ophthalmology innovation showcase - avedro

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.

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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

755 Avedro devices sold worldwide

78 countries with Avedro devices

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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