Glaucoma Surgery& The EX-PRESS® Device

Ike K. Ahmed, MDEXP11732SK

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.

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Disclosures• 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

• Speaker Honoraria (S)– New World Medical

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Glaucoma Surgical Options

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Ike K. Ahmed, MD5

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

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Ike K. Ahmed, MD

Overview of Current MIGS Procedures Commercialized and in Development

Commercialized• Trabectome

• ECP

Investigational*• iStent†

• Hydrus• ELT• Cypass• Aquesys

Schlemm’s Canal

Schlemm’s Canal

Suprachoroidal Space

Subconjunctival Space

6

Cycloablation

•Not FDA Approved•† Trademarks are the property of their respective owner. EXP11732SK

Subconjunctival Schlemm’s Canal Suprachoroidal IOP Drop More Potent Moderate Moderate

Risk Slightly More Lowest Risk Low

Ease of Use Easy to Perform+/- Gonio

Somewhat more DifficultRequires Gonio View

Easiest to Perform+/- Gonio

Potential Issues

?Bleb Issues?Episcleral Healing

?Hypotony

?Uncertainty of Placement?EVP Floor

?Distal Outflow Status

?Angle Bleeding?Variable IOP Drop

?Fibrosis in SCS

Other Features

FamiliarityAbility to modulate

postop healingPhysiologic?Titratable Potential

Ab-Interno MIGS Pathways

Ready for Primetime?EXP11732SK

Ike K. Ahmed, MD8

Patient Profiles: New ProceduresTrab-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

EXP11732SKSource: EX-PRESS® glaucoma filtration device package insert

Ike K. Ahmed, MD9

Glaucoma Surgery• Has traditionally been all about efficacy• Serious safety issues have promoted

evolutionary improvements

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Ike K. Ahmed, MD10

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 SafetyPredictabilityMaintain efficacy

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What Differentiates one Filter from the Next in My Experience

Intraoperative• AC shallowing• Tissue trauma• Bleeding• Length of procedure

Postoperative• Hypotony• Shallow/flat AC• Choroidals• Hyphema• Bleb leak• Bleb encapsulation• Bleb dysthesia• IOP control• Visual recovery• Postop interventions

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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.

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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

Ike K. Ahmed, MD13

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.

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Ike K. Ahmed, MD14

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

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.

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Ike K. Ahmed, MD15

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 20072) Good TJ, Kahook MY, AJO 2011

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Ike K. Ahmed, MD16

On-Label Indications (US)• Open angle glaucoma• Failed medical and laser/surgical therapy

• Anatomical factors– Scleral thickness– Angle anatomy

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Ike K. Ahmed, MD

EX-PRESS® Device Technique Pearls

• Anatomical landmarks• Scleral flap design and thickness• Device entry and angulation• Postoperative bleb management

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Scleral Spur

Sclera

Blue-zone

Cornea

Surgical Limbal Anatomy

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AC Entry

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

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Planning Scleral Flap Position & Size

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Identify Surgical Limbus

Planned entry point for EX-PRESS® DeviceEXP11732SK

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3.5x2.5 mm Scleral Flap

Ensure adequate flap overlap lateral and posterior to EX-PRESS® deviceto allow control of aqueous flow

1/2mm anterior gap to prevent excessive device compression

3.5

2.5

1.0

1.0

1.0

0.5

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Enter at anterior scleral spur/posterior blue zoneParallel to iris plane - aided by rotation of eye downwards

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Parallel to Iris

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Ike K. Ahmed, MD28

Postop Management• Bleb management• Laser suture lysis• Needling• Steroids

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Ike K. Ahmed, MD29

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

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