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Anterior Segment Company Showcase - Avedro
This document discusses the advancements and future of cross-linking treatments, particularly focusing on Avedro's FDA-approved procedures for progressive keratoconus and post-refractive corneal ectasia. It highlights the innovation of PIXL, a photorefractive intrastromal cross-linking technique aimed at treating myopia and other refractive errors. Clinical trials demonstrate its efficacy and position within a multi-billion dollar market, emphasizing the strategic goals and efforts of the company and its leadership.
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Anterior Segment Company Showcase - Avedro
- 1. The Present andFuture of CXL Rajesh K. Rajpal, MD Chief Medical Officer Founder and Medical Director See Clearly Vision Group MA-00569A
- 2. Financial Disclosures • Abbott •Alcon • Allergan • Avedro • Bausch & Lomb • Calhoun • Mimetogen • Ocular Therapeutix • Omeros • Polyactiva • RPS • Santen • Shire • Stemnion • Tear Solutions • Valeant MA-00569A
- 3. First and OnlyFDA 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 performedworldwide 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
- 6. PiXL … The Futureof Refractive CXL MA-00569A
- 7. PiXL: Photorefractive InstrastromalCross-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 yreyes <-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 ClinicalTrial 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 reductionfor 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 PilotStudy 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 PilotStudy 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: PiXLwith 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
- 15. Future PiXL Applications PresbyopiaPost-IOL EnhancementAstigmatism MA-00569A
- 16. KXL: Only FDA Approved Protocol for ProgressiveKCN 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
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Editor's Notes
- #5 258,065 - 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
- #6 6 Direct Service reps 7 Direct Sales Reps
- #7 We are truly the only novel refractive procedure
- #15 Do we want to update this?