Company: Aeon Astron Europe B.V.Date: Apr-15-2013

Management of Glaucoma Surgery: Indian Perspective

OverviewBackground

Glaucoma overviewAre we ready to meet challenge

Surgery Forward – A “Cutting” edge solution?Trabeculectomy and its limitationsNew surgical trend and collagen implantScientific merits

Moving forward

Glaucoma Overview

Glaucoma is the second leading cause of blindness in India(Vijaya et al., 2006)

India est. to host 20% world glaucoma ppl by 2020 (Quigley & Broman, 2006)

Estimated approx. 12 million affected in 2010, and est. to reach 16 million in 2020 (Vijaya et al., 2006)

Are We Ready to Meet Challenge?

Many public & private hospital offer high quality care by well trained residents, BUT

More than 90% glaucoma remain undiagnosed contrary to 50-60% in developed countries (Ramakrishnan & Mona, 2011)

In 2001, est.12,000 ophthalmologists (i.e., 1/100,000 pt) with few glaucoma specialist (George etal., 2010)

Most ophthalmologists (70%) locate in urban cater only 23% ppl (Anderson & Douglas, 2003)

Medicine side lead to decreased QoL, poor compliance, along with life-long cost burden

Surgery Forward – The “Cutting” Edge Solution?

Suggested glaucoma surgery to overcome socio-economic burden with controlled IOP outcome (Ramakrishnan & Mona, 2011)

Ideal surgery isEasily performed by all surgeonsRequiring simple instrumentationMinimal complicationsReplicable technique with short

learning curveEconomic with long term success

outcome

Trabeculectomy – Golden Standard Option

Trabeculectomy remains the “gold standard” surgical option for reduction of IOP after failed maximal tolerated medication

However, episcleral fibrosis and subconjunctival scarring are the major causes of surgical failure

Limitation of MMC

MMC and 5-FU are the most commonly used adjunctive for the inhibition of fibroblast proliferation to prevent scarringChemo toxic and teratogenicBlebs is thinner with more irregular epithelium, breaks

in basement membrane, fewer goblet cells, and atrophic and avascular stroma

Blebitis or endophthalmitis commonly associated with thin, avascular, leaking blebs

Comprises > 90% atelocollagen and< 10% glycosaminoglycans

Highly porous structure with pore sizes ranges between 10~300µm

Good pliable strength to maintain the surgical space

Biocompatible and biodegradable

Ready for use

What is ologen® Collagen Matrix

What’s Mechanism of Action in Collagen vs. MMC?

Thin epithelium

Non-selective cell death results wound healing with thin avascular epithelium

Wound

bed

Cell death with reduced cell migration

Wound bed with spongy collagen scaffolds

Proliferation and migration encouraged

Porous scaffolds provide spacious binding sites for fibroblasts attachment to enable healthy tissue regeneration

Physiological wound healing

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Surgical technique remain unchanged. One LOOSE stitch over the scleral flap (keep 1-2 mm edge open) is recommended Simply place ologen® on the top of the scleral flap under conjunctiva

1 2 3

4 5 6

How is ologen® Collagen Matrix used?

Comparison Between ologen® CM and MMC

ologen® CM MMC

No clinical significant risk known

Non-toxic origin Non-teratogenic Natural wound healing

without MMC Physiologic, vascular bleb Comparable surgical success

rate as MMC Biocompatible Biodegradable Quick deployment without

preparation Save operation time

Teratogenic Toxic to ciliary body, corneal

endothelium Thinning of conjunctiva & bleb

wall Avascular bleb Increased risk to infection &

endophthalmitis Preparation required Prolong surgical time in

handling, application & disposal

Special facility required for handling (Hume hood)

Accreditations & Merits

CE marked, FDA 510k cleared, Canada approved

Over 150 scientific publications in academic conferences & journals

Discussed in 2 textbooksDiagnosis & management of

GlaucomaBasic concepts of glaucoma

Other ongoing studies

Research – 2-year Randomized Controlled Study

Prospective randomized controlled trial Postop. visit at 24±4 hours, 7±1 days, 2 weeks, and 1, 2, 3, 6,

12, 18 and 24 months Outcomes:

IOP target ≤ 21, ≤ 17, ≤ 15 mm Hg (complete or qualified success) Moorfields bleb grading system; SD-OCT (Topcon 3DOCT-1000) Number of glaucoma medications Postoperative adjunctive procedures Complications

Published in Eye Sep-16-2011

2-year Study of ologen® Collagen Matrix

MMC group OLO group P

3rd month14.7(3.9; 12.9-16.4)

44.5%15.0(3.8; 13.3-16.7)

45.1% 0.806

6th month14.7(4.3; 12.7-16.6)

44.5%14.1(3.1; 12.6-15.4)

48.4% 0.615

12th month15.0(3.0; 13.6-16.4)

43.4%15.2(2.8; 13.8-16.4)

44.3% 0.828

24th month16.0(2.9; 14.6-17.4)

39.6%16.5(2.1; 15.5-17.4)

39.5% 0.536

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Looking Forwards

Promote glaucoma awarenessImproved early diagnose rateSave patients before vision lossCollect clinical data to study socio-economic burdenWelcome opportunity to allies Vision Foundation

across Taiwan, Japan to initiate glaucoma care program