Anterior Segment Company Showcase - Avedro at OIS@AAO 2016.
Presenter:
Rajesh K. Rajpal, MD, Chief Medical Officer
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3. First and Only FDA Approved Cross-Linking
Now a Reality
MA-00569A
4. 4
Reza Zadno – CEO
Rajesh K. Rajpal, MD - CMO
Steven Blinn - COO
Marc Friedman, PhD – CSO
Senior Management Board of Directors
Robert J. Palmisano
Joe Mandato, PhD
Gil Kliman, MD
Jonathan Silverstein
Avedro Senior Management Team
Lead Investors: InterWest and OrbiMed
MA-00569A
5. >140,000 crosslinking procedures
performed worldwide
60 Countries covered
Avedro’s Approved Countries
Global Presence
United States
• Only FDA approval for progressive
Keratoconus and post-refractive corneal
ectasia
• Direct Sales and Service Reps
• Only GMP riboflavin
Outside the United States
• Lasik Xtra, PRK Xtra, SMILE Xtra
• Accelerated Crosslinking
• PiXL for Myopia
• 42 International Distributors
MA-00569A
7. PiXL: Photorefractive Instrastromal Cross-linking
• UVA patterning is applied
to the center (myopia), the
midperiphery (hyperopia),
or a bowtie shaped region
(astigmatism) of the
riboflavin-soaked cornea
• 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
Myopia Treatment
Hyperopia Treatment
MA-00569A
8. Cosimo Mazzotta MD, PhD
Department of Medical Surgical and
Neurosciences, Ophthalmology Unit
University of Siena, Italy
MA-00569A
9. 7.6 Million
18-44 yr eyes <-2.75D
PiXL Target Market
45 Million
US Contact Lens Patients
700k
Annual US
LASIK Procedures
Why PiXL …
A New Category of Low Myopia Treatment
MA-00569A
10. 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
MA-00569A
11. Average MRSE reduction for high dose: 1.375 D
Average MRSE reduction low dose: 1.00 D
Diopters
0.00
0.25
0.50
0.75
1.00
1.25
1.50
1.75
15 J 10 J
1 Month 3 Months 6 Months
Prospective Epi-Off Clinical Trial
Ruhr University, Bochum, Germany
MA-00569A
12. Transepithelial PiXL Pilot Study
Dr. Julian Theng and Dr Lim Wee Kiak Eagle Eye Ctr. Singapore
Demographic:
14 eyes with low myopia (<2.00 D)
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
MA-00569A
13. Transepithelial PiXL Pilot Study
Dr. Julian Theng and Dr Lim Wee Kiak Eagle Eye Ctr. Singapore
Average MRSE reduction: 0.75 ± 0.42D
* MRSE – Manifest Refraction Spherical Equivalent
MA-00569A
14. Transepithelial Studies launched:
PiXL with Oxygen for Treatment of Low Myopia
20+ Healthy Myopic Eyes Per Site
Intended correction:
-0.75 to -2.0D sphere, 0 to 0.75 D cyl
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
MA-00569A
16. KXL:
Only FDA
Approved
Protocol for
Progressive KCN
Multi-$Billion
Markets
PiXL:
CE Marked
Non-Invasive
Refractive
Experienced
Management
Team
Foundation for Success
High Margin Drugs:
Only GMP
Approved
RiboflavinGlobally
Commercial
Enterprise
MA-00569A
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, MDThe 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