Preliminary U.S. FDA Outcomes of SMILE

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1 Preliminary U.S. FDA Outcomes of SMILE D. REX HAMILTON, MD, MS, FACS HEALTH SCIENCES CLINICAL PROFESSOR OF OPHTHALMOLOGY MEDICAL DIRECTOR, UCLA LASER REFRACTIVE CENTER STEIN EYE INSTITUTE, GEFFEN SCHOOL OF MEDICINE AT UCLA

2 In the past year, the presenter has received honoraria and travel support for educational lectures from: Abbott Medical Optics Alcon Laboratories Carl Zeiss Meditec

3 Many thanks to the following SMILE pioneers for providing slides/ content for this presentation: Dan Z. Reinstein, MD (London) Jon Dishler, MD (Denver)

4 SMILE Technique Is SMILE better than LASIK? Visual Outcomes Corneal Biomechanics Post-operative Dry Eye

5 SMILE Technique 1st cut: posterior surface of lenticule 2nd cut: anterior surface of lenticule (cap) 3rd cut: tunnel incision to corneal surface Delineation of anterior/posterior aspects of lenticule Removal of refractive lenticule *courtesy of Dan Reinstein, MD

6 SMILE History Developed in 2007 (Walter Sekundo, Rupal Shah) Only possible currently with VisuMax FS Laser (Zeiss) 350,000+ procedures worldwide 350 SMILE certified surgeons worldwide

7 Is SMILE Better than LASIK? Visual Outcomes Corneal Biomechanics Post-operative Dry Eye

8 SMILE vs. LASIK: Visual Outcomes FDA Clinical Trial: SMILE for Spherical Myopia Investigators

9 SMILE vs. LASIK: Visual Outcomes FDA Clinical Trial: SMILE for Spherical Myopia Demographics n = 216 Percent MEAN (SD) RANGE Gender Male Female Eyes Treated Age 34 yrs (8) 22 to 59 yrs MRSE D (1.81) to Sphere D (1.81) to Right Left Cylinder D (0.19) 0 to -0.50

10 SMILE vs. LASIK: Visual Outcomes FDA Clinical Trial: SMILE for Spherical Myopia UDVA Results: 95% 20/20 or better at 6 months (n=92)

11 SMILE vs. LASIK: Visual Outcomes FDA Clinical Trial: SMILE for Spherical Myopia Efficacy Results: 92% within +/- 0.5D of target MRSE at 6 months (n=92)

12 SMILE vs. LASIK: Visual Outcomes FDA Clinical Trial: SMILE for Spherical Myopia Safety Results: 98% gained or maintained CDVA at 6 months (n=92)

13 SMILE vs. LASIK: Visual Outcomes FDA Clinical Trial: SMILE for Myopic Astigmatism Investigators

14 SMILE vs. LASIK: Visual Outcomes FDA Clinical Trial: SMILE for Myopic Astigmatism Demographics n = 100 eyes 100 pts Percent MEAN RANGE Gender Age 33.9 yrs 24 to 58 yrs Male MRSE D to Female Cylinder D to -3.00

15 SMILE vs. LASIK: Visual Outcomes FDA Clinical Trial: SMILE for Myopic Astigmatism UDVA Results: 96% 20/25 or better at 3 months (n=69)

16 SMILE vs. LASIK: Visual Outcomes FDA Clinical Trial: SMILE for Myopic Astigmatism Efficacy Results: 97% within +/- 0.5D of target MRSE at 3 months (n=69)

17 SMILE vs. LASIK: Visual Outcomes FDA Clinical Trial: SMILE for Myopic Astigmatism Safety Results: 93% gained or maintained CDVA at 3 months (n=69)

18 SMILE vs. LASIK: Visual Outcomes MRSE Predictability at 7 days (Attempted vs. Achieved, N=100)

19 SMILE vs. LASIK: Visual Outcomes MRSE Predictability at 1 month (Attempted vs. Achieved, N=100)

20 SMILE vs. LASIK: Visual Outcomes MRSE Predictability at 3 months (Attempted vs. Achieved, N=69)

21 SMILE vs. LASIK: Visual Outcomes MRSE Predictability at 3 months (DRH LASIK, N=326)

22 Is SMILE Better than LASIK? Visual Outcomes Corneal Biomechanics Post-operative Dry Eye

23 SMILE vs. LASIK: Corneal Biomechanics Corneal tensile strength decrease with depth and from periphery to center courtesy John Marshall, PhD

24 SMILE vs. LASIK: Corneal Biomechanics (Side cut vs. Delamination) Femtosecond laser used to create LASIK flap, side cut only, delamination only Pressure increased from 15 to 15.5 mmhg and forward displacement measured using radial shearing speckle pattern interferometry (RSSPI) 90 μm 160 μm Group 1 LASIK flap LASIK flap Group 2 side cut only side cut only Group 3 delamination only delamination only

25 SMILE vs. LASIK: Corneal Biomechanics (Side cut vs. Delamination) Pressure increased from 15 to 15.5 mmhg and forward apical displacement measured using radial shearing speckle pattern interferometry (RSSPI) 160 µm 90 µm 9% 9% 5% LASIK Flap Side cut only Delamination only 32% 33% 5%

26 SMILE vs. LASIK: Corneal Biomechanics (Side cut vs. Delamination) Surface ablation and side cut cause vast majority of decrease in corneal tensile strength Delamination alone (SMILE) has minimal impact on corneal tensile strength Ablation

27 Is SMILE Better than LASIK? Visual Outcomes Corneal Biomechanics Post-operative Dry Eye

28 SMILE Cuts Fewer Anterior Nerves SMILE LASIK DZ Reinstein 2013

29 Corneal Sensation Measurement Cochet-Bonnet aesthisiometer Calibrated nylon filament for mechanical stimulation DZ Reinstein 2013

30 Corneal Sensation After SMILE 158 eyes 81 patients (26 male, 55 female) Age: mean 35 years (range: 19 to 66 years) Max myopia: mean D (range: to D) Cylinder: mean 0.73 D (range: 0 to 3.00 D) Corneal sensation mesaured pre-op and at 1 week, 1 month, 3 months, 6 months and 1 year following SMILE DZ Reinstein 2013

31 Comparison with SMILE 70 Mean Corneal Sensation (mm) LASIK SMILE Mean SEQ D Time Point (Months) DZ Reinstein 2013

32 Is SMILE Better than LASIK? Equivalent visual outcomes Less impact on corneal tensile strength Higher myopic corrections possible Shorter duration of post-operative dry eye revitalize refractive surgery market?

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