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Refractive Cataract Surgery with the Femtosecond Laser

Refractive Surgery Media Briefing October 18, 2010 AAO • Chicago. Richard L. Lindstrom, MD Founder and Attending Surgeon: Minnesota Eye Consultants Adjunct Professor Emeritus: University of Minnesota Associate Director: Minnesota Lions Eye Bank.

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Refractive Cataract Surgery with the Femtosecond Laser

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  1. Refractive Surgery Media Briefing October 18, 2010 AAO • Chicago Richard L. Lindstrom, MD Founder and Attending Surgeon: Minnesota Eye Consultants Adjunct Professor Emeritus: University of Minnesota Associate Director: Minnesota Lions Eye Bank Refractive Cataract Surgery with the Femtosecond Laser

  2. Disclosures *C=Consultant *I= Investor * MD= Medical Director *R= Royalty Acufocus, Inc. C,I,R, Abbott Medical Optics, Inc. C,I, Adoptics, C, Advanced Refractive Technologies CAlcon Laboratories, Inc. C, AqueSysC,I Bausch & Lomb, Inc. C,I,R, Bio SyntrxC,I Bradley Scott, Inc, C, I, Calhoun Vision Inc, C,I Clarity OphthalmicsC,I, Clear Sight C,I, CoDa Therapeutics C,IConfluence Acquisition Partners I, Inc. I, EBV Partners C,I, EGG Basket Ventures C,I, Elenza, C, Encore C,I Evision Photography, C,I,Evision Medical Laser , I, Eyemaginations, Inc. C,I, ForSight, C, Foresight Venture Fund #3, C,I, FziomedI, Glaukos Corporation C,I, HEAVEN Fund I, Healthcare Transaction Services I, High Performance Optics C,I, Hoya Surgical Optics C , Improve Your Vision C,I, OcularTherapeutixC,I, LensarC,I LenSxC,I, , Lifeguard Health, C,I , Lumineyes, Inc. C , Minnesota Eye Consultants, P.A. C,I, Nisco, I, NuLensC,I Ocular Surgery News/Slack,c , Ocular Optics , C,I, Omega Eye Health, C,I,Omeros Corp., C OnPoint, I, Pixel Optics, C,I Quest C,I.R, Rainwater Healthcare. I, RefractecC,I, MD, Revision Optics,I, Revital Vision C, I,, SarboxNP, I, Schroder Life Science Venture Fund , Seros Medical, LLC C, Sight Path, C,I,MD,Solbeam, I , Surgijet/Visijet, C,I 3D Vision Systems C,I, TLC Vision C,I, MD, Tearlabs, Inc. C,I, Tracey Technologies C,I, Transcend Medical, Inc,C,I , True Vision, C,I, Versant CViradaxI, Vision Solutions Technologies C,I, TriPrima, I, Wavefront Systems, I THIS PRESENTATION MAY CONTAIN DISCUSSION OF OFF LABEL USE OF FDA APPROVED DRUGS AND/OR DEVICES

  3. Market for Refractive Cataract Surgery Global Cataract Surgery Forecast 2,629 2,183 1,777 1,443 1,171 940 762 547 Data: Market Scope 2009 Report

  4. Private Pay Refractive Cataract Surgery • Draws from largest surgical market • 18M annual WW procedures • Grows to 22M WW by 2015 New Standard of Care Image-Guided Laser Surgery 2nd Generation Premium IOL Patient Pay CMS Rulings 2005 2010 2015 2020

  5. Limitations of Manual Cataract Surgery • Visual Outcomes • Distance Correction Predictability Half that of LASIK • Astigmatism Correction • Effective Power of IOL • Limits Presbyopia Correction • Safety • Complications 10x LASIK • Ultrasound use in phaco associated with post-op complications such as corneal burn, corneal edema and endothelial cell loss(1,2) 1Pereira et al. JCRS 2006 Oct;32(10):1661-6 2Park et al. Ophthalmic Surg Lasers Imaging. 2010 Mar-Apr;41(2):236-41

  6. Visual OutcomesCorneal Refractive vs Cataract Surgery

  7. Goals of Laser Refractive Cataract Surgery • Improve Every Procedure, Technology and Surgeon • Presbyopia, Astigmatism & Monofocal • Refractive Precision and Integration • New laser-based standard, synonymous with patient pay

  8. Laser Refractive Cataract SurgeryPlatforms in Development • LenSx (Aliso Viejo, CA) • LensAR (Winter Park, FL) • OptiMedica (Santa Clara, CA) • Technolas Perfect Vision (Munich, Germany) • Known projects in undisclosed stages of development: - AMO - Schwind - Zeiss

  9. LenSx LaserAlcon LenSx, Inc. • Aliso Viejo, CA • 2008: 1st femtosecond laser used • clinically in EU for Laser Refractive • Cataract Surgery (Nagy, Budapest) • 1st femtosecond laser to receive FDA • clearance for cataract surgery (2009) • Currently three 510(k) clearances: • - Anterior Capsulotomy • - Corneal Incisions • - Laser Phacofragmentation • 1st Laser Refractive Cataract Surgery • procedure performed in US on • Feb 29, 2010 (Slade, Houston) • US commercialization Q4 2010; • CE mark anticipated early 2011

  10. LensARFemtosecond LaserLensAR, Inc.Winter Park, FL • FDA 510(k) clearance for Anterior • Capsulotomy (2010) • Clinical studies ongoing in Mexico • City (Naranjo-Tackman) and • Manila (Uy) • Also pursuing presbyopia correction • via softening of the lens • Commercialization projected 2011 • Projected CE mark undisclosed

  11. OptiMedicaFemtosecond LaserOptiMedica Corp.Santa Clara, CA • No FDA 510(k) clearances to date • Clinical studies underway in Santo • Domingo, Dominican Republic • Commercialization projected 2011 • Projected CE mark undisclosed

  12. TechnolasFemtosecond WorkstationTechnolas Perfect VisionMunich, Germany • Introduced Customlens procedure via • Technolas Femtosecond Workstation • at ESCRS 2010 (Paris) • Clinical studies ongoing in Bogota • (Auffarth, Ruiz) 2010 • No US regulatory pathway disclosed • CE mark and commercialization • projected early 2011

  13. Image Guided Laser Refractive Cataract Surgery(LenSx Laser) • Integrated OCT scans project images of cornea, lens, iris, capsule onto video microscope • Surgeon selects incisions & lens treatment; patterns are projected onto OCT images and confirmed • OCT projects real-time images during lens fragmentation, capsulotomy and corneal incisions.

  14. Capsulotomy Size and Refractive Outcomes • A 4mm capsulorhexis results in longer postoperative ELP than does a 6 mm capsulorhexis for the type of IOL used • Cekic, Batman. Ophthalmic Surgery and Lasers, March 1999 • To ensure that an IOL’s position in the bag matches the anticipated formula used to calculate its power, the capsulorhexis should be round, centered and smaller than the IOL’s optic • This encourages consistent refractive outcome • Hill W. Cat & Refract Surg Today, Oct 2007 • It is critical to have consistent capsulorhexis diameter to have predictable refractive outcome

  15. Factors Affecting Relative Power of IOL • If IOL is 0.5mm posterior to the assumed plane, a 21D lens will produce only 20D of correction – hyperopic • If IOL is 0.5mm anterior to the assumed plane, a 21D lens will produce 22D of correction – myopic

  16. Importance of Effective Lens Position • ELP for the 5 formulas commonly in use are: • SRK/T d = A-constant • Hoffer Q d = pACD • Holladay 1 d = Surgeon Factor • Holladay 2 d = ACD • Haigis d = a0 + (a1 * ACD) + (a2 * AL) • ELP is assumed value, from empirical data (A constant and surgeon factor) • A significant source of IOL power error, (Norby, 2008) key to post surgery refraction (Hill, 2009) • Size of capsulorhexis effects ELP (Cekic, 1999)

  17. Refractive Capsulotomy Study • Nagy Z, Takacs A, Filkorn T, Sarayba M. Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery. J Refract Surg. 2009;25(12):1053-1060 • . • 100% of LenSx procedures achieved an accuracy of ± 0.25 mm • Only 10% of manual procedures achieved an accuracy of ±0.25 mm • No radial tears

  18. Highly Reproducible Refractive Capsulotomy Only 10% of manual rhexis achieved diameter accuracy of +/- 0.25mm

  19. Effective Lens Position with Premium Lens Statistically Significant Improvement in Precision of IOL Position F Test p=< 0.05 *Using Warren Hill ELPo Calculator http://doctor-hill.com/iol-main/elp.htm

  20. Additional Safety Benefits Laser Refractive Cataract Surgery

  21. PostOp OCT image of LenSx 3 plane incision PostOp OCT image of LenSx 2 plane incision

  22. EARLY RECOVERY, CLEAR CORNEAS* 100% of Eyes 20/30 or better at Day 1 No Corneal Edema in 60% of Eyes *Data courtesy SG Slade, MD

  23. Laser Refractive Cataract Surgery

  24. Patient Acceptance of Technology U.S. Experience • Laser Refractive Cataract Surgery easily resonates with patients – similar to all laser LASIK • Patients perceive surgical steps performed with laser are safer and more precise • First US surgery center converted to 100% Laser Refractive Cataract Surgery within 1 month (Slade – Houston, TX) “As impressive as the performance of the LenSx Laser was, the overwhelmingly positive response from the patients was even more exciting. Patients readily appreciate and choose “laser refractive cataract surgery” – Stephen Slade, M.D.

  25. The Future • Improved safety profile of Laser Refractive Cataract Surgery will drive growth in the private pay cataract surgery market • The precision of a laser procedure that replaces most of the manual, imprecise steps of cataract surgery is titratable. • A laser created, perfectly centered capsulotomy and predictable, concentric capsular contracture reduces variability in effective lens position. • The ability to accurately correct pre-existing astigmatism at the time of surgery will enable surgeons to meet baby boomer expectations for better refractive outcomes. • The precision of Laser Refractive Cataract Surgery will drive rapid innovation in IOL design, and the evolution of less invasive cataract removal techniques.

  26. Thank You

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