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Nicholas Tarantino, OD
Chief Clinical & Regulatory Officer
OIS
May 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
2
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 & Metrics
KAMRA® 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%
3
Small Aperture Comes to the United States
KAMRA® 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
4
The KAMRA® Inlay Pull Through Effect
Accelerating Growth in Refractive Practices
Average % Growth Since Adding the KAMRA Inlay
23%
67%
27%
10%
0%
20%
40%
60%
80%
100%
LASIK Mul focal IOL Toric IOL Accommoda ve
IOL
5
IC-8™ IOL Specifications
Approved 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 Material
Single-piece hydrophobic acrylic
Mask
PVDF & nano-particles of carbon
1.36mm aperture
3.23mm total diameter
3200 microperforations
5 microns thick
6
Binocular Defocus Curves:
Distance-corrected and Target-corrected IC-8™ IOL with Monofocal IOL
-0.3
-0.2
-0.1
0.0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
-4-3-2-1012
VisualAcuity(logMAR)
Defocus (D)
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)
• 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
7
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
8
Competitive Comparison of IOL Image Quality
IC-8™ IOL has the broadest range of high quality continuous functional vision
0.00
0.10
0.20
0.30
0.40
0.50
0.60
0.70
0.80
0.90
1.00
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
MTFImageQuality,50lp/mm
Relative Defocus (Diopter)
-1.0 -0.5 0.0 0.5 1.0 1.5 2.0 2.5 3.0
Unusable
Vision
9
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 Imaging
IC-8™ IOL vs. Symfony IOL & AcriLisa Trifocal IOL
10
Tolerance to Uncorrected Astigmatism
(IC-8™ Eyes vs. Monofocal Eyes)
0
0.05
0.1
0.15
0.2
0.25
0.3
-3-2.5-2-1.5-1-0.50
ChangeinVisualAcuity(logMAR)
Cylinder Defocus
Cylinder Defocus Curves
IC-8 IOL vs Monofocal IOL
IC-8
Monofocal
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
11
Therapeutic Uses for the IC-8™ IOL
Positive 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 Dick
12
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 Solution
Presbyopia 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
14
Extended Depth-of-Focus with Small Aperture Optics
THANK YOU
15

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SPOTLIGHT ON THE PREMIUM CHANNEL – AcuFocus

  • 1. Nicholas Tarantino, OD Chief Clinical & Regulatory Officer OIS May 5, 2015
  • 2. 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 2
  • 3. 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 & Metrics KAMRA® 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% 3
  • 4. Small Aperture Comes to the United States KAMRA® 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 4
  • 5. The KAMRA® Inlay Pull Through Effect Accelerating Growth in Refractive Practices Average % Growth Since Adding the KAMRA Inlay 23% 67% 27% 10% 0% 20% 40% 60% 80% 100% LASIK Mul focal IOL Toric IOL Accommoda ve IOL 5
  • 6. IC-8™ IOL Specifications Approved 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 Material Single-piece hydrophobic acrylic Mask PVDF & nano-particles of carbon 1.36mm aperture 3.23mm total diameter 3200 microperforations 5 microns thick 6
  • 7. Binocular Defocus Curves: Distance-corrected and Target-corrected IC-8™ IOL with Monofocal IOL -0.3 -0.2 -0.1 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 -4-3-2-1012 VisualAcuity(logMAR) Defocus (D) 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) • 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 7
  • 8. 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 8
  • 9. Competitive Comparison of IOL Image Quality IC-8™ IOL has the broadest range of high quality continuous functional vision 0.00 0.10 0.20 0.30 0.40 0.50 0.60 0.70 0.80 0.90 1.00 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 MTFImageQuality,50lp/mm Relative Defocus (Diopter) -1.0 -0.5 0.0 0.5 1.0 1.5 2.0 2.5 3.0 Unusable Vision 9
  • 10. 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 Imaging IC-8™ IOL vs. Symfony IOL & AcriLisa Trifocal IOL 10
  • 11. Tolerance to Uncorrected Astigmatism (IC-8™ Eyes vs. Monofocal Eyes) 0 0.05 0.1 0.15 0.2 0.25 0.3 -3-2.5-2-1.5-1-0.50 ChangeinVisualAcuity(logMAR) Cylinder Defocus Cylinder Defocus Curves IC-8 IOL vs Monofocal IOL IC-8 Monofocal 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 11
  • 12. Therapeutic Uses for the IC-8™ IOL Positive 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 Dick 12
  • 13. 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
  • 14. Small Aperture Solution Presbyopia 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 14 Extended Depth-of-Focus with Small Aperture Optics

Editor's Notes

  1. We are really pleased with a reorder rate of 85%. It can never be 100% because of the staggered start. Those who just started need time to reorder. An average reorder time of one month means that sites are averaging at least 10 per month
  2. 25 Accounts Surveyed (20 US, 5 OUS) Reinvigorates practices by bringing back previous refractive patients who have become presbyopic Advertising spent on KAMRA brings patients in and the is compounded by patients who qualify for other procedures
  3. 0.27 asphericity
  4. Combination of high ABBE # and small aperture optics provides us with the highest quality of continuous functional vision over the broadest range Start describing here how we have better image quality – no free lunch We know you and competitors are working on new products – including refractive error tolerance May be able to increase range of defocus using spherical aberration but it will be at a cost of image quality What is the minimally acceptable MTF value Function of spatial frequency – show 50 lp because ISO standard At 100 lp it will be similar – didn’t bring the data