about efficacy • Serious safety issues have promoted evolutionary improvements Ike K. Ahmed, MD EXP11732SK

10. Evolution of the Guarded Filtration Procedure • Wound healing strategies • Suture tension & laser suture lysis • Fornix-based flaps • Non-penetrating approaches • EX-PRESS® glaucoma filtration device Enhanced Safety Predictability Maintain efficacy Ike K. Ahmed, MD EXP11732SK

11. What Differentiates one Filter from the Next in My Experience Intraoperative Postoperative Hypotony Shallow/flat AC Choroidals Hyphema Bleb leak Bleb encapsulation Bleb dysthesia IOP control Visual recovery Postop interventions • AC shallowing • Tissue trauma • Bleeding • Length of procedure EXP11732SK

12. EX-PRESS® Glaucoma Filtration DeviceA Limbal Aqueous Device • Made of rigid 316LVM stainless steel – same as cardiac stents • < 3mm long • Internal lumen size – 50µm/200µm • Biocompatible • MRI of the head is permitted, however not recommended, in the first two weeks post implantation. Source: EX-PRESS® glaucoma filtration device package insert A Nyska, Y. Glovinsky, M. Belkin, and Y. Epstein. Biocompatibility of the EX-PRESS® miniature glaucoma drainage implant. J Glaucoma. 2003 Jun; 12(3):275-80 P-50 EXP11732SK

13. EX-PRESS® Device = Trabeculectomy • Potent IOP lowering1 • Requires scleral flap for additional flow control • Although not as critical • Requires functioning bleb, control of episcleral fibrosis • Conjunctival health a factor • Wound healing modulation 1) P. J. G. Maris, K Ishida, P A Netland. Comparison of Trabeculectomy with EX-PRESS® miniature Glaucoma Device Implanted Under Scleral Flap. J Glaucoma. 2007 Jan; 16:14-19. Ike K. Ahmed, MD EXP11732SK

14. EX-PRESS® Device > Trabeculectomy • No iridectomy required • Intraoperative maintenance of anterior chamber • Additional fluidic restriction (50um lumen) • Consistency • Quieter eyes in early postoperative period1 • Avoidance of intraoperative malignant glaucoma or choroidals1 • Reduction of early postoperative hypotony1 P. J. G. Maris, K Ishida, P A Netland. Comparison of Trabeculectomy with EX-PRESS® miniature Glaucoma Device Implanted Under Scleral Flap. J Glaucoma. 2007 Jan; 16:14-19. Ike K. Ahmed, MD EXP11732SK

15. EX-PRESS® Device Rationale & Transition • Hit low IOP target1,2 • Enhanced predictability1 • Minimize tissue disruption • Improved safety1 • Quieter postoperative course1 • Quicker visual recovery2 • Reduction of postop visits2 • Improved bleb morphology2 1) Maris PJ et al., J Glaucoma 2007 2) Good TJ, Kahook MY, AJO 2011 Ike K. Ahmed, MD EXP11732SK

16. On-Label Indications (US) • Open angle glaucoma • Failed medical and laser/surgical therapy • Anatomical factors • Scleral thickness • Angle anatomy Ike K. Ahmed, MD EXP11732SK

17. EX-PRESS® Device Technique Pearls • Anatomical landmarks • Scleral flap design and thickness • Device entry and angulation • Postoperative bleb management Ike K. Ahmed, MD EXP11732SK

18. SurgicalLimbal Anatomy Cornea Blue-zone Scleral Spur Sclera EXP11732SK

19. AC Entry Entry should be just at anterior aspect of scleral spur, at posterior aspect of the limbal blue zone. EXP11732SK

20. Planning Scleral Flap Position & Size EXP11732SK

21. Identify Surgical Limbus Planned entry point for EX-PRESS® Device EXP11732SK

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23. 3.5x2.5 mm Scleral Flap 1/2mm anterior gap to prevent excessive device compression 0.5 1.0 1.0 2.5 1.0 3.5 Ensure adequate flap overlap lateral and posterior to EX-PRESS® device to allow control of aqueous flow EXP11732SK

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25. Enter at anterior scleral spur/posterior blue zone Parallel to iris plane - aided by rotation of eye downwards EXP11732SK

26. Parallel to Iris EXP11732SK

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28. Postop Management • Bleb management • Laser suture lysis • Needling • Steroids Ike K. Ahmed, MD EXP11732SK

29. EX-PRESS® Glaucoma Filtration Device • An evolutionary improvement in trabeculectomy • Smaller incision, more standardized • Patient selection is much the same, although with improvement in safety and reproducibility, may be slightly broader (earlier intervention) • Retains high efficacy Ike K. Ahmed, MD EXP11732SK