SPOTLIGHT ON THE PREMIUM CHANNEL – AcuFocus

SPOTLIGHT ON THE PREMIUM CHANNEL – AcuFocus

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  Nicholas Tarantino, OD ChiefClinical & Regulatory Officer OIS May 5, 2015
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  KAMRA® Inlay (Ages45-60) 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
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  KAMRA® Inlay CommercialSuccess 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
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  Small Aperture Comesto 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
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  The KAMRA® InlayPull 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
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  IC-8™ IOL Specifications Approvedin 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
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  Binocular Defocus Curves: Distance-correctedand 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
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  IC-8™ IOL VisualAcuity 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
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  Competitive Comparison ofIOL 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
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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 Imaging IC-8™ IOL vs. Symfony IOL & AcriLisa Trifocal IOL 10
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  Tolerance to UncorrectedAstigmatism (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
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  Therapeutic Uses forthe 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
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  What Does AllThis 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 Solution Presbyopiaand 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
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  THANK YOU 15