EX-PRESS® Device in Clinical Practice New York September, 2011 Marlene R. Moster MD Professor of Ophthalmology Thomas Jefferson School of Medicine Wills Eye Institute Philadelphia, Pa EXP11707SK

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. EXP11707SK

A move toward standardization EXP11707SK

Other Considerations Pseudophakes with temporal incisions and virgin superior conjunctiva Virgin eyes with deep chambers and open angles that have failed medications and SLT/ALT and need surgical glaucoma care Eyes that have had failed triples but with enough room temporal or nasal to put in the EX-PRESS® Device Patients who you would rather not put in a tube EXP11707SK

EX-PRESS® Device EXP11707SK

What is the difference? A trabeculectomy removes a piece of the cornea/trabecular meshwork which is followed by an iridectomy With the EX-PRESS® device, there is no removal of tissue, and an iridectomy is not necessary EXP11707SK

EX-PRESS ® Device Challenge 58 yo. Accountant IOP 24 in spite of maximum tolerated medical therapy and SLT laser myope pseudophakic EXP11707SK

80 y.o homemaker Had cataract surgery with a 3 piece IOL 19 years ago Vision always 20/20, Pseudoexfoliation IOP always normal, one drop of timolol Presented with decreased vision of 20/400 IOP of 40mmHg Lens sinking inferiorly but still in the correct plane EXP11707SK

OOPS! What can go wrong? EXP11707SK

OOPS! What can go wrong? EXP11707SK

Blew the thin area near the needle tract open with iris prolapse ! EXP11707SK

You always have options, which is why the comfort level with the EX-PRESS® device is so high EXP11707SK

In Summary The EX-PRESS® device is another good option in our surgical armamentarium Clinical studies have shown that it is safe and effective 1 If there is scarring, it can be needled One can always put in a larger tube down the road if it should fail 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 Jan; 16: EXP11707SK

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