Conductive Keratoplasty for the Treatment of Presbyopic Emmetropes and Hyperopes to Improve Near Vision FDA Clinical Trial Protocol RCS-0110PRS 24 Month Data

CK Presbyopia FDA Clinical Trial Protocol RCS-011-PRS A Prospective Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of the ViewPoint CK System for the improvement in near vision in Presbyopic Emmetropes and Hyperopes utilizing the Conductive Keratoplasty (CK) Procedure

CK Presbyopia FDA Clinical Trial Protocol RCS-011-PRS 188 eyes of 150 subjects 61% female 39% male Mean age: 52.9 years old Age range: (43.7, 70.8) years old Mean Target: Target range: (-1.00, -2.25)

CK Presbyopia FDA Clinical Trial Protocol RCS-011-PRS 24 Month Data Treatment range (+1.00 to +2.25D) –16 and 24 spot patterns –Conventional Pressure Myopic target (-1.00 to -2.00D) –non-dominant eye for monovision

CK Presbyopia FDA Clinical Trial Protocol RCS-011-PRS 24 Month Data Safety –Preservation of BSCVA No eyes (0%) report loss of > 2 lines of BSCVA at 24 months –Induced Cylinder 97% have no clinically significant IC at 24 months –Adverse Events No Device or Procedure related Ocular AEs reported at 24M –Complications No Complications reported at 24M

CK Presbyopia FDA Clinical Trial Protocol RCS-011-PRS 24 Month Data Efficacy (Emmetropic Presbyopes) –Accuracy to 24 Months D = 53% D = 91% –UCVA-N 75% of eyes treated are J3 or better at 24 months 51% of eyes treated are J2 or better at 24 months

CK Presbyopia FDA Clinical Trial Protocol RCS-011-PRS 24 Month Data Subjective Response –Quality of Vision: 87% (Moderate, Marked or Extreme Improvement at 24 months) –Patient Satisfaction 79% (Satisfied or Very Satisfied at 24 months) –Quality of Depth Perception Pre-op: 94% (Good, Very Good or Excellent) 24 months: 90% (G, VG, E)

CK Presbyopia FDA Clinical Trial Protocol RCS-011-PRS 24 Month Data Key issue is STABILITY –MRSE over time –Average Keratometry over time –In the Eye treated for Near: UCVA-Near over time UCVA-Distance over time –Binocular UCVA-Distance and Near –Patient’s Subjective Perception over time

MRSE over time

Average K over time

Monocular UCVA-D and N

Binocular UCVA-D and N

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