ophthalmology innovation showcase - avedro
TRANSCRIPT
The Present and Future of CXL
Rajesh K. Rajpal, MDChief 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 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.
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
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
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 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
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)
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
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
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
Avedro Booth 1601