UPDATE ON AVEDRO CROSSLINKING STUDIES
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- Bertram Lloyd
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1 UPDATE ON AVEDRO CROSSLINKING STUDIES Peter S. Hersh, M.D. Director, Cornea & Laser Eye Institute CLEI Center for Keratoconus Clinical Professor of Ophthalmology, Rutgers Medical School Visiting Researcher, Princeton University Dept Mechanical and Aerospace Engineering Avedro, Inc: Medical Monitor
2 U.S. MULTICENTER CXL TRIAL
3 AVEDRO CLINICAL TRIALS Treatment Groups U.S. multicenter trial of CXL started February 2008 Keratoconus (progressive) Corneal ectasia after refractive surgery Total KC treated = 293 Total Ectasia treated = 219
4 COLLAGEN CROSSLINKING Procedure: 30 Min, 3mW Protocol 9 mm epithelium removal Riboflavin drops every 2 minutes X 30 minutes 0.1% in 20% dextran 30 minutes UV exposure (365 nm UVA, 3mW/cm2) Total dose 5.4 J/cm 2
5 OPTICAL OUTCOMES
6 AVEDRO CLINICAL TRIALS U.S. Multicenter CXL Trial Primary Efficacy Criteria Mean change in Kmax of 1 diopter (D) between the CXL treatment group and the control group from baseline K max
7 AVEDRO CLINICAL TRIALS Multicenter Trial: 1 Yr K max Change Diopter Change KC (n=205) KC CXL Ectasia CXL Ectasia (n=175) KC Control Ectasia Control* Last observation carried forward (LOCF) used for control group Preop 1 Year Average Change Kmax = -1.6D Meets definition of success, P<0.0001
8 AVEDRO CLINICAL TRIALS Topography Indices (Pentacam): 1 Yr 3 out of 6 KC indices significantly improved 1 year after CXL Hersh PS, Greenstein SA, Fry KL. Corneal Topography Indices after Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia J Cat Refract Surg 2011;37: Preop 1 Yr
9 AVEDRO CLINICAL TRIALS Higher Order Aberrations: 1 Yr Higher Order Aberrations (RMS Wavefront Error in µm) * * * Greenstein SA, Fry KL, Hersh MJ, Hersh PS. Higher Order Aberrations after Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia J Cat Refract Surg 2012;38: Total HOA Spherical Aberration Coma Trefoil * Preoperatively 1 Year
10 VISION OUTCOMES
11 CXL RESULTS Visual Acuity: 1 Year (n=85) UCVA (logmar) /137 20/ Baseline 1 Month 3 Months 6 Months 12 Months BSCVA (logmar) / / Baseline 1 month 3 Months 6 Months 12 Months
12 ACCELERATED CROSSLINKING KXL-001,002
13 AVEDRO CROSSLINKING Accelerated Crosslinking Avedro platform with higher irradiance Standard CXL treatment is 3 mw UV for 30 minutes Accelerated crosslinking increases irradiance and decreases time Up to 45 mw Time down to 2 40
14 AVEDRO CLINICAL TRIALS Accelerated Crosslinking U.S. multicenter study 190 study eyes with keratoconus 2 concurrent studies for submission to FDA (KXL 001 & 002) 30 mw for 4 minutes Randomized to treatment vs placebo Inclusion criteria >12 yo Pachymetry >375 um Efficacy criterion Decrease in K max between treatment and control at 6 mo Peter Hersh Teaneck, NJ Daniel Durrie Overland Park, KS Leejee Suh New York, NY Sam Garg Irvine, CA Michael Gordon San Diego, CA Vance Thompson Sioux Falls, SD Michael Raizman Boston, MA Francis Price Indianapolis, IN Deepinder Dhaliwal Pittsburgh, PA Jose de la Cruz Chicago, IL Kraig Scot Bower Baltimore, MD J. Bradley Randleman Atlanta, GA Rajesh Rajpal McLean, VA Sonia Yoo Miami, FL
15 AVEDRO CLINICAL TRIALS Accelerated Crosslinking Milestone KXL-001 KXL-002 First Patient Enrolled August 2012 September 2012 No. of sites 5 6 Number of subjects enrolled Anticipate completion of enrollment Summer, 2014 Preliminary analysis of patients at 6 mo f/u 1.03 D greater flattenning in treatment group
16 ACCELERATED CROSSLINKING ACOS-KXL-001
17 AVEDRO CLINICAL TRIALS ACOS ACOS Society sponsored study Up to 4000 subjects (2000 KC, 2000 ectasia) at 100 sites 15 mw/cm 2 for 8 minutes Milestone 30 mw/cm 2 for 4 minutes Number 45 mw/cm 2 for 2 minutes 40 seconds First Subject Enrolled July 2012 Active Sites 83 Subjects Enrolled 990 Eyes Treated 1204
18 AVEDRO CLINICAL TRIALS ACOS: KC Preliminary Data
19 PULSED CROSSLINKING KXL-005
20 AVEDRO CLINICAL TRIALS Accelerated CXL: Pulsing Laboratory studies indicate 2 pathways of crosslinking Type 2: O 2 dependent Type 1: Ribo* Clinical goal: Increase efficacy crosslinking by enhancing O 2 availability Pulsed 1 sec on: 1 sec off UV light Allows O 2 replenishment 365 nm Early patients in U.S. trial treated Ribo* 1 O 2 Control with no dose CW Crosslinking Pulsed + O 2 Crosslinking
21 LASIK WITH ACCELERATED CROSSLINKING LASIK Xtra
22 AVEDRO CROSSLINKING Accelerated Crosslinking/LASIK Xtra - Avoid corneal biomechanical weakening and ectasia - Improve refractive accuracy and stability LASIK Soak 90 sec 0.25% ribo, rinse ribo Replace flap UV 30 mw x 3 min
23 AVEDRO CROSSLINKING International Experience Faruk Yilmaz, Turkey Results Published in JCRS A. John Kanellopoulos, Greece >5 Year Follow Up, Lower Enhancement Rate, Greater Stability in Hyperopes Howard Gimbel, Canada 1010 cases (542 LASIK Xtra, 468 PRK Xtra) Being Followed Minoru Tomita, Japan >24,000 Patients Treated Rohit Shetty, India 6 Month Follow Up with Demarcation Line Visible on OCT Robert Pinelli, Italy 40 Eyes with 6 Month Follow Up, +3D to -8D, Stable post-op MR
24 AVEDRO CROSSLINKING Accelerated Crosslinking/LASIK Xtra International studies underway U.S. clinical trial for high myopia planned for early 2015
25 PHOTOREFRACTIVE INTRASTROMAL CROSSLINKING PiXL
26 AVEDRO CROSSLINKING KXL II: PiXL Utilizes topo-guided KXLII system (Avedro) International studies underway U.S. clinical trial for topo guided crosslinking planned for early 2015
27 THANK YOU
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