Public Device & Biopharma Ophthalmology Company Showcase - Adverum Biotechnologies
OPHTHALMOLOGY INNOVATION SHOWCASE - Avedro
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Transcript of OPHTHALMOLOGY INNOVATION SHOWCASE - Avedro
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The Present and Future of CXL
Rajesh K. Rajpal, MDChief Medical Officer
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Financial Disclosures
• Avedro, Inc: Employee, Investigator, Shareholder
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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
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FDA Approved Indication
INDICATION AND USAGEPhotrexa Viscous and Photrexa are photoenhancers indicated for use with the KXL System in corneal collagen cross-linking for the treatment of progressive keratoconus.
CONTRAINDICATIONSNone
WARNINGS AND PRECAUTIONSUlcerative keratitis can occur. Monitor for resolution of epithelial defects.
ADVERSE REACTIONSThe 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.
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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
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755 Avedro devices sold worldwide
78 countries with Avedro devices
e
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
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PiXL …The Future of Refractive CXL
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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
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Prospective Epi-Off Clinical TrialRuhr 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 MyopiaFollow-up at 1, 3, 6 and 12 MonthsEvaluations to include:
• UCVA • BSCVA• Autorefraction• Manifest refraction • Slit lamp examination• Intraocular Pressure
Measurement• Anterior Segment OCT• Pentacam measurements• Aberrometry• Specular Microscopy
Professor H. Burkhard DickMatthias Elling, MD
Ruhr UniversityBochum, Germany
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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: StabilityRuhr University, Bochum, Germany
Potential to reduce recovery time and speed stabilization by avoiding epithelial removal.
12 Month Stability (n=9)
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Transepithelial PiXL Pilot StudyDr. 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 ThengMedical DirectorEagle Eye Ctr.Singapore
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Transepithelial PiXL Pilot StudyDr. 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
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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 DickRuhr University,Bochum, Germany
Prof. François MalecazeHôpital PurpanToulouse, France
Prof. Anders BehndigUmea University HospitalUmeå, Sweden
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Avedro Booth 1601