Intraocular Approaches to Presbyopia

BREAKOUT SESSION: INNOVATIVE INTRAOCULAR APPROACHES TO ADDRESS PRESBYOPIA

YARI STEVEN MODERATED BY: MITCHELL SMATHERS ACUFOCUS PERFECT LENS

ELIZABETH YEU, MD VIRGINIA EYE CONSULTANTS/EASTERN RAMGOPAL MAX VIRGINIA MEDICAL SCHOOL RAO WOLF, MID LENSGEN ALCON

www.ois.net #OISAAO AAO 2018 - Chicago The Perfect Lens Device Examples of Technology Application

• Alter sphere, cylinder, sphere and cylinder, asphericity, add multi-focality, potentially remove multi-focality • Works on any acrylic IOL hydrophobic/hydophilic lens • Adjust IOL multiple times • Correct issues caused by tilt and decentration of IOL • No cutting or ablation of any tissue • In-office procedure • Takes 60 seconds or less • Potentially corrects higher order aberrations Enhancement of Hydrophilicity by Femtosecond Laser Excitation Area of Femtosecond Laser Focus 2D RIS Lens in IOL Monofocal IOL to Multifocal Monofocal to Multifocal to Monofocal Refractive Multifocal vs Diffractive Multifocal

Refractive Diffractive Thank you Yari Mitchell

V.P. Medical Affairs & Business Strategy OIS@AAO 2018

THE IC- 8 ® IOL Small Aperture Optics

Clear extended range of focus

The IC-8 IOL is not approved for use in the United States THE IC- 8 ® IOL True Extended Depth of Focus

Presbyopic Eye Binocular IC-8 and Monofocal IOL

-0.20

-0.10 1.25 0.00 1.00 0.10 0.80

0.20 0.63

0.30 0.50

0.40

0.50

LogMAR Visual Acuity 0.60

0.70 3.00 D 0.80 Functional Range of 0.90 Vision 1.00

1.10

1.20 1.00 0.50 0.00 -0.50 -1.00 -1.50 -2.00 -2.50 -3.00 -3.50 -4.00

Far Intermediate Near Infinity 80 cm 40 cm

*Presbyopic patient defocus curve – KAMRA Inlay PMA (N=114) ** Binocular Target-corrected defocus curve at 6 months (N=12) IC-8 IOL is not approved for use in the United States THE IC- 8 ® IOL Sustained Range of Vision

Binocular UCVA -0.20

-0.10

0.00 20/20 0.10 20/25 0.20 20/32

0.30

LogMAR 0.40

0.50

0.60

0.70

0.80 Mon 24 Mon 1 Mon 3 Mon 6 (N=52)Mon 12 (N=108) (N=107) (N=105) (N=52)

Far Intermediate Near

Mean IC-8 IOL MRSE: -0.48 D at 24 months Mean Monofocal IOL MRSE: 0.08 D at 24 Months The IC-8 IOL is not approved for use in the United States THE IC- 8 ® IOL Refractive Target Landing Zone

1.00 D 0.75 D 0.50 D

IC-8 IOL! Monofocal IOL! Multifocal IOL!

Data from the European Post-Market Study on IC-8 IOL Braga-Mele et al. J Cataract Refract Surge 2014; 40:313-322 The IC-8 IOL is not approved for use in the United States THE IC- 8 ® IOL Alignment-Free Corneal Astigmatism Correction

Cylinder Tolerance

0.01 0.0 0.06 0.09 0.09 0.1 20/20! 0.2 * 0.22 0.23 20/25! 0.28 * 0.3 0.32 20/32! 0.37 LogMAR 0.4

0.5

0.6 UCDVA UCIVA UCNVA Visual Acuity

Less than 0.75 D (N=114) 0.76 D to 1.5 D (N=25) More than 1.50 D (N=6)

* Indicates Statistically Significant, Data from the European Post-Market Study on IC-8 IOL The IC-8 IOL is not approved for use in the United States SMALL APERTURE TECHNOLOGY The IC-8® Intraocular Lens

Cataract Relief

Depth of Focus

Quality of Vision

Refractive Forgiveness

360o Alignment Free

The IC-8 IOL is not approved for use in the United States THE IC- 8 ® IOL OUS Commercial Utilization

Name

PremiumPremium MonovisionMonovision RangeRange of of VisionVision RescueRescue BilateralBilateral IrregularIrregular CorneaCornea IrregularIrregular CorneaCornea DysphotopsiaDysphotopsia ManagementManagement Future DevelopmentDevelopment RangeEDOF of Vision Upgrade Upgrade

The IC-8 IOL is not approved for use in the United States THE IC- 8 ® IOL Evolving Cataract Surgery

3.0% 0.0% 3.9%

0.0%

92.3%

Monofocal Toric Presbyopia-correcting Phakic Other

Market Scope 2016 IOL Report The IC-8 IOL is not approved for use in the United States THE IC- 8 ® IOL Disrupting an Underserved Market

3.0% 0.0% 3.9%

0.0%

11% Irregular Cornea Segment*

92.3%

2016 Market Scope IOL Report – US IOL Adoption Monofocal Toric Presbyopia-correcting Phakic Other The IC-8 IOL is not approved for use in the United States *Estimate based on prevalence of LVC, corneal aberrations > 0.5 microns and keratoconus and reported 2016 US IOL adoption data from the 2016 Market Scope IOL Report THE IC- 8 ® IOL Who is the Irregular Cornea Patient?

Post--RK Post-LASIK Keratoconus Iris Trauma David Kent, MD Sathish Srinivasan, MD Omid Kermani, MD Burkhard Dick, MD

The IC-8 IOL is not approved for use in the United States THE IC- 8 ® IOL Expanding Scientific References

The IC-8 IOL is not approved for use in the United States

INNOVATIVE INTRAOCULAR APPROACHES TO ADDRESS PRESBYOPIA

MAX WOLF GLOBAL HEAD, INTRAOCULAR LENSES

OCTOBER, 2018 DISCLOSURES

• Alcon employee • Will only discuss publicly disclosed information and products approved in the US • Will not be sharing information or data regarding any ongoing trials Three things need to line up to enables better presbyopia correcting solutions for patients

Surgeons Ability

Clinical Performance Economics of Technology Surgeons Ability: Next generation tools will enable new intraocular $ approaches, leading to better outcome and efficiency

Motivation

Technical Training & Education Next Generation: • Pre-op diagnostics & planning Enabling Tools • Intra-op diagnostics • Post-op diagnostics

Practice Set-up & Management

Commercial Ability Technology: Many correlate time of introduction with performance... $

Multifocal IOLs EDFs Trifocal Accommodating

Clinical Performance

Currently approved in US Not approved in US Technology: I see things somewhat differently... $

1st gen EDFs Accommodating ??

Multifocal IOLs Trifocal

2nd gen. EDFs

Clinical Performance

Currently approved in US Not approved in US Technology: Expect different performances within each technology $ and expect overall different benefits across technologies

2nd gen. EDF Technologies Trifocal Technologies Accommodating Technologies

• Different optical principles • Key differences in optical • Multiple approaches under • Broad performance range technologies and IOL development (some come close to platforms across • Trifocal technology sets a Trifocal technology, others manufacturers impacting high bar to beat patient benefits not) • Will come sooner than later • Targeted application • Strong performances across key attributes, esp. defocus range and near VA

Currently approved in US Not approved in US THANK YOU Transforming the Future of IOLs October 2018 Broad View – IOL Market

High growth market - $3.9 B to emmetropia, astigmatism, presbyopia and $6.1 B - 2018-23 (12.8% CAGR) high quality optics • Demographics • Emerging Economies predictable outcomes, efficient surgeries, Emergence of “premium” market – minimal follow-up $1.16 B to $2.80 B (8.3% CAGR)

more premium products, IP protection, Premium market drives profitability for product platforms that address all segments the industry of premium markets

LENSGEN IS UNIQUELY POSITIONED TO MEET ALL THESE NEEDS…

Source: Market Scope

CONFIDENTIAL 35 A Complete IOL

ATTRIBUTE SURGEON & PATIENT EXPECTATIONS Presbyopia Corrected Dynamic, continuous – 2.0 D or more Contrast Sensitivity Monofocal quality Optical Quality Less halos and glare

Closer to Emmetropia Stable refractions Minimal Induced Astigmatism Small incision – suture less

Astigmatism Corrected Excellent rotational stability

Enhanced Cataract Negligible PCO Upgradable Modular design for upgrade or exchange

CONFIDENTIAL 36 Premium IOL – Competitive Matrix

MONOFOCAL MF EDoF FOCUS FEATURE MF ADJUST TORIC TORIC TORIC

Stable Enhanced Negligible PCO Cataract Unmet Market Less Glare/Halo

Exchangeable/Upgradeable Needs Emmetropia Adjustable

Presbyopia & Astigmatism

Presbyopia Dynamic Focus

Presbyopia

Astigmatism Toric

PATIENT NEEDS CURRENT TECHNOLOGIES

CONFIDENTIAL 37 LensGen Technology

CONFIDENTIAL 38 Juvene™ – How it Works

CONFIDENTIAL 39 Juvene – Dynamic and Continuous Focus

DISTANCE INTERMEDIATE AND NEAR

CONFIDENTIAL 40 PRESBYOPIA Defocus Curves

-0.1 20/20 0 Equivalent 20/25 0.1 20/32 0.2 20/40 0.3 3 lines improvement 0.4 0.5 0.6 0.7 0.8 0.9 66 cm 40 cm 1 1.1 N = 10 3 2 1 0 -1 -2 -3 -4 -5 -6 Monofocal LG EDoF

Juvene significantly outperforms leading EDoF at near Juvene same as leading EDoF at intermediate and distance

CONFIDENTIAL 41 PRESBYOPIA Stable Intermediate and Near Vision

0.50

20/50 0.40

20/40 0.30

20/30 0.20

20/20 0.10

0.00 Month 1 Month 2 Month 3 Month 6

-0.10 DCIVA DCNVA N=10 Eyes

CONFIDENTIAL 42 Standard IOL Compromises

COMPROMISES

• ELP Shift • Rotation • PCO • Vitreo-retinal Tension

CONFIDENTIAL 43 EMMETROPIA Juvene – Biomimetic Capsule Filling

PATIENT BENEFITS

• Stable ELP • Stable Refraction • Minimal IOL Rotation • Negligible PCO • Less Vitreo-retinal Tension

CONFIDENTIAL 44 EMMETROPIA Stable ELP

4.6

4.4

4.2

3.8

3.6 Anterior Chamber depth (mm) 3.4

3.2 Week 1 Week 2 Month 1 Month 2 Month 3

CONFIDENTIAL 45 ASTIGMATISM Rotational Stability

1 MONTH 33 MONTHS

TAB TAB

CONFIDENTIAL 46 ENHANCED CATARACT Pristine Capsules – No PCO

33 MONTHS 22 MONTHS 9 MONTHS 6 MONTHS

CONFIDENTIAL 47 Premium IOL – Competitive Matrix

MONOFOCAL MF EDoF JUVENE FOCUS FEATURE MF ADJUST TORIC TORIC TORIC TORIC

Stable Enhanced Less PCO Cataract Unmet Market Less Glare Exchangeable & Needs Upgradeable Emmetropia Adjustable

Astigmatism & Presbyopia

Presbyopia Dynamic Focus

Presbyopia

Astigmatism Monofocal, Toric, IOL

PATIENT NEEDS CURRENT TECHNOLOGIES

CONFIDENTIAL 48 Thank You BREAKOUT SESSION: INNOVATIVE INTRAOCULAR APPROACHES TO ADDRESS PRESBYOPIA

YARI STEVEN MODERATED BY: MITCHELL SMATHERS ACUFOCUS PERFECT LENS

ELIZABETH YEU, MD VIRGINIA EYE CONSULTANTS/EASTERN RAMGOPAL MAX VIRGINIA MEDICAL SCHOOL RAO WOLF, MID LENSGEN ALCON