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Small Aperture Solution for Presbyopia KAMRA Inlay The TM

The KAMRA Inlay - AcuFocus, Inc. · KAMRA The Inlay Rev erse to white and 25% Pa ... contact AcuFocus at [email protected] and a representative will contact you or visit us at AcuFocus.com

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Page 1: The KAMRA Inlay - AcuFocus, Inc. · KAMRA The Inlay Rev erse to white and 25% Pa ... contact AcuFocus at info@acufocus.com and a representative will contact you or visit us at AcuFocus.com

Small Aperture Solution for Presbyopia

KAMRA InlayThe

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Reversed Logos: 25% Pantone process blue • 25% blackfonts used: KAMRA: Berkeley Oldstyle Medium • TAGLINE: Akzidenz Grotesk Light horizontally scaled at 130%

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Page 2: The KAMRA Inlay - AcuFocus, Inc. · KAMRA The Inlay Rev erse to white and 25% Pa ... contact AcuFocus at info@acufocus.com and a representative will contact you or visit us at AcuFocus.com

By applying the depth of focus principle commonly used in photography, the KAMRATM inlay controls light transmission allowing only central rays to reach the retina through the fixed 1.6 mm aperture.5,6

Understanding Small Aperture Optics

Before the KAMRA Inlay: The presbyopic eye is unable to focus light.

Lens cannot focus

After the KAMRA Inlay: Clinical results have confirmed that the central 1.6 mm aperture is the optimal size for improving near vision and maintaining distance vision.2

KAMRA inlay

Becoming a KAMRA Inlay Surgeon To learn more about how the KAMRA inlay is helping surgeons around the world deliver a long-term solution to presbyopia, contact AcuFocus at [email protected] and a representative will contact you or visit us at AcuFocus.com.

Page 3: The KAMRA Inlay - AcuFocus, Inc. · KAMRA The Inlay Rev erse to white and 25% Pa ... contact AcuFocus at info@acufocus.com and a representative will contact you or visit us at AcuFocus.com

6µ thin

1.6 mm

3.8m

m

8,400 laser etched perforations to support corneal health

The Presbyopia Solution You’ve Been Waiting For

•FullRangeofVision: Delivers a complete uninterrupted range of vision2

•ExcellentOutcomes: Achieves an average of J2 uncorrected binocular visual acuity at near and 20/16 uncorrected binocular visual acuity at far in clinical study patients3

•HighSafetyProfile: Provides an option to remove the inlay, which keeps patient’s future options open4

The KAMRA Inlay Delivers:

By 2020, there will be an estimated 2.1 billion presbyopes worldwide.1 While multiple options exist to treat this patient segment, some are temporary and most require significant compromise. For surgeons seeking a long-lasting solution for these patients, there is the KAMRA™ inlay.

Page 4: The KAMRA Inlay - AcuFocus, Inc. · KAMRA The Inlay Rev erse to white and 25% Pa ... contact AcuFocus at info@acufocus.com and a representative will contact you or visit us at AcuFocus.com

ExtendedDepthofFocusThe design of the KAMRA inlay delivers an extended depth of focus while: • Maintaining contrast sensitivity in all lighting conditions • Allowing the patient to see from near to far without blur zones • Providing the ability to achieve up to 2.25 diopters (D) of add (achieved when patient has a refraction between -0.50 D and -0.75 D)

The KAMRATM Inlay Difference

The images above represent a patient’s range of vision before and after the KAMRA inlay.

Before the KAMRA Inlay After the KAMRA Inlay

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KAMRA Inlay: Binocular Mesopic Contrast Sensitivity Without Glare2

Spatial Frequency (cpd)

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CS

Curves slightly offset for ease of comparison

(Mean, SD)

Page 5: The KAMRA Inlay - AcuFocus, Inc. · KAMRA The Inlay Rev erse to white and 25% Pa ... contact AcuFocus at info@acufocus.com and a representative will contact you or visit us at AcuFocus.com

Most monovision corrections are performed in excess of +0.75 D, often greater than +1.50 D, which decreases stereopsis to a considerably greater extent.7

Maintain Stereopsis With the KAMRATM inlay, there is no change to the refraction of either eye, allowing both eyes to be refracted to their optimal acuity. This is why a KAMRA patient can enjoy excellent vision from near to far. Unlike the KAMRA inlay, monovision does change the refraction of at least one eye, which typically results in the loss of binocularity and stereopsis.

Long-Term Performance Outcomes from a long-term study demonstrate KAMRA patients achieve mean uncorrected visual acuity of 20/25 in their inlay implanted eye across all distances. This change represents an average gain of 3.2 lines of near acuity. After five years of follow-up, vision remained stable, with no need to exchange for a higher power.8 The US pivotal clinical study data reported an average gain of about 3 lines of near visual acuity.3

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Uncorrected Near Visual Acuity (Inlay Eye Only)

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Page 6: The KAMRA Inlay - AcuFocus, Inc. · KAMRA The Inlay Rev erse to white and 25% Pa ... contact AcuFocus at info@acufocus.com and a representative will contact you or visit us at AcuFocus.com

References1. Market Scope, The Comprehensive Report on The Global Presbyopia Surgery Market, 20142. Data on file at AcuFocus, Inc.3. PMA data on file at AcuFocus, Inc.4. Yilmaz Ö, Alagöz N, Pekel G, Azman E, Aksoy E, Çakir H, Bozkurt E, Demirok A. Intracorneal Inlay to Correct Presbyopia: Long-Term Results. J Cataract Refractive Surg. 2011;37(7):1275-1281.5. Yilmaz OF, Bayraktar S, Agea A, Yilmaz B, McDonald MB, van de Pol C. Intracorneal Inlay for the Surgical Correction of Presbyopia. J Cataract Refract Surg. 2008;34(11):1921-1927. 6. Seyeddain O, Riha W, Hohensinn M, Nix G, Dexl A, Grabner G. Refractive Surgical Correction of Presbyopia With the AcuFocus Small Aperture Corneal Inlay: Two-year Follow-up. J Refract Surg. 2010;26(XX)1-9. 7. Fernandez et al. Impact on Stero-Acuity of Two Presbyopia Correction Approaches: Monovision and Small Aperture Inlay. Biomedical Optical Express. 2013;4(6). 8. Dexl AK et al. Long-term outcomes after monocular corneal inlay implantation for the surgical compensation of presbyopia. J Cataract Refract Surg. 2015 Mar;41(3):566-75.

Indications for Use:The KAMRATM inlay is indicated for intrastromal corneal implantation to improve near vision by extending the depth of focus in the non-dominant eye of phakic, presbyopic patients between the ages of 45 and 60 years old who have cycloplegic refractive spherical equivalent of +0.50 D to -0.75 D with less than or equal to 0.75 D of refractive cylinder, who do not require glasses or contact lenses for clear distance vision, and who require near correction of +1.00 D to +2.50 D of reading add.

Summary of Important Information:• TheKAMRATM inlay procedure may not eliminate the need for reading glasses. • TheKAMRAinlayproceduremaycauseblurredvision,difficultieswithcontrastsensitivity,problemswithnightvision,doublevision,ghostimages,glare,halos,andcolor

disturbances. Patients may also feel pain, dryness, burning, discomfort and look red. • Otherrisksthepatientmayexperienceincludeinfection,swelling,thinning,orinflammationofthecornea,andchangesinthepatient’svision.• TheKAMRAinlayCANberemoved.Duringtheclinicalstudy,afterremovaloftheinlay,visiongenerallyreturnedtothelevelthepatienthadpriortotheimplantationwith

theKAMRAinlay.However,thisdoesnotguaranteethatthepatient’svisionwillreturntoexactlywhatitwasbeforesurgeryorthattheeyewillnothavepermanentdamage.• Non-surgicalalternativestotheKAMRAinlayprocedureincludetheuseofreadingglassesorcontactlenses.• BeforeconsideringtheKAMRAinlayprocedurethepatientshould:1)Haveacompleteeyeexaminationand,2)Talkwiththeireyesurgeonaboutthealternativesto

treatment, potential benefits, complications, risks, and time required for healing.

The KAMRA inlay may be covered by one or more of the following: U.S. Patents 7,404,637; 7,628,810; 7,976,577; D656,526; 8,287,592; 8,460,374; other U.S. and foreign patents pending AcuFocus, Inc., KAMRA, the KAMRA logo, Small Aperture Solution for Presbyopia, and Across the Page, Across the Room, Across the Years, are trademarks of AcuFocus, Inc. © 2015 AcuFocus, Inc. All rights reserved.

AcuFocus, Inc. • 32 Discovery #200 • Irvine, CA 92618 • 1-949-585-9511 • www.AcuFocus.com

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