Dry Eye Breakout Session

ModeraterEdward Holland, MD, Director, Cornea Service - Cincinnati Eye Institute/ Professor of Clinical Ophthalmology - University of Cincinnati

Panel Kim Brazzell, MD, PhD, Chief Medical Officer - Kala Pharmaceuticals

Preeya Gupta, MD, Associate Professor, Ophthalmology - Duke Eye Center

Patrick Mooney, VP & Head, Ophthalmology Franchise – Novartis

Elizabeth Yeu, MD, Partner - Virginia Eye Consultants / Assistant Professor, Ophthalmology - Eastern Virginia Medical School

Dry Eye Disease Market Overview

.

Financial Disclosures

• Aerie• Allegra• Alcon Laboratories, Inc.• Azura• BlephEx• BrimBiotech• CorneaGen• Dompe• EyePoint• Inversa• Johnson and Johnson• Kala Pharmaceuticals• Mati Pharmaceuticals• Merk KGgA• Novartis• Omeros• Ocuphire• Oyster Point• PreciseBio• ReTear• Senju • SightScience• SilkTech• Stuart• Takeda• TearLab• TopiVert• Vomaris• Zeiss

344 MILLION

WORLDWIDE

15-20MILLION

IN THE US

Market Scope estimates, Market Scope Dry Eye Report, 2016

Up to 30 -40 Million Undiagnosed in the US

INCREASINGLYPREVALENT RISK FACTORS

CONTACT LENS USE• 1 in 6 US adults wears contact lenses.1

• 73% of contact lens users report dissatisfaction or discontinuation due to symptoms.2

MULTISCREEN LIFESTYLE• 6 in 10 adults spend 5 or more hours/day on digital

devices3

• 1 in 4 kids spend 3 hours/day using digital devices3

• 92% of ECPs suspect modern technology contributes to dry eye symptoms4

OCULAR SURGERY• 48% of post-LASIK patients reported dryness for 6

months5

• Increased risk in post- cataract patients

1. Cope JR et al. Centers for Disease Control and Prevention. 2015;64(32):865-870. 2. Richdale K et al. Cornea. 2007;26(2):168-174. 3. Vision Council. 2015 Digital Eye Strain Report. 4. Shire National Eye C.A.R.E. Survey. 2016. 5. Market Scope estimates, Market Scope Dry Eye Report, 2016.

DOMINANT RISK FACTOR:

GROWTH OF AT-

RISK

POPULATION

The major factor determining

increase in dry eye prevalence over

the next 20 years is the size of

population at risk for dry eye.1

10,000 baby boomers will turn 65 years old every day until 2030.2

By 2050, 21% of the overall population will be over 65.2

1. Dry Eye Epidemiology. Decision Resources Group. December 2015. 2. Pew Research Center. Baby Boomers Retire. Dec 29, 2010. Available at: http://www.pewresearch.org/fact-tank/2010/12/29/baby-boomers-retire/. Accessed on April 4, 2017.

13.6 MILLION TREATED WITH ARTIFICIAL

TEARS OR Rx

6 MILLION REMAIN UNTREATED

Market Scope estimates, Market Scope Dry Eye Report, 2016

IN THE US...

GLOBAL DRY EYE POPULATION: TREATED vsUNTREADED

0

20

40

60

80

US WesternEurope

Japan OWN China India LatinAmerica

MIL

LIO

NS A

FFEC

TED

BY D

RY E

YE

Treated Untreated OWN = Other Wealthy Nations

Market Scope estimates, Market Scope Dry Eye Report, 2016.

F

16.4%11.5%

7.7%

3.0%

0.7%

0.7%1.5%

58.6%

Global Dry Eye Market Revenues

United States

Western Europe

Japan

OWN

China

Latin America

India

ROW

0%

5%

10%

15%

20%

25%

United States

Weste

rn Euro

peJapan

OWN

ChinaIndia

Latin

America

ROWGlobal

3.1%

8.1%

2.8%

6.1%

21.4%

25.1%

15.3%

19.1%

5.5%

Forecast for Compounded Growth in the Global Dry Eye Market

OWN = Other Wealthy Nations

ROW = Rest of World

DRY EYE - HEALTHY MARKET US AND GLOBAL MARKET POSITIONED FOR GROWTH

Market Scope estimates, Market Scope Dry Eye Report. R

eve

nu

e C

AG

R:

20

16

-20

21

DRY EYE Landscape 201714 PRODUCTS IN CLINICAL DEVELOPMENT

TrueTear

Klarity

Discovery

2017

Lau

nche

s

Phas

e 3

Phas

e1/

2

CyclASol

Restasis X

P-321

ISV-101

Lubricin; VAY736

Dextenza

Seciera

KPI-121

RGN-259

MIM-D3

SkQ1

Dry eye landscape 2019

Pre-clinical Phase 1 Phase 2 Phase 3 Pre-Reg Approved

Infla

mm

ator

yNo

n-in

flam

mat

ory

KPI-121

Cequa

CyclASol

T-1580

OCU-310

TOP1630

PADcicloVoclosporin

ADX-102

HL036

OC-01, OC-02

rhDNase

Elate Ocular

NM133

SDP-4Nov-07

SURF-100

Restasis

HU-007

Ikervis, Diquas Klarity-C

Softacort / Softacor1

CsA- MiDROPS

PP-001

KPI-190

Pro-OcularSA001, SJP002

HU-024

ZK-014

NOV033

OKYO-0101

Xiidra

1Softacort is only approved for the treatment of mild non-infectious allergic or inflammatory conjunctival diseases; however, a Phase 4 trial has recently been initiated investigating efficacy in patients with chronic DED and ocular surface inflammation

Tear Lab Discovery

Diagnostic device

2The lead indication for Oxervate is neurotrophic keratitis (NK) and this is the only indication for which the asset has received regulatory approval in Europe and the US3Approved in the EU as the OTC product EvoTears

Ocular NaV1.7

Unnamedprogram

OCU-001

SI-01

BRM-421

Oxervate2

AVX-012

TAK759

ECF-843

Lacripep

OCS-02

RP101

Visomitin

RGN-259

SYL-1001

SJP-0035

YY-101

Palovarotene

VVN001

Treatment Strategies for Meibomian Gland Dise

ase

Conclusion

§ Dry eye disease is a very common disorder that is often ignored and underdiagnosed by clinicians

§ Dry eye disease can have a significant impact on:• Patients’ vision, comfort, and

quality of life• Your surgical outcomes

§ Dry eye disease is progressive § New technologies will improve

the clinicians’ ability to properly and efficiently diagnose dry eye

§ New treatments will provide more effective options for treatment of dry eye disease