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THE PRESBYOPIA SOLUTION FEMTO LDV AND KAMRA INLAY LEAD THE WAY IN PRESBYOPIA CORRECTION by AcuFocus™

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Page 1: THE PRESBYOPIA SOLUTION - Domedics AG · by AcuFocus™ THE PRESBYOPIA SOLUTION After a decade of evolutionary development, the KAMRA™ corneal inlay has proven itself as the solution

THE PRESBYOPIA SOLUTION

FEMTO LDV™ AND KAMRA™ INLAY LEAD THE wAY IN PRESBYOPIA cORREcTION

by AcuFocus™

Page 2: THE PRESBYOPIA SOLUTION - Domedics AG · by AcuFocus™ THE PRESBYOPIA SOLUTION After a decade of evolutionary development, the KAMRA™ corneal inlay has proven itself as the solution

THE PRESBYOPIA SOLUTION

After a decade of evolutionary development, the KAMRA™ corneal inlay has proven itself as the solution for presbyopia for patients and physicians. It is designed to create a small aperture effect, allowing the eye to see near and intermediate objects more clearly while maintaining distance vision.

INNOVATIVE & UNIqUE DESIgN

Every element of the design has been carefully considered and clinically tested so that the end result is a device that improves focus at a range of distances while allowing for a natural corneal metabolic process.

Key design features include:

• 3.8 mm ring with a 1.6 mm central aperture • 5μmthin• 8,400 laser-etched micro-perforations arranged in a

pseudo-random pattern• Madeofpolyvinyledenefluoride(PVDF),commonlyusedin

intraocular lens haptics• 2012MedicalDesignExcellenceAwards®Finalist

PROVEN & PREDIcTABLE RESULTS

clinical & commercial ResultsKAMRA™ inlay patients achieve similar results across surgical procedures:

• Mean Uncorrected near visual acuity: J2 • Mean Uncorrected intermediate visual acuity: 20/25• Mean Uncorrected distance visual acuity: 20/20

Binocular UDVARemains constant from pre-op to post-op.1

Long Term StabilityPeerreviewdatashowthatthevisualresultsaresustainedovertime and the device is biocompatible.2

Reading BenefitsKAMRA™ patients show improvements in reading distance, acuity and speed.3

contrast SensitivityKAMRA™patientsexperiencelittleornoreductionincontrastsensitivity and report performing near, intermediate and distance vision tasks with ease postoperatively, without glasses.4 This includes daily functions such as reading the newspaper and driving at night.

StereoacuityIn a series of 60 KAMRA™ inlay patients, no change in mean distancestereoacuityscoreswasnotedbetweenpre-opandsixmonths post-inlay implantation.5

UNMATcHED VERSATILITY

AwiderangeofpatientscanbenefitfromKAMRA™Vision:

• Ametropic presbyopes• Emmetropic presbyopes• Post-laservisioncorrectionpresbyopes• Pseudophakes

The inlay can be inserted on its own, in combination with other refractive procedures, or as an enhancement to prior cataract or refractive procedure. This kind of versatility makes the KAMRA™ inlaythemostflexiblepresbyopiasolutionavailabletoday.

1 DataonfileatAcuFocus.2 Yilmazetal.IntracornealInlaytoCorrectPresbyopia:Long-TermResults;JCRSJuly2011;37:1275-80.3 DexlAK,SeyeddainO,RihaW,HohensinnM,HitzlW,GrabnerG.Readingperformanceafterimplantationofasmall-aperture

cornealinlayforthesurgicalcorrectionofpresbyopia:Two-yearfollow-up.JCataractRefractSurg.2011;37:525-531.4 ThompsonV.Taskperformanceafterimplantationofsmallapertureinlaytoimprovenearvision.PresentedatASCRSAnnual

Meeting.SanDiego,CA,May2011.5 Dr.StevenLinn,HoopesVisionInstitute,ARVO2012.

KAMRA™ and KAMRA™ stylizedlogosaretrademarksofAcuFocus,Inc.intheUnitedStatesandothercountries.NotethattheAcuFocusinlayhasEuropeanCEmarkapproval.TheKAMRA™inlayisnotclearedforuseintheU.S.A. Availability of the implant according to policy of the manufacturer and regulatory status in the individual countries

"I believe the KAMRA inlay is the best solution for presbyopia on the market today for the 45 – 65 age range."

David Allamby, MD, United Kingdom

Enlarged image of the KAMRA™ inlay

Page 3: THE PRESBYOPIA SOLUTION - Domedics AG · by AcuFocus™ THE PRESBYOPIA SOLUTION After a decade of evolutionary development, the KAMRA™ corneal inlay has proven itself as the solution

THE IDEAL PARTNER FOR ALL PRESBYOPIA TREATMENTS

TheFEMTOLDVZModelsofferuniquesoftwaresolutionsfor implantationoftheKAMRA™inlay.Differentpresbyopia-tailoredapplications are available for you to customize the procedure for thepatient’sspecificconditions:

SIM-LASIKSimultaneousZ-LASIK® and presbyopia correction for ametropic presbyopes. The tightly focused low-energy laser pulses in an overlappedpulserastercreatingflapswithno"tissuebridges"andexcellentstromabedquality.

Intrastromal PocketsIn order to support the treatment of presbyopia with the KAMRA™ inlay a customized pocket software has been developedbyZiemer.

This less invasive procedure is ideal for emmetropic presbyopes and post-refractive patients. Inpost-LASIKpatientstheuniqueFEMTOLDVfemtosecond technology can create a pocket precisely and gently below a pre-existingflap.Atrulysafeprocedurethanksto:

• Highprecisioninthecuttingdepth• Significantlyfewergasbubbles

FEMTO LDV Z MODELS

Modular platform solution

• Convenient on-site upgrades• Tailored application packages • Designedforfutureapplications

Outstanding clinical results

• Excellentvision• Veryfastvisualrecovery• FullcapabilityforLASIK,corneal

surgery and therapeutic procedures

Unique femtosecond technology

• Lowestpulseenergy(nJrange)• Highestpulserepetitionrate(MHz)•Microscopelensqualityoptics

True mobility, true efficiency

• Designedtobemovedbetween different surgical rooms/clinics

• Fitswitheveryexcimer• Noneedtomovethepatient

Page 4: THE PRESBYOPIA SOLUTION - Domedics AG · by AcuFocus™ THE PRESBYOPIA SOLUTION After a decade of evolutionary development, the KAMRA™ corneal inlay has proven itself as the solution

Ziemer Ophthalmic Systems AgaZiemerGroupCompanyAllmendstrasse 11CH-2562Port,SwitzerlandPhone+41323327070

www.ziemergroup.comwww.femtoldv.com

AcuFocus, Inc.32Discovery,Suite200Irvine,California92618USA949-585-9511Phone+18882343810

www.acufocus.comwww.KAMRA.com

"KAMRA intracorneal inlay implantation with the FEMTO LDV for post-LASIK patients is effective for treating presbyopia."

Minoru Tomita, MD, PhD, Japan

cLINIcAL EVIDENcE

More than 15,000 KAMRA™ inlays1 have been implantedto effectively treat presbyopia.

Six-monthresultsofastudybyMinoruTomita,MD,PhD (ShinagawaLASIKCenter,Japan)of630patientsthat underwentaKAMRA™post-LASIKprocedureusingthe FEMTOLDV™showed:

• 91 % of patients reported a reduction in their dependence on reading glasses

• 94 % reported satisfaction with their vision without reading glasses

• Visualacuitygainswereequivalenttoreportedresults for emmetropic presbyopes: –WithmeanUNVAimprovementfromJ8toJ2 –WithmeanUDVAreducingonlyonelinefrom20/16to20/20.2

020/125

20/100

20/80

20/63

20/50

20/32

20/40

20/25

20/20

20/16

20/12.5

5 10 15 20 25 30

IE

OE

BE

J2

J9

Snel

len

Acu

ity

Month

Uncorrected Near Visual Acuity

020/63

20/50

20/40

20/32

20/25

20/20

20/16

20/12.5

5 10 15 20 25 30 35

IE

OE

BE

20/20

Snel

len

Acu

ity

Month

Uncorrected Distance Visual Acuity

Contralateral comparison of mean UNVA and UDVA for the inlay implanted eye (IE), fellow eye (OE) and both eyes (BE) for a series of 32 patients shows that while the fellow eye continues to lose near acuity over time, both the inlay eye and binocularly patients maintain excellent near vision (data courtesy of Günther Grabner, MD).

1 DataonfilebyAcuFocus,June2012.2 TomitaM.TreatmentofPost-LAISKPresbyopiawithSmallApertureCornealInlay:6-MonthResults.PresentedatASCRS

AnnualMeeting.Chicago,IL,April2012.

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