Refractive Cataract Surgery with the Femtosecond Laser

Refractive Surgery Media BriefingOctober 18, 2010

AAO • Chicago

Richard L. Lindstrom, MDFounder and Attending Surgeon:

Minnesota Eye ConsultantsAdjunct Professor Emeritus: University of

MinnesotaAssociate Director: Minnesota Lions Eye

Bank

Disclosures

Acufocus, Inc. C,I,R, Abbott Medical Optics, Inc. C,I, Adoptics, C, Advanced Refractive Technologies CAlcon Laboratories, Inc. C, AqueSys C,I Bausch & Lomb, Inc. C,I,R, Bio Syntrx C,I

Bradley Scott, Inc, C, I, Calhoun Vision Inc, C,I Clarity Ophthalmics C,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, Fziomed I, 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, OcularTherapeutix C,I, Lensar C,I

LenSx C,I, , Lifeguard Health, C,I , Lumineyes, Inc. C , Minnesota Eye Consultants, P.A. C,I, Nisco, I, NuLens C,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, Refractec C,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 C Viradax I, Vision Solutions Technologies C,I,

TriPrima, I, Wavefront Systems, I

*C=Consultant *I= Investor * MD= Medical Director *R= RoyaltyTHIS PRESENTATION MAY CONTAIN DISCUSSION OF OFF LABEL USE OF FDA APPROVED DRUGS AND/OR

DEVICES

Market for Refractive Cataract Surgery

Data: Market Scope 2009 Report

Global Cataract Surgery Forecast

547 762 940 1,171 1,443 1,777 2,183 2,629

Private Pay Refractive Cataract Surgery

Draws from largest surgical market• 18M annual WW procedures• Grows to 22M WW by 2015

2005 2010 2015 2020

Patient Pay CMS Rulings

2nd Generation Premium IOL

Image-Guided Laser Surgery

New Standard of

Care

Limitations of Manual Cataract SurgeryVisual 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)

04/22/2023

Common Incidence Vision Threatening IncidencePosterior Capsular Opacification 10-30% Retinal Detachment 0.6-1.7 %

Cystoid Macular Edema (transient) 2-10% Cystoid Macular Edema (persistent) 1-2%Vitreous Loss 1-5% IOL Malposition 0.3%

Corneal Endothelial Cell Loss 4-10% Need for Corneal Transplant 0.3%Endopthalmitis 0.1%

1Pereira et al. JCRS 2006 Oct;32(10):1661-62Park et al. Ophthalmic Surg Lasers Imaging. 2010 Mar-Apr;41(2):236-41

Visual OutcomesCorneal Refractive vs Cataract Surgery

Procedure Goal UCVA Accuracy to Target

Early PRK/LASIK Functional Vision 20/40 or better + 1.00D, 1.00DC

Contemporary LASIK

Spectacle Independence 20/20 or better + 0.25D, 0.25DC

Cataract Surgery Functional Vision 20/40 or better + 1.00D, 1.00DC

Premium Channel IOLs

Spectacle Independence

20/30 or better at distance and near + 0.50D, <0.75DC

04/22/2023

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

04/22/2023

Key Step Current Surgery Refractive Impact Safety Impact

Corneal Incision Underutilized Not Optimized

Astigmatism Infection

Capsulorhexis Variable Sized,Not Centered

Variable IOL Position & Effective Lens Power

Capsular Tears, Posterior Capsule Opacification

Lens Fragmentation Excessive Ultrasound Power Delayed visual recovery Loss of endothelial cells, Capsule Rupture

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

04/22/2023 8

LenSx LaserAlcon LenSx, Inc. • Aliso Viejo, CA

04/22/2023 9

• 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

LensAR Femtosecond LaserLensAR, Inc.Winter Park, FL

04/22/2023 10

• 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

OptiMedica Femtosecond LaserOptiMedica Corp.Santa Clara, CA

04/22/2023 11

• No FDA 510(k) clearances to date

• Clinical studies underway in Santo Domingo, Dominican Republic

• Commercialization projected 2011

• Projected CE mark undisclosed

Technolas Femtosecond WorkstationTechnolas Perfect VisionMunich, Germany

04/22/2023 12

• 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

Image Guided Laser Refractive Cataract Surgery(LenSx Laser)

04/22/2023 13

• 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.

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

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

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)

Refractive Capsulotomy Study

04/22/2023

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

0 <=0.25 <=0.5 <=0.75 <=1.0 <=1.25 <=1.50

10

20

30

40

50

60

70

80

90

100

Laser (n=60) Manual (n=60)Diameter Error (mm)

Perc

ent o

f Sam

ple

(%)

18

Highly Reproducible Refractive Capsulotomy

Only 10% of manual rhexis achieved diameter accuracy of

+/- 0.25mm

0 <=0.25 <=0.5 <=0.75 <=1.0 <=1.25 <=1.50

10

20

30

40

50

60

70

80

90

100

Capsulotomy Diameter Accuracy(Absolute difference between Attempted

and Acheived)Laser (n=60) Manual (n=60)

Diameter Error (mm)

Perc

ent o

f Sam

ple

(%)

04/22/2023

*Using Warren Hill ELPo Calculator http://doctor-hill.com/iol-main/elp.htm

19

Effective Lens Position with Premium LensStatistically Significant Improvement in Precision of IOL Position

F Test p=< 0.05

Additional Safety Benefits Laser Refractive Cataract Surgery

PostOp OCT image of LenSx 2 plane incision

PostOp OCT image of LenSx 3 plane incision

20/15

or B

etter

20/20

or B

etter

20/25

or B

etter

20/30

or B

etter

2.8%

33.3%

75.0%

100.0%BCVA (N=39)

100% of Eyes 20/30 or better at Day 1

No Corneal Edema in 60% of Eyes

EARLY RECOVERY, CLEAR CORNEAS*

Cornea...0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

LenSx - Day 1 SLit Lamp (n=68)

4 (Severe >50%)

3 (Moderate 26%-50%)

2 (Mild 5%-25%))

1 (Trace 0%-5%)

0 (No Evidence 0%)

*Data courtesy SG Slade, MD

Laser Refractive Cataract Surgery

04/22/2023 23

Patient Acceptance of Technology U.S. Experience

04/22/2023 24

“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.

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)

The FutureImproved safety profile of Laser Refractive Cataract Surgery will drive growth in the private pay cataract surgery marketThe 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.

04/22/2023

Thank You