2/15/18 Myopia, The Refrac5ve Market and Phakic IOLs in Modern Refrac5ve Surgery David W. Friess, OD, FAAO Head of Global Professional Affairs Staar Surgical Company President, OCCRS Optometric Cornea, Cataract and Refrac5ve Society Financial Interest Disclosures • STAAR Surgical Co. – Employee, Shareholder • Opmus Clinical Partners LLC – President/Owner 1 2/15/18 Phakic IOL Product Informaon • ATTENTION: Reference the Visian ICL™ and Verisyse™ Product Informaon for a complete lis5ng of indicaons, warnings and precau5ons. Refrac5ve Market Stas5cs • Includes US/Canada/Mexico LASIK, PRK/surface ablaon, phakic IOLs, and refrac5ve lens exchange • 2007 1M+ refrac5ve procedures • 2013 600,0001 • 2015 vision correc5on market in the US2: – Over 60% require vision correc5on (nearly 200M people) – Spectacles, contact lenses – Refrac5ve surgery penetraon remains at less than 3% – 600,000 refrac5ve procedures in 2015 • 2016 Q1 Market Scope: – 172,000 refrac5ve procedures 1. Cataract & Refrac5ve Surgery Today, July 2014 2. The Vision Council. heps://www.thevisioncouncil.org/topic/problems-condi5ons/adults 2 2/15/18 Refrac5ve Opportunity: Boomers vs. Millennials • US Census Bureau Es5mates1: – 75.4 million Baby Boomers in 2014. Ages 51 to 69 in 2015. – 74.8 million Millennials in 2014. Ages 18 to 34 in 2015. – By 2015, Millennials increased to 75.3 million and became the biggest group. 1. hep://www.pewresearch.org/fact-tank/2015/01/16/this-year-millennials-will-overtake-baby-boomers/ Myopia Research and Coverage in Mainstream Media • Huffington Post, 03/22/2016: Nearsightedness Has a Far-Reaching Impact As the Myopia Epidemic Spreads Around the Globe – References new research from the Brien Holden Vision Ins5tute (AUS) study on the prevalence of myopia • Holden BA, et al. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May; 123(5):1036-42. – Myopia is projected to affect almost half of the world’s populaon by 2050 — a sevenfold increase – 5 billion with myopia – 1 billion with high myopia (>-6D) – United States and Canada increase to 260 million, or close to half of the populaon, up from 89 million in 2000 – High myopia cases increase by five mes to 66 million 3 2/15/18 Key Myopic Treatment Goals • Desire treatments with… – High Safety Index Postop BCVA/Preop BCVA – High Efficacy Index Postop UCVA/ Preop BCVA – Aeempted vs. Achieved Rx - accurate and stable – Low rate of complicaons – Preserve corneal integrity and lens for future procedures – Low dry eye risk – Similar treatment across a broad range of refrac5ons – High paent sasfac5on Phakic IOLs • Variable materials – Plas5c – Silicone – Collagen (Collamer) - STAAR Visian ICL • Variable designs Anterior Chamber Iris Supported Posterior Chamber ● Acrysof, Alcon ● Ar>san, Ophtec ● PRL, Ciba ● GBR,IOL Tech ● Verisyse, AMO ● Visian ICL, STAAR ● Kelman Duet, Tekia ● MemoryLens, Ciba ● NewLife, IOL Tech ● NuVita, B&L ● ThinOptX ● Vision Membrane ● 6H2, Oll 4 2/15/18 FDA Approvals for Phakic IOLs for Myopia • 2004 – Verisyse® anterior chamber phakic IOL (AMO, Inc.) • 2005 – Visian ICL™ posterior chamber phakic IOL (STAAR Surgical Co.) www.allaboutvision.com/visionsurgery/implantable-lenses.htm Verisyse™ Anterior chamber iris fixated phakic IOL (AMO, Inc.) 8.5mm one piece PMMA 5.0mm and 6.0mm op5c hep://abboemedicalop5cs.com/products/cataract/refrac5ve-iols/verisyse-phakic-iol Louis J. Catania © 2007 Nicolitz Eye Consultants 5 2/15/18 Verisyse® Phakic IOL Product Labeling • Indicaon: • Verisyse® intraocular lenses are indicated for the reduc5on or eliminaon of myopia in adults with myopia ranging from -5.0 to -20.0 diopters with less than or equal to 2.5 diopters of as5gmasm at the spectacle plane and whose eyes have an anterior chamber depth greater than or equal to 3.2 millimeters; and, paents with documented stability of refrac5on for the prior 6 months, as demonstrated by spherical equivalent change of less than or equal to 0.50 diopters. hep://abboemedicalop5cs.com/products/cataract/refrac5ve-iols/verisyse-phakic-iol Louis J. Catania © 2007 Nicolitz Eye Consultants 6 2/15/18 Visian ICL™ V4 Design Posterior Chamber Phakic IOL ICL Design • Posterior Chamber Phakic IOL • Hap5cs placed in sulcus - stability • Op5c Vault by design – 500 um over the central crystalline lens • Orientaon marks for proper placement and alignment in injector • Small incision refrac5ve surgery • Foldable and injectable through a 3.5mm or less incision 7 2/15/18 COLLAGEN COPOLYMER Collamer Summary • Collagen matrix • Hydrophilic • Biocompability • Refrac5ve index = 1.44 • Elas5c: Gentle unfolding • Tensile strength: Strong, resists tearing • UV blocking chromophore • Lathe cut design • Stored in BSS 8 2/15/18 Peripheral Iridotomy • Two YAG iridotomies (0.5mm; placed superiorly, 90 degrees apart) should be performed 2 to 3 weeks prior to surgery with confirmaon of the patency of the iridotomies prior to lens implantaon. STAAR FDA MICL Direc5ons for Use (DFU) Orientaon Marks Direcon of Implantaon Trailing Lew Leading Right 9 2/15/18 Visian ICL – Implantable Collamer Lens Indicaons for Use • The Visian ICL is indicated for use in adults 21-45 years of age: 1. For the correc5on of myopia in adults with myopia ranging from -3.0D to ≤-15.0D with less than or equal to 2.5D of as5gmasm at the spectacle plane; 2. For the reduc5on of myopia in adults with myopia ranging from greater than -15.0D to -20.0D with less than or equal to 2.5D of as5gmasm at the spectacle plane; 3. With an anterior chamber depth (ACD) of 3.00mm or greater, and a stable refrac5ve history (within 0.5 Diopter for 1 year prior to implantaon). STAAR FDA MICL Direc5ons for Use (DFU) 10 2/15/18 Visian ICL™ (Implantable Collamer Lens) for Myopia For the correc5on / reduc5on of moderate to high myopia • FDA Direcons for Use (DFU) Device Descripon STAAR FDA MICL Direc5ons for Use (DFU) Contraindicaons • The Visian ICL is contraindicated in paents: 1. With an anterior chamber depth (ACD) of <3.00mm; 2. With anterior chamber angle less than Grade III as determined by gonioscopic examinaon; 3. Who are pregnant or nursing; 4. Less than 21 years of age; 5. Who do not meet the minimum endothelial cell density. STAAR FDA MICL Direc5ons for Use (DFU) 11 2/15/18 Packer, 2016: Meta-Analysis of ICL Papers • Broad range of correc5ons • High quan5ty of vision • High quality of vision • Low incidence of complicaons with good paent selec5on • High benefit to risk rao Packer M. Meta-analysis and review: effec5veness, safety, and central port design of the intraocular collamer lens. Clin Ophthalmol. 2016; 10: 1059–1077. VISIAN ICL™ QUALITY OF LIFE VS. GLASSES, CONTACT LENSES AND LASIK QIRC Scores 60 53.8 50.2 50 46.7 44.1 40 30 20 10 0 Post ICL (n=34) Other Refrac5ve Surgery Contact Lenses (n=104) Spectacles (n=104) Ieong et al (n=104) Pesudovs et al 1. Ieong A, Hau, S, Rubin GS, Allan, B. Quality of Life in High Myopia before and aer Implantable Collamer Lens Implantaon. Ophthalmology 2010; 117:2295-2300 2. Pesudovs K, Garamendi E, Ellioe DB. A quality of life comparison of people wearing spectacles or contact lenses or having undergone refrac5ve surgery. J Refract Surg 2006; 22:19–27. 12 2/15/18 WELL ESTABLISHED BENEFITS • Efficacy Index: Post-op UCVA/Pre-op • Long-Term (5yr) Refrac5ve Stability4 BCVA1 Procedure Efficacy IndeX Visian ICL™ 0.96 – 1.011, 2, 3 • Seeing well “right off the table”5 1. UCVA = Uncorrected Visual Acuity, BCVA = Best Corrected Visual Acuity 2. Lisa C, Alfonso JF, Alfonso-Bartolozzi B, Fernández-Vega L, Pérez-Vives C, Montés-Micó R. Collagen copolymer posterior chamber phakic intraocular lens supported by the ciliary sulcus to treat myopia: one-year follow-up. J Cataract Refract Surg. 2015 Jan;41(1):98-104. 3. Huseynova T, Ozaki S, Ishizuka T, Mita M, Tomita M. Comparave study of 2 types of implantable collamer lenses, 1 with and 1 without a central ar5ficial hole. Am J Ophthalmol. 2014 Jun;157(6):1136-43. 4. Shimizu K, Kamiya K, Igarashi A, Kobashi H. Long-Term Comparison of Posterior Chamber Phakic Intraocular Lens With and Without a Central Hole (Hole ICL and Conven5onal ICL) Implantaon for Moderate to High Myopia and Myopic As5gmasm. Medicine. 2016 Apr;95(14):e3270. 5. Steven S. Lane, MD, quoted in Helzner J, Phakic IOLs: Ready for a Breakthrough? Ophthalmology Management March 1, 2011. hep://www.ophthalmologymanagement.com/ar5cleviewer.aspx?ar5cleid=105346 (Accessed August 6, 2016). US MILITARY WARFIGHTERS1 • Retrospec5ve, interven5onal consecu5ve case series assessing short-term (3 months) clinical outcomes aer Visian ICL™ implantaon in US military warfighters • 135 eyes of 69 paents who were not good candidates for laser vision correcon • Age: 30.9 +/- 6.6 years • Pre-Op MRSE: -6.00 +/- 1.92 D (range: -2.63 to -11.50 D) 1. Parkhurst GD, Psolka M, Kezirian GM. Phakic Intraocular Lens Implantaon in United States Military Warfighters: A Retrospec5ve Analysis of Early Clinical Outcomes of the Visian ICL. J Refract Surg. 2011;27(7):473-481. 13 2/15/18 US MILITARY WARFIGHTERS1 • ICL Predictability: • 90% +/- 0.50 D • 99% +/- 0.75 D 1. Parkhurst GD, Psolka M, Kezirian GM. Phakic Intraocular Lens Implantaon in United States Military Warfighters: A Retrospec5ve Analysis of Early Clinical Outcomes of the Visian ICL. J Refract Surg. 2011;27(7):473-481. US MILITARY WARFIGHTERS1 • ICL Visual Acuity 1. Parkhurst GD, Psolka M, Kezirian GM. Phakic Intraocular Lens Implantaon in United States Military Warfighters: A Retrospec5ve Analysis of Early Clinical Outcomes of the Visian ICL. J Refract Surg. 2011;27(7):473-481. 14 2/15/18 VISIAN ICL™ VS. WFG-LASIK1: CONTRAST SENSITIVITY (HIGH MYOPIA) • ICL: Significant Increase (p < 0.001) • WFG-LASIK: Significant decrease (p = 0.001) 1. Igarashi A, Kamiya K, Shimizu K, Komatsu M.