SPOTLIGHT ON THE PREMIUM CHANNEL – AcuFocus
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Transcript of SPOTLIGHT ON THE PREMIUM CHANNEL – AcuFocus
Nicholas Tarantino, ODChief Clinical & Regulatory Officer
OISMay 5, 2015
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
Qua
lity,
50
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)
-3-2.5-2-1.5-1-0.50
0
0.05
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0.15
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0.25
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Cylinder Defocus Curves IC-8 IOL vs Monofocal IOL
IC-8Monofocal
Cylinder Defocus
Chan
ge in
Visu
al A
cuity
(log
MAR
)
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
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
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
THANK YOU
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