Conductive Keratoplasty for the Correction of Low to Moderate Hyperopia: U.S. Clinical Trial 12-Month Results

U.S. Clinical Investigators  Penny Asbell, MD  Stephen Brint, MD  William Culbertson, MD  Jonathan Davidorf, MD  Elizabeth Davis, MD  Dan Durrie, MD  R. Bruce Grene, MD  Peter Hersh, MD  David Hardten, MD  Vera Kowal, MD  Richard Lindstrom, MD  Robert Maloney, MD  Edward Manche, MD  Roger Meyer, MD  Thomas Samuleson, MD  Timothy Schneider, MD  Kaz Soong, MD  Alan Sugar, MD Marguerite McDonald, MD – Medical Monitor

Treats hyperopia, astigmatism, presbyopia and over/under LASIK corrections Induces permanent collagen shrinkage Creates a column of treatment Utilizes cornea’s conductive properties Conductive Keratoplasty Features

ViewPoint ™ CK System

The Keratoplast™ tip (90 µm wide, 450 µm long) with coated stop at the distal end (shown next to a 7-0 suture)

Conductive Keratoplasty (CK)

US FDA Phase III Study 400 Patients –Spherical hyperopia 0.75 D to 3.00 D –< 0.75 D of cylinder –No prior refractive surgery –No significant ocular/physical history 24 Month Follow-Up Study Objective

Demographics Number of Patients Number of Eyes Mean Age Range 55 +/- 5.4 years (40 to 74) Mean Preoperative MRSE Median MRSE / D D Mean Preoperative CRSE / D

Simple Procedure Instill topical anesthesia Insert lid speculum (return path for energy) Mark eye Apply treatment Total time less than 5 minutes

Conductive Keratoplasty (CK)

6 mm OZ Number, Location, and Sequence of Treatment Spots Sequence mm OZ 7 mm OZ 32 spots (2.375 to 3.00 D) 24 spots (1.75 to 2.25 D) 16 spots (1.00 to D) 8 spots (0.75 to D)

Slit Lamp Photo 1 Hour After CK Small leucoma Visible striae

Postoperative UCVA Over Time

Accuracy of Achieved Refraction

MRSE Stability through 12 Months Patients with Consecutive Visits Mean Change 0.25 D (0.50) 0.11 D (0.41) 0.11 D (0.35) in MRSE Conf. Interval 0.19, , , 0.15

Safety Variables 12 Months N=383  2 lines lost BSCVA 2%  > 2 lines lost BSCVA 0.0%  BSCVA Worse than 20/40 0.0%  Increase >2.00 D Cylinder 0.3%  Pre-Op  20/20, Post-op  20/25 0.0%

Induced Cylinder >2.00 D CK vs. Non-Contact LTK Post-op MonthLTK 1 CK 2 1 Month3.4%3.0% 3 Months1.4%2.0% 6 Months0.9%1.0% 12 Months0.2%0.3% 1 Sunrise LTK FDA Clinical Study, 2 Conductive Keratoplasty 12-Month FDA Clinical Study Results.

Summary Efficacy Variables FDA Guideline 6 Mos. (N = 352) 12 Mos. (N = 318) UCVA < 20/2050%45%56% UCVA < 20/25 Not Stipulated 64%75% UCVA < 20/4085%90%92% MRSE %61%63% MRSE %88%89% Data from patients with single treatment. No retreatments included.

Conductive Keratoplasty: Case Study Preoperative –50 year old –Female –African American –Good health –No ocular history –6 mm pachymetry: 556 µm –IOP: 15 mm Hg Preoperative –UCVA D : 20/125 –UCVA N : J12 –Manifest RX: – 0.75 X 130 –Cycloplegic RX: – 0.25 X 130 –BSCVA D : 20/25

Operative –Instilled three drops topical anesthesia –Inserted lid speculum –Applied 32 treatment spots –Removed lid speculum –Instilled NSAID and antibiotic –Immediate K-Readings: 180 X Conductive Keratoplasty: Case Study

1 Day Post-Operative –UCVA D : 20/32 –UCVA N : J7 –Manifest RX: – 0.50 X 120 –BSCVA D : 20/20 –BSCVA N : J2 –Slit Lamp: small epithelial defects Conductive Keratoplasty: Case Study

1 Month Post-Operative –UCVA D : 20/20 –UCVA N : J2 –Manifest RX: – 0.75 X 125 –BSCVA D : 20/20 –BSCVA N : J1 –Slit Lamp Exam: WNL Conductive Keratoplasty: Case Study

3 Month Post-Operative –UCVA D : 20/32 –UCVA N : J2 –Manifest RX: plano – 1.00 X 125 –BSCVA D : 20/16 –BSCVA N : J1 –Slit Lamp Exam: WNL Conductive Keratoplasty: Case Study

6 Month Post-Operative –UCVA D : 20/30 –UCVA N : J2 –Manifest RX: – 0.75 X 125 –BSCVA D : 20/25 –BSCVA N : J1 –Slit Lamp Exam: WNL Conductive Keratoplasty: Case Study

12 Month Post-Operative –UCVA D : 20/20 –UCVA N : J2 –Manifest RX: – 0.25 X 110 –BSCVA D : 20/16 –BSCVA N : J1 –Slit Lamp Exam: WNL Conductive Keratoplasty : Case Study

Preoperative –50 year oldFemale –UCVA D : 20/125 –UCVA N : J12 –Manifest RX: – 0.75 X 130 –BSCVA D : 20/25 12 Months Post-op –UCVA D : 20/20 –UCVA N : J2 –Manifest RX: – 0.25 X 110 –BSCVA D : 20/16 No retreatment. Spherical correction only

Corneal Topography: Case Study Preoperative 12 month Post-op

Confocal View Of CK Folds Between Treatment Spots Sabry, McDonald, Klyce

Confocal View Of CK Deep CK Treatment With Healthy Endothelium Sabry, McDonald & Klyce

Cylindrical Footprint of CK

Summary of Phase III Study Highly effectiveHighly effective – comparable to H-LASIK Stability at 6 monthsStability at 6 months Safe – low rate induced cylinderSafe – low rate induced cylinder Penetration depth confirmed by histology, confocal microscopyPenetration depth confirmed by histology, confocal microscopy

Summary of Phase III Study Topography shows central corneal steepening with mid-peripheral flatteningTopography shows central corneal steepening with mid-peripheral flattening Visual axis sparedVisual axis spared Multicenter study continues for two yearsMulticenter study continues for two years