2/15/18

Myopia, The Refracve Market and Phakic IOLs in Modern Refracve Surgery

David W. Friess, OD, FAAO

Head of Global Professional Affairs Staar Surgical Company

President, OCCRS Optometric Cornea, Cataract and Refracve Society

Financial Interest Disclosures

• STAAR Surgical Co. – Employee, Shareholder

• Opmus Clinical Partners LLC – President/Owner

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Phakic IOL Product Informaon

• ATTENTION: Reference the Visian ICL™ and Verisyse™ Product Informaon for a complete lisng of indicaons, warnings and precauons.

Refracve Market Stascs

• Includes US/Canada/Mexico LASIK, PRK/surface ablaon, phakic IOLs, and refracve lens exchange • 2007 1M+ refracve procedures • 2013 600,0001 • 2015 vision correcon market in the US2: – Over 60% require vision correcon (nearly 200M people) – Spectacles, contact lenses – Refracve surgery penetraon remains at less than 3% – 600,000 refracve procedures in 2015 • 2016 Q1 Market Scope: – 172,000 refracve procedures

1. Cataract & Refracve Surgery Today, July 2014 2. The Vision Council. hps://www.thevisioncouncil.org/topic/problems-condions/adults

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Refracve Opportunity: Boomers vs. Millennials

• US Census Bureau Esmates1: – 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. hp://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 Instute (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

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Key Myopic Treatment Goals

• Desire treatments with… – High Safety Index Postop BCVA/Preop BCVA – High Efficacy Index Postop UCVA/ Preop BCVA – Aempted 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 refracons – High paent sasfacon

Phakic IOLs

• Variable materials – Plasc – Silicone – Collagen (Collamer) - STAAR Visian ICL • Variable designs Anterior Chamber Iris Supported Posterior Chamber ● Acrysof, Alcon ● Arsan, 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

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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 opc

hp://abbomedicalopcs.com/products/cataract/refracve-iols/verisyse-phakic-iol Louis J. Catania © 2007 Nicolitz Eye Consultants

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Verisyse® Phakic IOL Product Labeling

• Indicaon: • Verisyse® intraocular lenses are indicated for the reducon 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 asgmasm 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 refracon for the prior 6 months, as demonstrated by spherical equivalent change of less than or equal to 0.50 diopters.

hp://abbomedicalopcs.com/products/cataract/refracve-iols/verisyse-phakic-iol

Louis J. Catania © 2007 Nicolitz Eye Consultants

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Visian ICL™ V4 Design Posterior Chamber Phakic IOL

ICL Design

• Posterior Chamber Phakic IOL • Hapcs placed in sulcus - stability • Opc Vault by design – 500 um over the central crystalline lens • Orientaon marks for proper placement and alignment in injector • Small incision refracve surgery • Foldable and injectable through a 3.5mm or less incision

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COLLAGEN COPOLYMER

Collamer Summary

• Collagen matrix • Hydrophilic • Biocompability • Refracve index = 1.44 • Elasc: Gentle unfolding • Tensile strength: Strong, resists tearing • UV blocking chromophore • Lathe cut design • Stored in BSS

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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 Direcons for Use (DFU)

Orientaon Marks Direcon of Implantaon Trailing Le

Leading Right

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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 correcon of myopia in adults with myopia ranging from -3.0D to ≤-15.0D with less than or equal to 2.5D of asgmasm at the spectacle plane; 2. For the reducon of myopia in adults with myopia ranging from greater than -15.0D to -20.0D with less than or equal to 2.5D of asgmasm at the spectacle plane; 3. With an anterior chamber depth (ACD) of 3.00mm or greater, and a stable refracve history (within 0.5 Diopter for 1 year prior to implantaon).

STAAR FDA MICL Direcons for Use (DFU)

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Visian ICL™ (Implantable Collamer Lens) for Myopia For the correcon / reducon of moderate to high myopia

• FDA Direcons for Use (DFU) Device Descripon

STAAR FDA MICL Direcons 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 Direcons for Use (DFU)

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Packer, 2016: Meta-Analysis of ICL Papers

• Broad range of correcons • High quanty of vision • High quality of vision • Low incidence of complicaons with good paent selecon • High benefit to risk rao

Packer M. Meta-analysis and review: effecveness, 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

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30

20

10

0 Post ICL (n=34) Other Refracve 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, Ellio DB. A quality of life comparison of people wearing spectacles or contact lenses or having undergone refracve surgery. J Refract Surg 2006; 22:19–27.

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WELL ESTABLISHED BENEFITS

• Efficacy Index: Post-op UCVA/Pre-op • Long-Term (5yr) Refracve 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 arficial 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 Convenonal ICL) Implantaon for Moderate to High Myopia and Myopic Asgmasm. 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. hp://www.ophthalmologymanagement.com/arcleviewer.aspx?arcleid=105346 (Accessed August 6, 2016).

US MILITARY WARFIGHTERS1

• Retrospecve, intervenonal consecuve 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 Retrospecve Analysis of Early Clinical Outcomes of the Visian ICL. J Refract Surg. 2011;27(7):473-481.

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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 Retrospecve 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 Retrospecve Analysis of Early Clinical Outcomes of the Visian ICL. J Refract Surg. 2011;27(7):473-481.

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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. Visual Performance aer Implantable Collamer Lens Implantaon and Wavefront-Guided Laser In Situ Keratomileusis for High Myopia. Am J Ophthalmol 2009;148:164-170.

VISIAN ICL™ VS. WFG-LASIK1: CONTRAST SENSITIVITY (LOW TO MODERATE MYOPIA)

• ICL: Significant Increase (p < 0.001) • WFG-LASIK: No change (p = 0.11)

1. Kamiya K, Igarashi A, Shimizu K, Matsumura K, Komatsu M. Visual Performance Aer Posterior Chamber Phakic Intraocular Lens Implantaon and Wavefront- Guided Laser In Situ Keratomileusis for Low to Moderate Myopia. Am J Ophthalmol 2012;153:1178-1186.

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Publicaon Review: A prospecve comparison of phakic collamer lenses and wavefront-opmized laser-assisted in situ keratomileusis for correcon of myopia.

Parkhurst GD. A prospecve comparison of phakic collamer lenses and wavefront-opmized laser-assisted in situ keratomileusis for correcon of myopia. Clin Ophthalmol. 2016 Jun 29;10:1209-15.

Study Methods

• Refracve Surgery Center, Carl R Darnall Army Medical Center, Fort Hood, TX • Prospecve, non-randomized comparison of 48 military personnel (95 eyes) who underwent either Visian ICL implantaon or wavefront- opmized LASIK with WaveLight Allegreo Eye-Q 400 Hz excimer laser system – All the paents completed the 3-month follow-up period • Subjects were included with: – Stable refracve error (change of spherical equivalent < 0.50 D for at least 1 year) – Myopia > −3.00 D (range: –3.00 D to –11.50 D) with asgmasm < 3.00 D

Parkhurst GD. A prospecve comparison of phakic collamer lenses and wavefront-opmized laser- assisted in situ keratomileusis for correcon of myopia. Clin Ophthalmol. 2016 Jun 29;10:1209-15.

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Study Methods

• Age was comparable between the two groups – ICL = 27.6 ± 7.3 years (range = 19 – 46 years) – LASIK = 27.0 ± 5.9 years (range = 20 – 41 years) • No significant difference between two groups in preoperave spherical equivalent – ICL = −6.10 ± 1.76 D (range: −3.25 D to −11.50 D) – LASIK = −6.04 ± 1.72 D (range: −3.00 D to −9.50 D) • Scotopic pupil diameters were also comparable – ICL = 6.37 ± 1.01 mm (range = 4.5 – 8 mm) – LASIK = 6.23 ± 0.88 mm (range = 4 – 8 mm)

Parkhurst GD. A prospecve comparison of phakic collamer lenses and wavefront-opmized laser- assisted in situ keratomileusis for correcon of myopia. Clin Ophthalmol. 2016 Jun 29;10:1209-15.

Study Methods

• Rabin Super Vision Test – Precision Vision, LaSalle, IL, USA – High-contrast visual acuity – Leer contrast sensivity

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Study Methods

• Rabin Super Vision Test was used to compare the visual acuity and CS in each group under normal and low light condions, using a filter for simulated vision through night vision goggles (NVG). – NVGs present parcularly challenging viewing condions • low luminance • loss of color discriminaon • diminished contrast – Tesng was conducted with best spectacle correcon, first using NVG with low-luminance filter, then without filter (method used to prevent learning)

Parkhurst GD. A prospecve comparison of phakic collamer lenses and wavefront-opmized laser- assisted in situ keratomileusis for correcon of myopia. Clin Ophthalmol. 2016 Jun 29;10:1209-15.

Study Results

• All surgeries were unevenul, and no vision-threatening complicaons were seen throughout the observaon period • Both groups were comparable with respect to preoperave visual acuies and contrast sensivies

Parkhurst GD. A prospecve comparison of phakic collamer lenses and wavefront-opmized laser- assisted in situ keratomileusis for correcon of myopia. Clin Ophthalmol. 2016 Jun 29;10:1209-15.

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Study Results: Super Vision Acuity (SVa)

• Stascally significant improvement from preoperave-to-postoperave level observed in both groups. • At 3 months, mean improvements in SVa (LogMAR) in the ICL and LASIK groups were comparable (P=0.154; error bars represent SD).

Parkhurst GD. A prospecve comparison of phakic collamer lenses and wavefront-opmized laser- assisted in situ keratomileusis for correcon of myopia. Clin Ophthalmol. 2016 Jun 29;10:1209-15.

Study Results: Super Vision Contrast (SVc)

• Postoperave improvement from preoperave levels was stascally significant in both groups. • Stascally significant greater improvement for normal illuminaon and night vision simulaon in the ICL compared to LASIK group.

Parkhurst GD. A prospecve comparison of phakic collamer lenses and wavefront-opmized laser- assisted in situ keratomileusis for correcon of myopia. Clin Ophthalmol. 2016 Jun 29;10:1209-15.

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Study Results: Super Vision Acuity with Goggles (SVaG)

• At 3 months, mean improvement in SVaG (LogMAR ) in the ICL group was stascally significantly greater than the mean improvement in the LASIK group (P=0.032*; error bars represent SD).

Parkhurst GD. A prospecve comparison of phakic collamer lenses and wavefront-opmized laser- assisted in situ keratomileusis for correcon of myopia. Clin Ophthalmol. 2016 Jun 29;10:1209-15.

Study Results: Super Vision Contrast with (low luminance) Goggles (SVcG)

• At 3 months, mean improvement in SVcG (LogCS) was stascally significantly greater in the ICL group as compared to the LASIK group (P=0.024*; error bars represent SD).

Parkhurst GD. A prospecve comparison of phakic collamer lenses and wavefront-opmized laser- assisted in situ keratomileusis for correcon of myopia. Clin Ophthalmol. 2016 Jun 29;10:1209-15.

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Conclusion

• In this study, low-luminance visual acuity and low-luminance CS significantly improved following ICL implantaon, and the improvements were significantly beer than those observed aer wavefront-opmized LASIK.

Parkhurst GD. A prospecve comparison of phakic collamer lenses and wavefront-opmized laser- assisted in situ keratomileusis for correcon of myopia. Clin Ophthalmol. 2016 Jun 29;10:1209-15.

AS A COMPREHENSIVE REFRACTIVE PRACTICE…

...your responsibility is to understand the potenal risks1:

• Early IOP Spike • Late Cataract

…and be prepared to manage them.

1. STAAR FDA MICL Direcons for Use (DFU)

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EARLY IOP SPIKE

• FDA Study MICL DFU6: “Raised IOP Requiring Intervenon” § 3.2% (n = 17/526) addional LPI § 0.6% (n = 3/526) repeat irrigaon and aspiraon at 1 day post-op • Migaon/Management6: § Important to monitor IOP at 24 hours postoperavely § Importance of patent LPIs § Thorough removal of OVD • Literature: § Incidence of pupillary block 0.01, 3, 4, 5 – 0.7%2

1. Igarashi A, Shimizu K, Kamiya K. Eight-year follow-up of posterior chamber phakic intraocular lens implantaon for moderate to high myopia. Am J Ophthalmol 2014; 157: 532–9. 2. Lee JS, Kim YH, Park SK, Lee SU, Park YM, Lee JH, Lee JE. Long-term clinical results of posterior chamber phakic intraocular lens implantaon to correct myopia. Clin Experiment Ophthalmol. 2015 Dec 12. doi: 10.1111/ceo.12691. [Epub ahead of print] 3. Higueras-Esteban A, Orz-Gomariz A, Guérrez-Ortega R, Villa-Collar C, Abad-Montes JP, Fernandes P, González-Méijome JM. Intraocular pressure aer implantaon of the Visian Implantable Collamer Lens With CentraFLOW without iridotomy. Am J Ophthalmol. 2013 Oct;156(4):800-5 4. 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 arficial hole. Am J Ophthalmol. 2014 Jun;157(6):1136-43. 5. 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. 6. STAAR FDA MICL Direcons for Use (DFU)

MULTIPLE ETIOLOGIES OF CATARACT

Patient Related Factors1 Surgeon Related Factors1 Visian ICL™ Related Factors1

Age2,3 Surgical trauma Insufficient Vault2,4,5

Refractive status3 • Early onset (< 3M) • Disturbance of aqueous flow1 associated with surgical • Interference with lens trauma metabolism1

Anterior Subcapsular Cataract (ASC)

1. Chen et al. Metaanalysis of cataract development aer PIOL surgery. J Cataract Refract Surg 2008; 34:1181–1200. 2. Gonvers et al. Implantable contact lens for moderate to high myopia: relaonship of vaulng to cataract formaon. J Cataract Refract Surg 2003; 29: 918–24 3. Sanders DR. Anterior subcapsular opacies and cataracts 5 years aer surgery in the visian implantable collamer lens FDA trial. J Refract Surg. 2008 Jun;24(6):566-70 4. Schmidinger et al. Long-term changes in posterior chamber phakic intraocular Collamer lens vaulng in myopic paents. Ophthalmology 2010; 117:1506–1511 5. Alfonso et al, Central vault aer phakic intraocular lens implantaon: Correlaon with anterior chamber depth, white-to-white distance, spherical equivalent, and paent age J Cataract Refract Surg 2012; 38:46–53

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INCIDENCE OF MICL/V4 ASC CATARACTS

Clinically Incidence of V4 ASC Cataracts MRSE Follow ASC and Cataract Surgery N Significant (D) Up 18 ASC 16 14 STAAR FDA MICL DFU 526 -10.06 3 years 0.4% 12 10 % Kamiya Arch Ophthalmol 56 -9.83 4 years 1.8% 8 2009 6 4 Sanders J Refract Surg 2007 311 -10.06 5 years 1.3% 2 0 Alfonso J Cataract Refract 0 1 2 3 4 5 6 7 8 9 188 -10.76 5 years 0.5% Surg 2011 Years Alfonso J Cataract Refract 1531 -7.27 5 years 1.4% MICL DFU Kamiya 2009 Sanders Surg 2015 Alfonso 2011 Alfonso 2015 Brar 2015 Brar EC Ophthalmology 615 NR 5 years 0.7% Schmidinger 2010 Lee 2015 2015

Schmidinger 84 -16.40 6 years 17% Ophthalmology 2010

Lee Clin Exp Ophthalmol 281 -8.74 7 years 1.8% 2015

Phakic IOLs for Myopia

• Well established benefits • Low rate of complicaons • Broad range of treatment • Preservaon of corneal or lencular ssue • High paent sasfacon and improvement in quality of life

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Summary: Myopia, The Refracve Market and Phakic IOLs in Modern Refracve Surgery

• Myopia affects a large and growing demographic in need of vision correcon • Refracve surgery is a viable opon for many paents • Phakic IOLs have a long history with high benefit to risk rao • Keys include proper paent selecon, meculous surgery and good clinical follow-up to ensure paent sasfacon and quality of life is delivered

Thank you

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