1. Clinical Experience With the EX-PRESS ® Glaucoma Filtration Device Thomas W. Samuelson, M.D. Minnesota Eye Consultants Minneapolis EXP11748SK

2. EX-PRESS ® Device Brief Statement CAUTION: Federal (USA) 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. EXP11729SK EXP11748SK

4. Not always a disciple... ~ 2002 Participated in certification course Never did a case... “The EX-PRESS ® Device is Glaucoma Roulette” ~2007-2009 Willing to take another look 2009 - 2011 “Love the EX-PRESS ® Device!” (Note FDA approval Mar 02, JOG paper under scleral flap April 2005) EXP11748SK

5. Text Journal of Glaucoma, April 2005 EXP11748SK

6. EX-PRESS ® Glaucoma Filtration Device Procedure Minimally invasive Little if any shallowing of AC No need to release traction suture Less “open eye” risk: less SCH vulnerable VIDEO 1 EXP11748SK

7. EX-PRESS ® Device Guarded Filtration Procedure Minimally invasive... No risk of iris prolapse No risk of bleeding from ciliary body More wound control Less Induced Astigmatism More posterior flow EXP11748SK Source: EX-PRESS ® glaucoma filtration device package insert

8. EX-PRESS ® Device Guarded Filtration Procedure The same sclerostomy every time... EXP11748SK

9. EX-PRESS ® Guarded Filtration Procedure Standardized sclerostomy Not Standardized trabeculectomy! But... Safer, More elegant, More reproducible, Less invasive EXP11748SK

10. video two EXP11748SK

11. video three EXP11748SK

12. EX-PRESS® device does not have to get better results to be safer/more controlled and more elegant. A better experience for surgeon and, more importantly, for the patient Safety Improvements vs Efficacy Improvements EXP11748SK

15. Why Not Tubes? I love tubes... But not as my first surgery in most patients EXP11748SK

16. Postop Complications Tube 34% Trab 57% EXP11748SK

17. Incremental Improvements The EX-PRESS ® device is not the final answer in our quest for a standardized glaucoma operation It is a good next step Surgeons will make it better There is a learning curve for post op care Diffuse massage v focal massage Earlier suture lysis EXP11748SK

18. We must reduce the stagnation in glaucoma surgery innovation! EXP11748SK

19. What about the cost? Dear Patient... “I am sorry. Society can’t afford to improve on the glaucoma surgery of 1980’s” (antimetabolite filtering era) EXP11748SK

20. We spend a fortune meticulously documenting disease progression Visual fields, disc imaging, NFL imaging, angle imaging EXP11748SK

21. Our advances in imaging and in pharma are fabulous. But where is the investment in our surgical treatment options? Enough already, We need to move our surgical procedure forward! EXP11748SK

22. We have not invested in the surgical treatment of Glaucoma This is our time! For the first time we have industry R & D resources focused on glaucoma. Some very smart people looking to help us! If we ignore them, if we are satisfied with 1980s surgical methods, they will go elsewhere with their resources! EXP11748SK

23. Thank-you so much! EXP11748SK