J. Colin, MD ASCRS 2008 Visual and Safety Performance of the AcrySof ® Phakic IOL in Global Clinical Trials Prof. Joseph Colin, MD Chef du Service d'Ophtalmologie - CHU Pellegrin Bordeaux, France (Financial Disclosure: Consultant, Alcon) EU Phase 3 Clinical Investigators J. Alió, MD (Alicante, Spain) J.L. Arné, MD (Toulouse, France) R. Bellucci, MD (Verona, Italy) B. Cochener MD (Brest, France) J. Colin, MD (Bordeaux, France) R.H. Gerl, MD (Ahaus, Germany) M. Knorz, MD (Mannheim, Germany) T. Kohnen, MD (Frankfurt, Germany) A. Marinho, MD/F. Vaz, MD (Porto, Portugal) Canada Phase 3 Clinical Investigators T. Demong, MD (Calgary, Alberta) S. Holland, MD (Vancouver, British Columbia) M. Pop, MD (Montreal, Quebec) T. Rabinovitch, MD (Downsview, Ontario) F. Roy, MD (Trois-Rivieres, Quebec) US Phase 2 Clinical Investigators  J. D. Horn, MD (Nashville, Tennessee )  R. Krueger, MD (Cleveland, Ohio)  S. S. Lane, MD (Stillwater, Minnesota)  W. A. Maxwell, MD, PhD (Fresno, California)  K. Solomon, MD (Charleston, South Carolina)

J. Colin, MD ASCRS 2008 Clinical Study Design Clinical Objective: Investigate safety & effectiveness Study design: Non-randomized, open label, single arm, multicenter clinical investigations Pooled analysis of global clinical studies 360 subjects included in total analysis European Phase 3 Clinical Study: 190 subjects Canadian Phase 3 Clinical Study: 120 subjects US Phase 2 Clinical Study: 50 subjects 3 to 5 year follow-up duration Results reported for 2 year follow-up visit (n=204) Optic6.0 mm Overall length12.5 mm to 14.0 mm Diopter Range -6.0 D to D L-Series AcrySof ® PIOL Not approved for general use. Anterior Chamber Angle-Supported Single-Piece IOL design Soft Acrylic (AcrySof ® IOL material) Monarch ® II IOL Delivery System Small incision size

J. Colin, MD ASCRS 2008 Study Criteria Main Inclusion Criteria Adults >18 years of age, with cap of 49 years of age for US and Canadian study Stable, moderate to high myopia (refraction within ±0.5 D at least 12 months prior to surgery) Able & willing to sign informed consent Main Exclusion Criteria Previous ocular surgery Glaucoma or family history of glaucoma Mesopic pupil size >7.0 mm Astigmatism >2.0 D Anterior chamber depth <3.2 mm Non-qualifying endothelial cell density per age criteria

J. Colin, MD ASCRS 2008 Postoperative Evaluation Endothelial Cell Density (ECD) & Morphology Adverse Events (AE) Maintenance of Best Spectacle-Corrected Visual Acuity (BSCVA) Uncorrected Distance Visual Acuity (UCVA) Best Spectacle-Corrected Distance Visual Acuity (BSCVA) Manifest Refraction Spherical Equivalent (MRSE) Predictability of Refraction

Endothelial Cell Density Mean Chronic % Change in ECD (Annualized) 2 years postop (from 6 months postop) Mean Acute % Change in ECD (Actual) 6 months postop (from preop) Minimal effects on Acute & Chronic ECD

Endothelial Cell Percent Hexagonality Preop vs. 2 year visit Endothelial Cell Coefficient of Variation Preop vs. 2 year visit Stable Cell 2 year visit Endothelial Cell Morphology

Cystoid Macular Edema00% Corneal Stromal Edema00% Corneal Haze10.3% Hyphema00% Hypopyon00% Intraocular Infection /Endophthalmitis00% Lens Dislocation00% Pupillary Block00% Retinal Detachment / Repair00% Raised IOP Requiring ≥1 month (Raised IOP Requiring Tx ≥1 month due to: Steroid Responders [8], Surgical Procedure [1], & Unknown Etiology [1]. One subject experienced 2 incidences. No persistent or ongoing cases at 2 year vist.) 102.8% Cataract Formation (Related to: Surgical procedure [3], & Concurrent ophthalmic disease [2]) 51.4% Adverse Events Cumulative through 2 years postoperative Out of 360 Subjects AE DescriptionRateIncidence

Synechia ( Goniosynechia) 61.7% Pupil Ovalization 0 0% Hospitalization for Raised IOP (On Operative Day) 5 1.4% Secondary Surgical Intervention (SSI)* *One subject experienced 2 incidences 92.5% IOL Replacement (Power exchange [2]) New Suturing (1) Prophylactic Treatment by Argon Laser (1) Preventive Iridotomy (1) Laser coagulation of retinal hole (1) IOL Removal (4) (Upside down placement [1], Patient dissatisfaction [2], Glare with 7.0 mm mesopic pupil size [1]) Adverse Events, cont’d. AE DescriptionRate Incidence Out of 360 Subjects

J. Colin, MD ASCRS 2008 Maintenance of BSCVA 2 year visit

UCVA 2 year visit BSCVA 2 year visit

Predictability of Refraction 2 years postop n=199 Mean Spherical Equivalent Preop to 2 year

J. Colin, MD ASCRS 2008 Conclusions: 2 year follow-up visit Safety Outcomes Minimal effects on ECD at 2 years postop BSCVA maintained No chronic inflammation or persistently raised IOP Low rate of adverse events observed Effectiveness Outcomes Excellent visual acuity High rate of predictability Refraction stable over time Clinical investigations ongoing