Laser Refractive Cataract Surgery with the LenSx Laser

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Vernon Hutchinson
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1 Laser Refractive Cataract Surgery with the LenSx Laser a Novartis company

2 LenSx Laser 2

3 3 An Evolving Definition of Cataract Average Age of US Cataract Patient is Projected to Decline Today: earlier diagnosis & treatment before substantial vision loss In 2011, almost 800,000 surgeries will be performed on patients years old New surgical approaches available to improve UCVA for many patients Established LASIK market validates that patients will pay for surgically improved vision

surgeries will be performed on patients 55-64 years old New surgical approaches available to

4 4 The Changing Face of Cataract Surgery The Baby Boomer Generation - Large, rapidly growing demographic - Educated, financially secure - Increased life expectancy - Longer working careers - Demand high quality vision (reading, distance, night vision) - New requirement for near vision (computers) - Unwilling to compromise active lifestyle - Embracing demand driven healthcare

careers - Demand high quality vision (reading, distance, night vision) - New requirement for

5 5 Laser Refractive Cataract Surgery Will the femtosecond laser: Incite new interest among patients for an elective refractive cataract surgery procedure? - Yes, 70% of LASIK flaps now made with femtosecond laser! 1 Increase the VALUE of Refractive Cataract Surgery? Value will be driven and dictated by the Baby Boomer generation - Reproducible predictability must be demonstrated - Outcomes similar to LASIK will be required - A more concierge-like experience will be expected 1 Mahdavi S, Three-year perspective on the business impact of IntraLase technology, sm2strategic.com/files/intralasesurvey2005, Accessed 03 July 2011.

Value will be driven and dictated by the Baby Boomer generation - Reproducible predictability must be demonstrated - Outcomes similar to LASIK will be

6 6 The Need for Improvement

7 7 Limitations of Traditional Cataract Surgery

8 8 Improved Refractive Cataract Surgery Address Major Requirements for Improved Refractive Procedure IOL Position Predictability Uniform Shape and Size Capsulotomy Corneal Astigmatism Reproducible Corneal Entry and Arcuate Incisions Early Wow Factor Reduced Phaco Power and Corneal Edema Norrby SJ, J Cataract Refract Surg 2008;34: Hill WJ, J Cataract Refract Surg 2008;34: Devgan U, Current Opinions in Ophthalmology 2011;18:19 22.

$Arcuate Incisions Early Wow Factor Reduced Phaco Power and Corneal Edema Norrby SJ, J Cataract Refract Surg$

9 9 The LenSx Laser A dynamic, platform technology designed to: Deliver the precision of a femtosecond laser to Refractive Cataract Surgery Rapidly advance the evolution of true image-guided intraocular surgery Advance the development of a more digitized, predictable approach to lens replacement surgery

advance the evolution of true image-guided intraocular surgery Advance the

10 10 Image-Guided Refractive Cataract Surgery

11 11 Manual Clear Corneal Incisions Dynamics of wound architecture created with hand-held instruments 1 : - imprecise tunnel length and geometry - frequently require stromal hydration to seal - may result in cascading intraoperative difficulties (fluid control, anterior chamber maintenance) - incisions may be unstable at low IOPs Recent literature suggests an increased incidence of post-op infection 2 1 Behrens A, Stark WJ, Pratzer KA, McDonnell PJ. Dynamics of small-incision clear cornea wounds after phacoemulsification surgery using optical coherence tomography in the early postoperative period, J Refract Surg, 2008;24(1): Taban M, Behrens A, Newcomb RL, Nobe MY, Saedi G, Sweet PM, McDonnell PJ. Acute endophthalmitis following cataract surgery: a systematic review of the literature, Arch Ophthalmol. 2005;123(5):

$Dynamics of small-incision clear cornea wounds after phacoemulsification surgery using optical coherence tomography in the early postoperative period, J Refract Surg, 2008;24(1):46-9.$

12 12 LenSx Laser Corneal Incisions Customized wound architecture and placement Self-sealing incisions

13 13 Effective Lens Position (ELP) The key to highly accurate IOL power calculation is being able to correctly predict ELP for any given patient and IOL 1 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 2 and key to post surgery refraction 3 Size of capsulorhexis effects ELP 4 1 Haigis W, Lege B, Miller N, Schneider B, Comparison of immersion ultrasound biometry and partial coherence interferometry for IOL calculation according to Haigis, Graefes, Arch Clin Exp Ophthalmol, 2000;238: Norrby S, Sources of error in intraocular lens power calculation,j Cataract Refract Surg, 2008;34: Hill WE, Does the Capsulorrhexis Affect Refractive Outcomes? In Chang D, editor: Cataract and Refractive Surgery Today, 2009:78. 4 Cekiç O, Batman C, The relationship between capsulorhexis size and anterior chamber depth relation. Ophthalmic Surg Lasers, 1999;30(3): Erratum in: Ophthalmic Surg Lasers,1999;30(9):714

$factor) A significant source of IOL power error 2 and key to post surgery refraction 3 Size of capsulorhexis effects ELP 4 1 Haigis W, Lege B, Miller N, Schneider B, Comparison of immersion$

14 14 Factors Affecting IOL Predictability 1 If IOL is 0.5 mm posterior to the assumed plane, a 21 D lens will produce only 20 D of correction Hyperopic If IOL is 0.5 mm anterior to the assumed plane, a 21 D lens will produce 22 D of correction Myopic 1 Norrby S, Sources of error in intraocular lens power calculation,j Cataract Refract Surg, 2008;34:

15 15 Does Capsulotomy Size Impact ELP? Consistent capsulorhexis diameter is critical to Effective Lens Position 1,2 A 4 mm capsulorhexis results in longer post-operative ELPo than does a 6 mm capsulorhexis for the type of IOL used 3 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 optic 2 1 Hill WE. Hitting Emmetropia. Chang D. (ed.) In: Mastering Refractive IOLs The Art and Science. Slack, Incorporated, Hill WE. Does the Capsulorhexis Affect Refractive Outcomes? Chang D. (ed.) In: Cataract Surgery Today, Bryn Mawr Communications, Wayne, Pennsylvania p Cekiç O, Batman C, The relationship between capsulorhexis size and anterior chamber depth relation. Ophthalmic Surg Lasers, 1999;30(3): Erratum in: Ophthalmic Surg Lasers,1999;30(9):714

$Hitting Emmetropia. Chang D. (ed.) In: Mastering Refractive IOLs The Art and Science. Slack, Incorporated, 2008. 2 Hill WE. Does the Capsulorhexis Affect Refractive Outcomes? Chang D. (ed.) In: Cataract Surgery Today, Bryn Mawr Communications, Wayne, Pennsylvania 2009.$

16 16 Laser Fragmentation Mechanism of Action Chop Patterns Cylinder Patterns

17 Average Power (%) Effective Phaco Time (min) 17 LenSx Laser Phacofragmentation Cylinder pattern, utlilized for the softer lens, enables removal with I & A only, no phaco power Chop pattern efficiently fragments the lens for removal with reduced phaco power and time 1 Comparison of Average Phaco Power Comparison of Effective Phaco Time Phaco only Laser plus Phaco Phaco only Laser plus Phaco % reduction 43% reduction 1 Nagy ZZ, Takacs A, Filkorn T, Sarayba M, Initial Clinical Evaluation of an Intraocular Femtosecond Laser in Cataract Surgery, Journal of Refractive Surgery, 2009;25:

Effective Phaco Time 30 25 1.4 1.2 1 20 15 10 Phaco only Laser plus Phaco 0.8 0.6 0.4 Phaco only Laser plus Phaco 5 0.

$19 Treatment of Pre-Existing Astigmatism Cataract and refractive surgeons report that between 5 and 30% of their patients require$

18 19 Treatment of Pre-Existing Astigmatism Cataract and refractive surgeons report that between 5 and 30% of their patients require LASIK, LRI or some other secondary enhancement procedure in order to improve their visual outcomes Market Scope Global IOL report.

LASIK, LRI or some other secondary enhancement procedure in order

19 20 Arcuate Incisions Manually executed by tracing corneal marks with handheld diamond knife Inconsistent depth control Unpredictable effect due to imprecise wound architecture and depth No image-guided surgical planning or visualization

control Unpredictable effect due to imprecise wound

20 21 LenSx Laser Arcuate Incisions Image-guided surgical planning with 3D visualization: Real time corneal thickness Computer programmed incisions - % depth - incision length and position - 3D visualization of incision placement Predictable incision width, tunnel length Titratable incisions - adjustable during surgical procedure - adjustable post-op at slit lamp *510(k) Premarket Notification to the FDA, LenSx Laser System, K101626, 2010.

incision placement Predictable incision width, tunnel length Titratable incisions - adjustable during

21 22 LenSx Laser Arcuate Incision Square edge Uniform depth (no ripples) Precise, reproducible Arc shape Arc length Diameter Steinert RF, Application of the Femtosecond Laser in Cataract Surgery for the Creation of Multi-Planar, Self-Sealing Incisions, ASCRS 2010, Boston

22 25 LenSx Laser vs Manual CCC* Analysis: Non-randomized, prospective, single site, single surgeon study With single lens type, ALCON monofocal SN60WF Manual group (n=26) - Attempted 5.0mm capsulotomy Mastel 5.75 mm OZ marker to create 5.0 mm CCC LenSx Laser group (n=22) - Femtosecond laser created 5.0 mm capsulotomy Accuracy to Target, Actual ELPo (LENSTAR Optical Biometer ACD) No significant difference in baseline between cohorts LENSTAR is a registered trademark of Haag-Streit * Robert J Cionni MD. Presented AAO 2011 Refractive Sub-Specialty Day, Comparison of Effective Lens Position and Refractive Outcome: Femtosecond Laser vs Manual Capsulotomy

26 LenSx Laser vs Manual CCC Actual vs Predicted ELP 5.00 LenSx Laser Group (n=22) 5.00 Manual Group (n=26) 4.75 4.75 Actual ELP 1M PostOP Actual ELP 1M PostOP 4.50 95% Confidence Intervals 4.50 4.

23 26 LenSx Laser vs Manual CCC Actual vs Predicted ELP 5.00 LenSx Laser Group (n=22) 5.00 Manual Group (n=26) Actual ELP 1M PostOP Actual ELP 1M PostOP % Confidence Intervals R² = R² = Predicted ELP Predicted ELP Better ELP predictability 71% of the variable s variance result for the LenSx Laser group Vs. only 29% for the manual group.

24 28 Where Are We Today? The LenSx Laser The only femtosecond laser cleared for all indications in cataract surgery US and CE mark: - Anterior Capsulotomy - Laser Phacofragmentation - Cataract Incisions, including Arcuate Incisions The only femtosecond laser commercialized to date for cataract surgery indication

25 30 Patient Expectations The medical milestone of cataract will be increasingly re-defined by lifestyle requirements This younger, active patient population will seek a surgical resolution much earlier than previous generations LenSx Laser technology provides the patient: Perceived benefits of a laser procedure - Computer controlled precision - Procedural predictability A comprehensive, advanced technology approach to lens replacement surgery A truly premium, value-added surgical experience

26 31 Opportunity for Eyecare Providers LenSx Laser technology provides: Known benefits of femtosecond technology - Improved accuracy of all incisions - Predictability at every step True image-guided intraocular surgery - Opportunity to create optimal wound architecture - Precise capsulotomy design for every IOL A strong value proposition - A message that easily resonates with patients and staff

27 PROBLEMS Primarily financial Insurance companies do not provide an increase in fees when the femtosecond laser is used. Laser costs $475,000. There is a "click" fee charge of $400 every time the laser is used. Annual Maintenance fee of $40,000. Therefore the average cost per case is significant. We are allowed to charge a patient for LRI's which can be performed with the laser. We are also allowed to charge a patient for premium lenses such as toric and multifocals. However, that charge would have to be significantly increased if performed with the Femtosecond laser. How much will the market stand?

Providing Optimal Optics For Your Astigmatic Cataract Patients. While the cornea remains relatively stable and prolate throughout life

Providing Optimal Optics For Your Astigmatic Cataract Patients David I. Geffen, OD, FAAO Why keep the crystalline lens? While the cornea remains relatively stable and prolate throughout life Unless we