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The Present and Future of CXL
Rajesh K. Rajpal, MD
Chief Medical Officer
Financial Disclosures
• Avedro, Inc: Employee, Investigator, Shareholder
United States FDA Approval
Avedro, Inc. received approval from the U.S. Food and
Drug Administration (FDA) for Photrexa Viscous
(riboflavin 5’-phosphate in 20% dextran ophthalmic
solution) 0.146%, Photrexa (riboflavin 5’-phosphate
ophthalmic solution) 0.146%, and the KXL system for
corneal cross-linking for the treatment of progressive
keratoconus on April 15th 2016.
Photrexa Viscous, Photrexa and the KXL System
are the first and only FDA-approved therapeutic
treatment for progressive keratoconus
FDA Approved Indication
INDICATION AND USAGE
Photrexa Viscous and Photrexa are photoenhancers
indicated for use with the KXL System in corneal collagen
cross-linking for the treatment of progressive keratoconus.
CONTRAINDICATIONS
None
WARNINGS AND PRECAUTIONS
Ulcerative keratitis can occur. Monitor for resolution of
epithelial defects.
ADVERSE REACTIONS
The most common ocular adverse reactions in any CXL-
treated eye were corneal opacity (haze), punctate
keratitis, corneal striae, corneal epithelium defect, eye
pain, reduced visual acuity, and blurred vision.
5
Brian Roberts – CFO/COO
Steve Blinn – CCO
Rajesh K. Rajpal, MD – CMO
Marc Friedman, PhD – CSO
Senior Management Board of Directors
Robert J. Palmisano
Joe Mandato, PhD
Gil Kliman, MD
Jonathan Silverstein
Avedro Senior Management Team
755 Avedro devices sold worldwide
78 countries with Avedro devices
Avedro’s Approved Countries
Commercial Infrastructure for Growth
SALES & DISTRIBUTION
United States
• 10 member direct sales team
• 6 member direct service team
Outside the United States
• 66 distributors
• 200 sales and service reps
INSTALLED BASE
PiXL …
The Future of Refractive CXL
PiXL: Photorefractive Intrastromal Cross-linking
UVA patterning is applied
with the Mosaic System
to the center of the
riboflavin-soaked cornea
for myopia correction
PiXL Myopia
Treatment
Goal: induce focal stiffening in the cross-linked regions,
resulting in “bulging” of the cornea in untreated regions in
response to the normal intraocular pressure
Prospective Epi-Off Clinical Trial
Ruhr University, Bochum, Germany
A prospective evaluation of the safety and efficacy of the
KXL II system for photorefractive intrastromal cross-
linking (PiXL) for the treatment of Myopia
40 Eyes with Myopia
Follow-up at 1, 3, 6 and 12 Months
Evaluations to include:
• UCVA
• BSCVA
• Autorefraction
• Manifest refraction
• Slit lamp examination
• Intraocular Pressure
Measurement
• Anterior Segment OCT
• Pentacam measurements
• Aberrometry
• Specular Microscopy
Professor H. Burkhard Dick
Matthias Elling, MD
Ruhr University
Bochum, Germany
Initial 12 month results demonstrate the stability of the procedure from 3
months, confirming the feasibility of PiXL as a refractive treatment
Prospective Clinical Trial: Stability
Ruhr University, Bochum, Germany
Potential to reduce
recovery time and
speed stabilization
by avoiding
epithelial removal.
12 Month Stability (n=9)
Transepithelial PiXL Pilot Study
Dr. Julian Theng and Dr Lim Wee Kiak Eagle Eye Ctr. Singapore
Demographic:
14 myopic eyes (1.62 ± 0.6D)
Post-op checks:
Objective
• Safety – BCVA, ECC, Slit lamp evaluation
• Efficacy – UCVA, manifest Rx, Contrast Sensitivity, Corneal topography
Subjective
• Questionnaire
Sphere Cylinder Treatment Zone
UV
Energy
Treatment Time
-0.50 to -0.75D < -0.50D 4.5mm 10J 11 min 11 sec
-1.00 to -1.50D < -0.50D 4.5mm 15J 16 min 39 sec
Dr. Julian Theng
Medical Director
Eagle Eye Ctr.
Singapore
Transepithelial PiXL Pilot Study
Dr. Julian Theng and Dr Lim Wee Kiak Eagle Eye Ctr. Singapore
Mean gain in VA: 0.35 log unit (3.5 snellen lines) Average MRSE reduction: 0.80 ± 0.45D
* MRSE – Manifest Refraction Spherical Equivalent
Upcoming Transepithelial PiXL Studies
20+ Healthy Myopic Eyes Per Site
Intended correction:
-0.75 to -2.0D sphere, 0 to 0.75 D cyl
No prior corneal surgery
Investigator-Initiated Pilot Clinical Trials of Transepithelial PiXL
with Supplemental Oxygen for Treatment of Low Myopia
Principal Investigators:
Prof. H. Burkhard Dick
Ruhr University,
Bochum, Germany
Prof. François Malecaze
Hôpital Purpan
Toulouse, France
Prof. Anders Behndig
Umea University Hospital
Umeå, Sweden
Avedro Booth 1601

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OPHTHALMOLOGY INNOVATION SHOWCASE - Avedro

  • 1. The Present and Future of CXL Rajesh K. Rajpal, MD Chief Medical Officer
  • 2. Financial Disclosures • Avedro, Inc: Employee, Investigator, Shareholder
  • 3. United States FDA Approval Avedro, Inc. received approval from the U.S. Food and Drug Administration (FDA) for Photrexa Viscous (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) 0.146%, Photrexa (riboflavin 5’-phosphate ophthalmic solution) 0.146%, and the KXL system for corneal cross-linking for the treatment of progressive keratoconus on April 15th 2016. Photrexa Viscous, Photrexa and the KXL System are the first and only FDA-approved therapeutic treatment for progressive keratoconus
  • 4. FDA Approved Indication INDICATION AND USAGE Photrexa Viscous and Photrexa are photoenhancers indicated for use with the KXL System in corneal collagen cross-linking for the treatment of progressive keratoconus. CONTRAINDICATIONS None WARNINGS AND PRECAUTIONS Ulcerative keratitis can occur. Monitor for resolution of epithelial defects. ADVERSE REACTIONS The most common ocular adverse reactions in any CXL- treated eye were corneal opacity (haze), punctate keratitis, corneal striae, corneal epithelium defect, eye pain, reduced visual acuity, and blurred vision.
  • 5. 5 Brian Roberts – CFO/COO Steve Blinn – CCO Rajesh K. Rajpal, MD – CMO Marc Friedman, PhD – CSO Senior Management Board of Directors Robert J. Palmisano Joe Mandato, PhD Gil Kliman, MD Jonathan Silverstein Avedro Senior Management Team
  • 6. 755 Avedro devices sold worldwide 78 countries with Avedro devices Avedro’s Approved Countries Commercial Infrastructure for Growth SALES & DISTRIBUTION United States • 10 member direct sales team • 6 member direct service team Outside the United States • 66 distributors • 200 sales and service reps INSTALLED BASE
  • 7. PiXL … The Future of Refractive CXL
  • 8. PiXL: Photorefractive Intrastromal Cross-linking UVA patterning is applied with the Mosaic System to the center of the riboflavin-soaked cornea for myopia correction PiXL Myopia Treatment Goal: induce focal stiffening in the cross-linked regions, resulting in “bulging” of the cornea in untreated regions in response to the normal intraocular pressure
  • 9. Prospective Epi-Off Clinical Trial Ruhr University, Bochum, Germany A prospective evaluation of the safety and efficacy of the KXL II system for photorefractive intrastromal cross- linking (PiXL) for the treatment of Myopia 40 Eyes with Myopia Follow-up at 1, 3, 6 and 12 Months Evaluations to include: • UCVA • BSCVA • Autorefraction • Manifest refraction • Slit lamp examination • Intraocular Pressure Measurement • Anterior Segment OCT • Pentacam measurements • Aberrometry • Specular Microscopy Professor H. Burkhard Dick Matthias Elling, MD Ruhr University Bochum, Germany
  • 10. Initial 12 month results demonstrate the stability of the procedure from 3 months, confirming the feasibility of PiXL as a refractive treatment Prospective Clinical Trial: Stability Ruhr University, Bochum, Germany Potential to reduce recovery time and speed stabilization by avoiding epithelial removal. 12 Month Stability (n=9)
  • 11. Transepithelial PiXL Pilot Study Dr. Julian Theng and Dr Lim Wee Kiak Eagle Eye Ctr. Singapore Demographic: 14 myopic eyes (1.62 ± 0.6D) Post-op checks: Objective • Safety – BCVA, ECC, Slit lamp evaluation • Efficacy – UCVA, manifest Rx, Contrast Sensitivity, Corneal topography Subjective • Questionnaire Sphere Cylinder Treatment Zone UV Energy Treatment Time -0.50 to -0.75D < -0.50D 4.5mm 10J 11 min 11 sec -1.00 to -1.50D < -0.50D 4.5mm 15J 16 min 39 sec Dr. Julian Theng Medical Director Eagle Eye Ctr. Singapore
  • 12. Transepithelial PiXL Pilot Study Dr. Julian Theng and Dr Lim Wee Kiak Eagle Eye Ctr. Singapore Mean gain in VA: 0.35 log unit (3.5 snellen lines) Average MRSE reduction: 0.80 ± 0.45D * MRSE – Manifest Refraction Spherical Equivalent
  • 13. Upcoming Transepithelial PiXL Studies 20+ Healthy Myopic Eyes Per Site Intended correction: -0.75 to -2.0D sphere, 0 to 0.75 D cyl No prior corneal surgery Investigator-Initiated Pilot Clinical Trials of Transepithelial PiXL with Supplemental Oxygen for Treatment of Low Myopia Principal Investigators: Prof. H. Burkhard Dick Ruhr University, Bochum, Germany Prof. François Malecaze Hôpital Purpan Toulouse, France Prof. Anders Behndig Umea University Hospital Umeå, Sweden

Editor's Notes

  1. 258,065 - 103,226 - 180,645 - 103,226 - 103,226 51,613 LASIK Vision Correction History and Statistics LASIK Statistics Number of LASIK vision correction procedures performed worldwide through 2006: 24.6 million +3.7+3.5+2.8=34.6 Number of LASIK vision correction procedures in the US through 2004: 10.9 million + 4.5 = 15.4 @ 2009 Number of US surgeons in 2006 who performed refractive surgery: 3,762 Number of excimer lasers world wide October 2006: 5,335 Number of excimer lasers US October 2006: 1,400 Number of procedures referred by an optometrist 2006: approximately 207,000 (Source: 2006 Market Scope Comprehensive Report in the Global Refractive Market) MarketScope, our industry barometer, noted in its August 12, 2009 newsletter, Ophthalmic Market Perspectives, “Persistently low consumer confidence and tight credit continued to severely reduce demand for refractive surgery in Q2-2009, especially when compared to a relatively robust Q2-2008. Six quarters of double-digit volume declines has begun to take a severe toll on U.S. laser vision surgery providers and led to record number of laser center closures. Although there are some signs of improvement in the economy, continuing high rates of unemployment and economic stress are expected to dampen consumer confidence and restrict demand for vision correction surgery for the balance of 2009. U.S. laser refractive procedures declined 30.8% to 192,000 in Q2-2009 when compared with 277,000 procedures in Q2-2008.”  1,200,000 - 2006 1,400,000 - 2007 4X 277,000 = 1,100,000 - 2008 4 X 192,000 = 768,000 - 2009 PETTER PETTERSEN, MD The financial crisis is just as serious in Northern Europe as it is in North America and elsewhere, but currently, our region has not seen a resulting decrease in LASIK volume. LASIK procedure volume increased steadily in Norway until 2006, and then the curve flattened. Volume has been stable for the past 3 years—at approximately 15,000 procedures a year in our population of 4.5 million. This is roughly equivalent to the volume of LASIK in the other Nordic countries. 15,000/4,500,000 = .00333333 x 700,000,000 Europe = 2,340,000 treatments .00333333 X .05 = .00016666 X 4,700,000,000 Asia & Latin Am. = 783,000 treatments I practice in a chain of clinics called Memira, a major Northern European LASIK chain with 33 clinics across the Nordic countries. http://www.crstodayeurope.com/Issues/0309/0309_04.php