SPOTLIGHT ON THE PREMIUM CHANNEL – AcuFocus

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Nicholas Tarantino, OD Chief Clinical & Regulatory Officer OIS May 5, 2015

Transcript of SPOTLIGHT ON THE PREMIUM CHANNEL – AcuFocus

Page 1: SPOTLIGHT ON THE PREMIUM CHANNEL – AcuFocus

Nicholas Tarantino, ODChief Clinical & Regulatory Officer

OISMay 5, 2015

Page 2: SPOTLIGHT ON THE PREMIUM CHANNEL – AcuFocus

KAMRA® Inlay (Ages 45-60)FDA approved; commercially available in 50 countries

6 μm Thick

8,400 micro-perforations (5-11 μm) allow nutrient flow

Inlay matches corneal curvature

1.6mm Central Aperture

Improves near vision with minimal impact to distance vision− Achieves long-lasting results even as presbyopia progresses

Implanted into corneal pocket created with femtosecond laser− Implanted monocularly into non-dominant eye

Removable via low-risk procedure with recovery of pre-inlay vision

Made from Polyvinylidene Fluoride (PVDF)

3.8 mm Diameter

KAMRA Inlay: Effective, Reliable Presbyopia Solution

Thickness less than the size of a red blood cell

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KAMRA® Inlay Commercial Success in the US

• The KAMRA inlay is the first product to be designed and approved for treatment of presbyopia in over a decade

• Controlled product launch nationally• Exceeding every internal metric within the first 12 months

Details Key Dates & MetricsKAMRA® inlay approval Approved April 17, 2015

Commercial KAMRA inlay launch June 2015

Total number of inlays implanted 2000+

Percent of surgeons who have reordered 82.5%

Average reorder time 1 month

Monthly implant growth since launch 200%

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Small Aperture Comes to the United StatesKAMRA® Inlay Approved April 17, 2015

Mean Visual Acuity in KAMRA® Inlay Eye

Number of Patients Uncorrected DVA Uncorrected NVA

Pre-op 504 20/25 J6

1 Month 344 20/28 J2

3 Months 196 20/27 J2

6 Months 52 20/25 J2

Mean Bilateral Visual Acuity

Number of Patients Uncorrected DVA Uncorrected NVA

Pre-op 526 20/22 J6

1 Month 336 20/20 J2

3 Months 200 20/20 J2

6 Months 52 20/20 J2

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The KAMRA® Inlay Pull Through EffectAccelerating Growth in Refractive Practices

Average % Growth Since Adding the KAMRA Inlay

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IC-8™ IOL SpecificationsApproved in Europe, Australia and New Zealand

• Material - Benz R&D HF1.2 Hydrophobic Acrylic– Optical purity >99.98%– Water content <4%– Refractive index: 1.483– ABBE No. 49

• Optical Design– Single piece 360o square edge– 6.00 mm optic diameter– 12.50 mm overall diameter– 5o Haptic angulation– Spherical posterior surface– Aspheric anterior surface– A-constant = 120.4 – ACD 6.60

• Single-Use Injector System – (current)– 3.5 mm incision for capsular bag insertion, non-folding – 2.8 mm incision under development

IOL MaterialSingle-piece hydrophobic acrylic

Mask PVDF & nano-particles of carbon1.36mm aperture3.23mm total diameter3200 microperforations5 microns thick

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Binocular Defocus Curves:Distance-corrected and Target-corrected IC-8™ IOL with Monofocal IOL

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Binocular Defocus Curve (IC-8 with monofocal IOL, Distance-Corrected vs

Target-Corrected)

Acual Distance-correced OU (n=95)

Actual Target-corrected IC-8/Distance-corrected mono (n=6)

Defocus (D)

Visu

al A

cuity

(log

MAR

)• Target-correcting the IC-8 IOL eye to -0.75 D while keeping the monofocal

IOL at plano adds near vision without sacrificing distance vision

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IC-8™ IOL Visual Acuity Results Uncorrected and Target-Corrected Mean Visual Acuities

Number of Patients Uncorrected DVA Uncorrected IVA Uncorrected NVA

1 Month 102 20/20 20/20 20/32

3 Months 93 20/20 20/20 20/32

6 Months 63 20/16 20/20 20/25

Number of Patients

Target-Corrected DVA*

Target-Corrected IVA*

Target-Corrected NVA*

1 Month 102 20/20 20/20 20/25

3 Months 93 20/20 20/20 20/25

6 Months 63 20/16 20/20 20/25

• Visual Acuities at 1, 3, and 6 months

* Target correction is -0.75 for IC-8 eye and plano for monofocal eye

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Competitive Comparison of IOL Image QualityIC-8™ IOL has the broadest range of high quality continuous functional vision

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AT LISA Tri IC-8, SA

TECNIS Mono ReSTOR 3.00

TECNIS 2.75 Symfony

Through Focus Image Quality Bench Test Data, 50 lp/mm, ISO Model Eye, White Light (Halogen 440 - 755 nm), in Aqueous

MT

F Im

age

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lity,

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lp/m

m

Relative Defocus (Diopter)-1.0 -0.5 0.0 0.5 1.0 1.5 2.0 2.5 3.0

Unusable Vision

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0.0D +0.5D +1.0D +1.5D +2.0D +3.0D

AcuFocus IC-8™ IOL (Target-corrected to -0.75D)

Symfony IOL

AcriLisa Trifocal IOL

(Far Focus) (Near Focus)

Defocus Image Data – White Light, ISO Model Eye, In Aqueous

Monocular Through Focus ImagingIC-8™ IOL vs. Symfony IOL & AcriLisa Trifocal IOL

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Tolerance to Uncorrected Astigmatism(IC-8™ Eyes vs. Monofocal Eyes)

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Cylinder Defocus Curves IC-8 IOL vs Monofocal IOL

IC-8Monofocal

Cylinder Defocus

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ge in

Visu

al A

cuity

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MAR

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N=10

One line of loss

• Change in distance visual acuity compared to the visual acuity corrected at manifest refraction at each cylinder defocus step was plotted against cylinder defocus steps(0.50 D steps)

• The IC-8 IOL is capable of addressing 82% of cataract patients (< 1.50 D) presenting with astigmatism without the need for additional incisional procedures or axis alignment

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Therapeutic Uses for the IC-8™ IOLPositive Results for Therapeutic Applications Extends IOL Value

Images courtesy of Burkhard Dick, MD

• Therapeutic uses for small aperture IOL– Highly aberrated corneas

• Post RK• Post LASIK

– Iris abnormalities

• CASE EXAMPLE: Iris Trauma– Pre-op

• Visual acuity = 0.2 (+18 D)• Complains of significant glare/light

sensations/photophobia– 3 days post-IC-8™ IOL insertion

• UCDVA: 1.0p, UCNVA: 0.8• Patient: very happy, no glare, no light

blindness

Case example and images courtesy of Prof Burkhard Dick12

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What Does All This Mean“We are facing a real revolution with the IC-8 IOL. This technology has overcome the older one . . . multifocals and bifocals will disappear soon from our surgical field.”

Matteo Piovella, M.D.

“The IC-8 is the lens for everybody.” Prof. Burkhard Dick, M.D.

“IC-8 in my opinion is the best IOL for patients who were treated for corneal refractive surgery “

Simonetta Morselli, M.D.13

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Small Aperture SolutionPresbyopia and cataract solutions for unmet physician and patient needs

KAMRA® Inlay IC-8™ IOL• No. 1 corneal inlay with +5-year clinical

track record and 20K implanted worldwide

• Only US approved corneal-based premium procedure labeled both for extended depth of focus (EDOF) and presbyopia correction

• Available in 50 countries

• Long-lasting, complete, natural range of vision; minimally invasive; reversible

• Treats wide patient range: early emmetropic presbyopes

• New EDOF IOL with favorable clinical experience

• CE Marked with EDOF labeling, approved in Australia

• Monocular implantation with results similar to KAMRA inlay

• Overcomes other PC-IOL limitations (incomplete range of vision, unreliability, glare/halo, neuroadaptation)

• Ideal for cataract-age presbyopes

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Extended Depth-of-Focus with Small Aperture Optics

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THANK YOU

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