Postoperative Uncorrected Visual Acuity (UCVA) versus Preoperative Best Corrected Visual Acuity (BCVA) with the WaveLight Refractive Suite (Excimer EX500 and Femtosecond FS 200 Lasers) Arthur Cummings MD 1, Mathias Maus MD 2, Dan Durrie MD 3, Michael Gordon MD 4, Ravaughn Williams OD 5, James Gow MD 6 1 Wellington Eye Clinic, Dublin, Ireland; 2 Sehrkraft Augenzentrum Maus, Cologne, Germany; 3 Durrie Vision, Overland Park, KS, USA; 4 Gordon-Weiss-Schanzlin Vision Institute, San Diego, CA, USA; 5 Alcon Research Ltd., Fort Worth, TX, USA; 6 Alcon Research Ltd., Lake Forest, CA, USA Arthur Cummings is a consultant to Alcon. This study was funded by Alcon.

Background  The WaveLight ® Refractive Suite consists of: –A FS200 Femtosecond Laser for flap creation –An EX500 Excimer Laser for corneal tissue ablation that results in refractive error correction WaveLight® FS200 Femtosecond Laser WaveLight® EX500 Excimer Laser The WaveLight ® Refractive Suite Key Features: Precise circular and custom shape flap parameters Intracorneal ring segments Lamellar and penetrating keratoplasties Pupil registration and limbus detection Limbus relaxing incisions Corneal pockets with automatic pupil centration Arcuate keratotomy Simplified docking Enhanced graphic user interface detail Key Features: Enhanced repetition rate of 500Hz Advanced eye tracking technology Non-contact online pachymetry Highly customized, patient- specific treatments

Objective  To evaluate postoperative UCVA compared to preoperative BCVA with LASIK treatments for myopia using the WaveLight Refractive Suite  The hypothesis was that 1-month post-operative UCVA would not be inferior to pre-treatment BCVA within the pre-specified non-inferiority margin of 1 line (5 letters).

Methods This was an open-label, post-market, prospective, single arm study Subjects were treated with LASIK and were seen at 1 day, 1 month, 3 months and 6 months postoperative Typical ophthalmological assessments, including manifest refraction, uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA) and contrast sensitivity, were performed UCVA was tested with a 100% contrast ETDRS chart at 4 meters under photopic lighting conditions Manifest refraction was performed with the 100% contrast ETDRS chart at 4 meters under photopic lighting conditions BCVA was tested with the manifest refraction finding and the 100% contrast ETDRS chart at 4 meters under photopic lighting conditions

Study Subjects Age ≥18 years Preoperative myopia of up to D with or without astigmatism up to 6.0 D 104 subjects enrolled:  7 failed screening; 1 dropped out due to pregnancy  73 subjects in the Per Protocol Population

Statistical Analysis Noninferiority of postoperative binocular UCVA at 1 month was compared with preoperative binocular BCVA against a margin of 0.1 logMAR A two-sided 95% confidence interval was calculated for the mean difference in visual acuity values If the upper bound of the confidence interval was less than 0.1 logMAR, noninferiority was concluded After the non-inferiority hypothesis was confirmed, superiority was tested of 1 month, 3 months, and 6 months postoperative UCVA compared to preoperative BCVA

7 Safety Population (N=104) Per Protocol Population (n=73) Mean ± SD age, yr31.0 ± ± 5.63 Sex, n (%) Female55 (52.9)37 (50.7) Male49 (47.1)36 (49.3) Race, n (%) White85 (81.7)58 (79.5) Black3 (2.9)2 (2.7) Asian13 (12.5)10 (13.7) Other3 (2.9)3 (4.1) Subject Characteristics

Mean Manifest Refraction Spherical Equivalent (MRSE) Over Time in the Per Protocol Population Subjects’ postoperative (PO) mean MRSE improved immediately after surgery and remained stable at 1, 3 and 6 months.

Visual Acuity Outcomes Eye/Assessment Baseline, Mean LogMAR (±SD) 1 day, Mean LogMAR (±SD) 1 month Mean LogMAR (±SD) 3 months Mean LogMAR (±SD) 6 months Mean LogMAR (±SD) UCVA (OU)1.199 (0.6788) (0.1351) (0.1143) (0.1150) (0.1237) BCVA (OU) (0.1289) (0.1311) (0.1177) (0.1068) (0.1128) Mean logMAR UCVA was improved one day after surgery and remained stable thereafter Mean logMAR BCVA remained relatively unchanged after surgery

Comparing Binocular Postoperative UCVA to Preoperative BCVA in the Per Protocol Population Comparison Point Estimation (LS mean) Standard Error 95% Confidence Interval P-value Baseline [-0.103,-0.019] 1 Month [-0.163,-0.080] Difference [ ] Months [-0.171,-0.088] Difference [-0.108, ] Months [-0.175, ] Difference [-0.112, ] Postoperative UCVA was noninferior to preoperative BCVA at 1 month Binocular UCVA at postoperative 1, 3, and 6 months was significantly superior to preoperative BCVA

Conclusions  Subjects who underwent LASIK treatment with the WaveLight Refractive Suite for myopia and myopia with astigmatism had s ignificantly superior postoperative binocular UCVA at 1, 3, and 6 months compared to preoperative binocular BCVA