Corporate Presentation April 2018 - BioLight...higher costs than eye drops for such treatments Eye-D...

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Corporate Presentation April 2018

Transcript of Corporate Presentation April 2018 - BioLight...higher costs than eye drops for such treatments Eye-D...

Page 1: Corporate Presentation April 2018 - BioLight...higher costs than eye drops for such treatments Eye-D VS-101 Market Opportunity Source: Market Scope: Charting the course of the eye

Corporate PresentationApril 2018

Page 2: Corporate Presentation April 2018 - BioLight...higher costs than eye drops for such treatments Eye-D VS-101 Market Opportunity Source: Market Scope: Charting the course of the eye

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Forward-Looking Statements

This presentation has been prepared for informational purposes only and does not purport to beall-inclusive.

We have based all forward-looking statements on our current expectations and projections aboutfuture events. These forward-looking statements are subject to known and unknown risks,uncertainties and assumptions about us and our affiliate companies. There can be no assurancethat such results will be realized and actual results in each case could differ materially from thosecurrently anticipated in such statements as a result of various factors. BioLight is not under anyobligation to update or correct any future forecasts and/or forecasting statements to reflectevents or circumstances after the date of this presentation.

BioLight makes no express or implied representation or warranty as to the achievement of theforecasts or the accuracy or completeness of the information contained herein. BioLight expresslydisclaims any and all liability which may be based on such information, errors therein or omissionstherefrom.

This presentation does not constitute an offer to sell or the solicitationof an offer to subscribe for or buy or sell securities of BioLight.

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• Focused on discovery, development and commercialization of products which target ophthalmic conditions including:

• Glaucoma

• Dry eye syndrome (DES)

• Age-related macular degeneration (AMD)

• Products are designed to address a number of significant unmet medical needs by:

• Reducing burden of treatment

• Improving compliance, efficacy and safety of treatment

• Offering better diagnosis and personalize treatment

• Optimizing delivery of medications

Overview

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Corporate Information

• Traded on Tel Aviv Stock Exchange (BOLT)

• 3.6 million shares outstanding

• Backed by strategic investors with significant life sciences experience

• Israel Makov, former President & CEO of Teva Pharma

• Dilip Shanghvi, founder and managing director of Sun Pharma,

India’s largest pharmaceutical company by market cap

• Dan Oren, founder, President & CEO of Dexcel Pharma, the 2nd

largest pharmaceutical manufacturer in Israel

• Rock One, Hong Kong based company specialized in the

biomed and high-tech industries

Str

ate

gic

In

vest

ors

Public (33%)

Institutional(10%)

Strategic Investors (57%)

Page 5: Corporate Presentation April 2018 - BioLight...higher costs than eye drops for such treatments Eye-D VS-101 Market Opportunity Source: Market Scope: Charting the course of the eye

• Collection of ocular disorders characterized by progressive loss of visual field due to optic nerve damage

• Usually involves uncontrolled increase in Inter Ocular Pressure (IOP)

• Can lead to progressive, irreversible vision loss and blindness

• Chronic disease that requires ongoing, lifelong treatment

• Multi-factorial disorder of the ocular surface

• Eye produces insufficient tears or tears with abnormal composition

• Results in discomfort and visual disturbance

• In most severe forms, can lead to permanent vision loss

• Chronic, degenerative eye disease that affects the macula, the central part of the retina, at the back of the eye

• Leading cause of permanent vision loss and irreversible blindness among people aged 60 and older

Targeting Three Major Ophthalmic Conditions

GlaucomaOver 80 million

patients worldwide

(~7.3 million in U.S.)

Dry Eye Syndrome350 million

patients worldwide

(50 million in U.S.)

AMD30 – 50 million

patients worldwide

(15 million in U.S.)

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Source: Market Scope: 2015 Report on the Global Glaucoma Surgical Device Market; AMD.org: AMD Partnership Features Age Related Macular Degeneration Info; MasterEyeAssociates: Definition of Dry Eye Disease; F1000 Prime Reports: Advances in the management of macular degeneration; American Society of Retina Specialists: Millions of Americans Have Age-Related Macular Degeneration (AMD) – Many without Even Knowing It; Improving the screening, diagnosis, and treatment of Dry Eye Disease: Expert Recommendations From The 2014 Dry Eye Summit

Page 6: Corporate Presentation April 2018 - BioLight...higher costs than eye drops for such treatments Eye-D VS-101 Market Opportunity Source: Market Scope: Charting the course of the eye

• High need for objective, accurate and easy to use diagnostic tools• Strong demand for personalized treatment and companion

diagnostics solutions• High need for new drugs with better tolerability, efficacy with

lower ocular and systemic side effects

• Low compliance with prescribed administration of eye drops

• Safer and more precise alternative to the complex and risky surgeries

• Reduce burden of treatment

Eye-D

IOPtiMateTM

TeaRxTM

Gla

uco

ma

Dry

Eye

OphRx LLC• Reduce burden of treatment

• Greater efficacy & safety of medicationAM

DAddressing Several Significant Unmet Medical Needs

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LIPITEARTM

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Our goal is to become a leading ophthalmic company by:

Our Strategy

Developing and expanding a balanced and diverse pipeline of ophthalmic products

and product candidates

Targeting large and

growing patient

populations with

significant unmet

needsMaintaining a global diverse network of

ophthalmic specialists to accelerate

knowledge synergies and innovation

Pursuing strategic

partnership

opportunities

Establishing a sales

force to maximize

the commercial

potential of our

products

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Eye-D

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Approximately 50% of glaucoma

patients may be non-compliant

with their drug therapy

administration

Compliance is Key for Treatment Efficacy

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Eye-D : Product Positioning

No need for daily eye

drops

Effective for

3-6 months

Easy and safe in-office

procedure

Glaucoma standard

of care medication,

preservative free

Simple design,

solid IP

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Our Solution: Eye-D

• Platform technology that enables a controlled release of ophthalmic medications over time through a subconjunctival insert

• First product candidate (VS-101), contains latanoprost, the most prescribed glaucoma medication worldwide

• VS-101 Phase 1/2a clinical study in the U.S. as part of 505(b)(2) regulatory pathway was completed in July 2017

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Clinical Results Demonstrate Safety & Efficacy

Phase 1/2a protocol:

• Randomized, blinded, controlled

• Compared three different insert elution rates (high, medium & low) with latanoprost eye drops (control group)

• 39 subjects, 3 months duration

Day 1 Day 4 Day 84

Demonstrated:• Proof of concept in humans achieved• Safety endpoint achieved (no unanticipated findings, no severe adverse events)• Evidence for efficacious/preferred dose (high dose)• Supporting information for improving retention in phase 2b

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Clinical Results Demonstrate Safety & Efficacy

Safety Efficacy Supporting Information

• No severe adverse events were reported

• No conjunctival scarring, no infections

• >90% of the related adverse events were mild and transient

• Evidence for efficacious/preferred dose

• Procedure standardization:• Location• Depth• Suture• Inserter• Etc…

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Global glaucoma pharmaceutical market is expected to increase from approximately $4.7 billion in 2015 to nearly $6.1 billion in 2020

10-25% of newly prescribed

patients don’t refill their 2nd

prescription ~40-60% of

newly prescribed patients

are still taking their meds at

end of year 1

Nearly 75% of the patients indicate willingness to undergo a subconjunctival injection, while over 85% of patients willing to accept higher costs than eye drops for such treatments

Eye-D VS-101 Market Opportunity

Source: Market Scope: Charting the course of the eye care market.; Glaucoma Now – Issue No 2, 2013 Clinical Issues: Patient acceptance of ocular implants for Glaucoma Drug Delivery.Quigley HA Glaucoma: What Every Patient Should Know 2011; Friedman DS et al Invest Ophthalmol Vis Sci. 2007; Glaucoma Research Foundation; Market Scope

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IOPtiMate™

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Laser is a Magic Word in Ophthalmology

Refractive1983 - Excimer

Glaucoma2015 - IOPtiMateTM

Cataract2009 - Laser Capsulotomy

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Novel surgical system that enables a non-

penetrating, CO2 laser-assisted procedure

known as CLASS (CO2 Laser-Assisted

Sclerotomy Surgery) to reduce elevated IOP

The procedure is

automated, easy to

perform providing a

safer and more precise

alternative to the

complex and risky

glaucoma surgeries

IOPtiMateTM system can be combined with any

ophthalmic microscope and CLASS is

performed as an outpatient procedure,

requiring only local anesthesia

The IOPtiMateTM System: Transforming Glaucoma Surgery

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Worldwide Clinical Results Demonstrate High Efficacy & Safety

Source: Am J Ophthalmol. 2009 Nov;148(5):670-84; 2009 Aug 11; Three-year follow-up of the tube versus trabeculectomy study; Gedde SJ, American Journal of Ophthalmology (2007) Volume: 143, Issue: 1, Pages: 23-31; Surgical complications In the Tube Versus Trabeculectomy Study during the first year of follow-up; Steven J Gedde 7

Clinical Trials Overview:

Data from multi-center clinical study performed on 111 patients in 9 sites with 5-years follow up demonstrate:• Significant long term IOP reduction, stable over time• Extremely low post operative complication rate• Long term reduction in medication

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Worldwide Clinical Results Demonstrate High Efficacy & Safety

Performed on 111 patients in 9 sites with 5-years follow up

Source: Am J Ophthalmol. 2009 Nov;148(5):670-84; 2009 Aug 11; Three-year follow-up of the tube versus trabeculectomy study; Gedde SJ, American Journal of Ophthalmology (2007) Volume: 143, Issue: 1, Pages: 23-31; Surgical complications In the Tube Versus Trabeculectomy Study during the first year of follow-up; Steven J Gedde 7

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Binding Agreement of Investment in and Acquisition of IOPtima

In November 2017, we have entered into a binding agreement for the investment in and the

acquisition in stages of IOPtima by the Chengdu Kanghong Pharmaceutical Group Co:

First stage (completed at March 2018)

$7M investment into IOPtima

(pre-money valuation of $30M)

Second stage (H2/2018) –

acquiring 40% shares from

shareholders (valuation of $42M)

Third stage (Q2/2019) - acquiring

20% shares from shareholders

(valuation of $40-$56MM)

Forth stage (Q2/2021) - acquiring

20% shares from shareholders

(valuation of $40-$56MM)

If the second stage will be completed as planned, BioLight and its Board of Directors will positively

consider a dividend distribution to BioLight Shareholders.

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Designed to enable a wider range of

ophthalmic surgeons to perform glaucoma

surgeries

Has the potential to replace existing

glaucoma medical procedures driving an

increase in the quantity and quality of

glaucoma surgeries worldwide

Currently being marketed primarily in

Asia (mainly China, the world’s leading

country with glaucoma diagnosed patients), Europe, Canada and

Latin America

Over 4,000 CLASS procedures already

conducted worldwide to-date

IOPtiMateTM System Market Opportunity

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TeaRx™

Page 23: Corporate Presentation April 2018 - BioLight...higher costs than eye drops for such treatments Eye-D VS-101 Market Opportunity Source: Market Scope: Charting the course of the eye

Dry Eye Syndrome – Significant Unmet Needs

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350 million people worldwide suffer from Dry Eye Syndrome (DES)

There is a need for objective, actionable information that physicians can use to understand the root cause of patients complaints, enable personalized treatment, determine the effectiveness of the selected therapy and enable effective follow-up

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TeaRxTM : Transforming Dry Eye Disease Management

TeaRxTM

uses proprietary technology to deliver fast, semi-quantitative, personalized insights

to the causes of dry eye:

Collecting and diluting

A multichannel cassette- testing

several biomarkers simultaneously

Scoring based on intensity scale card

or electronic reader

Friendly output of multivariate

algorithm

Page 25: Corporate Presentation April 2018 - BioLight...higher costs than eye drops for such treatments Eye-D VS-101 Market Opportunity Source: Market Scope: Charting the course of the eye

Companion DiagnosticsSpecifically tailored biomarker assay development in order to

identify responders population for specific MOA

Point of CareA rapid, simple, office based, semi-quantitative analysis of the

tear film

Clinical trials• Strong correlation with benchmark tests (n=200) • 86% sensitivity and 87% specificity in identifying DES (n=74) • Final results from an additional clinical trial (n=82)

reconfirmed planned timeline for CE approval and FDA pivotal trial

Next steps• CE approval H2/2018• FDA pivotal trial –initiation H2/2018, approval H2/2019• Developing TearRx next generation, an electronic reader;

additional biomarkers providing more information to physician

Collaboration• Inserting our companion diagnostics tool into ph3 clinical

trial for a DES drug• Collaborating with a medical device company

Next steps• Partnering with additional companies to develop specific

algorithms and testing them in the context of clinical trials

TeaRxTM : Noval Platform, Multiple Applications

The TeaRxTM

is a novel platform for diagnosing and monitoring Dry Eye Syndrome (DES)

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Page 26: Corporate Presentation April 2018 - BioLight...higher costs than eye drops for such treatments Eye-D VS-101 Market Opportunity Source: Market Scope: Charting the course of the eye

TeaRxTM: Positive Clinical Trials Results

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• In a 200 DES patients study, the TeaRx demonstrated strong correlation with the

widely used benchmark tests (Schirmer, BUT, Staining, Questionnaire)

• In a 74 patients study, the TeaRx showed a 86% sensitivity and 87% specificity in

distinguishing between DES patients and healthy subjects

• A recent study enrolled 82 subjects (41 healthy, 41 with DES) reconfirmed planned

timeline in H2/2018 for CE approval and FDA pivotal trial

Page 27: Corporate Presentation April 2018 - BioLight...higher costs than eye drops for such treatments Eye-D VS-101 Market Opportunity Source: Market Scope: Charting the course of the eye

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TeaRxTM Market Opportunity

Source: MasterEyeAssociates: Definition of Dry Eye Disease; Improving the screening, diagnosis, and treatment of Dry Eye Disease: Expert Recommendations From The 2014 Dry Eye Summit; The economic burden of dry eye disease in the United States: a decision tree analysis.

Existing tests diagnose signs & symptoms and measure

only single tear component

Only 2 drug currently has FDA approval,

Restasis, Allergan and Xiidra, Shire. Approx. 12

new drugs in Phase II/Phase III stage

Strong demand for personalized treatment

and companion diagnostics solutions

350 million people are effected by Dry Eye Syndrome

(DES) worldwide, of whom 50 million are in the U.S.

Diagnostics Treatment

One of the leading causes of patients’ visits to eye care

practitioners in the U.S.

No gold standard solution

Many therapeutics fail in Phase 3 due to

• Patients selection

• End points definitions

Overall estimated annual burden for the U.S. health-care

system of approximately $4 billion

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LIPITEAR™

Page 29: Corporate Presentation April 2018 - BioLight...higher costs than eye drops for such treatments Eye-D VS-101 Market Opportunity Source: Market Scope: Charting the course of the eye

LIPITEARTM : Product Description and Advantages

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• LIPITEAR™ - microemulsion consists of phospholipidis and triglycerides which forms a tear film-like elastic

lipid shield, a class III medical device, certified with a CE.

• LIPITEAR™ is indicated for use for ocular surgery post-operative (e.g. refractive surgery, cataract surgery

and corneal transplant), corneal erosions and Dry eye Syndrome

• LIPITEAR™ is the only product in the eye drop market with a clinically proven indication of enhancement

of corneal re-epithelization following mechanical, traumatic and surgical epithelial loss

• While other treatments for dry eye are mainly water-based artificial

tears supplemented with variety of viscose substances, LIPITEAR™

offers a formula which is the closest to the natural tear film and can

restore both the aqua layer and the protective lipid layer of the tear

film. This quality results in a prolonged relieving effect of severe dry

eye symptoms

Page 30: Corporate Presentation April 2018 - BioLight...higher costs than eye drops for such treatments Eye-D VS-101 Market Opportunity Source: Market Scope: Charting the course of the eye

The LIPITEARTM Platform Technology

• The LIPITEARTM is a micro-emulsion technology which consist of a combination of

phospholipids and triglycerides.

• Phospholipids advantages:

• Stabilize the tear film

• Maintain the tear film lipid structure organized in an orderly and elastic manner

• Triglycerides advantages:

• Reconstitute the physiological lipid shield, which controls the evaporation of tear film and

its optical properties

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Page 31: Corporate Presentation April 2018 - BioLight...higher costs than eye drops for such treatments Eye-D VS-101 Market Opportunity Source: Market Scope: Charting the course of the eye

The LIPITEARTM Plus: Platform Technology

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Being a micro-emulsion vehicle, the technology can be

used as a drug delivery platform

Its unique pharmaceutical advantages include:

• Longer contact time between the drug and the eye surface,

increasing compliance

• Dual treatment - dry eye treatment + treatment of other ocular

diseases using one eye drop

• Potential slow release capabilities with lipid solubility drugs

Leveraging platform technology capabilities to:

• Formulate advanced pharmaceutical preparations of

new as well as for known drugs

• Formation of an elastic lipid shield above the cornea

• Incorporation of lipophilic drug molecules

• Combination of hydrophilic and lipophilic molecules in one

preparation

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LIPITEARTM Plus: Pipeline Opportunity

Indication OTC/Rx Status

LPC-001LIPITEAR + nutrition supplement

Dry eye OTCPost Pre-Clinical

LPC-002LIPITEAR + new anti oxidant mechanism

Dry eye and anti-aging processes

OTC/RxPre-Clinical

LPC-003LIPITEAR new indication

Eye Protection OTCPost Pre-Clinical

LPC-004LIPITEAR + glaucoma API

Dry eye + Glaucoma

RxPre-Clinical

LPC-005LIPITEAR + New dose API

Ocular inflammation

RxPre-Clinical

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OphRx LLC

Page 34: Corporate Presentation April 2018 - BioLight...higher costs than eye drops for such treatments Eye-D VS-101 Market Opportunity Source: Market Scope: Charting the course of the eye

An alternative solution to current ocular drug delivery modalities

Topical drug delivery for both the front and the back of the eye

OphRx LLC Technology Platform

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Changing the Current Interavitreal Injections Administration To Eye Drops Administration

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• Technology designed for improved molecules’ transport across membranes

• Unique liquid crystals structures allow loading of different kind of molecules and their

release at different target areas

• Tailor-made formulations based on nano-sized, self-assembled liquid droplets and on

modified lyotropic liquid crystalline 2-3 dimensional structures loaded with API

molecules that are effectively released upon interaction with target tissues

• Indifferent to hydrophobic/hydrophilic constrains

• Results of preclinical studies showed that the delivery platform enables a safer more

efficient drug delivery for both the front and back of the eye

OphRx LLC Drug Delivery Technology Platform

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• Cost effective technology:

few months project for new molecule formulation

• High safety profile:

Leveraging commercially used APIs

All used particles and excipients are FDA-approved

• As easy to prepare as alka seltzer in a glass

• Dedicated IP per molecule

OphRx LLC Drug Delivery Technology Advantages

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Pipeline includes:

• Topical administration for back of the eye applications

• High potency front of the eye applications

Commercial value:

• Leveraging on commercial APIs

• Short route for new-molecules development

• Enhanced bioavailability

• Reduced side effects

• New claims based on bioavailability and new doses

• Potentially extending patent protection as a new delivery method

• Strong IP per molecule

OphRx LLC Pipeline and Commercial Value

Page 38: Corporate Presentation April 2018 - BioLight...higher costs than eye drops for such treatments Eye-D VS-101 Market Opportunity Source: Market Scope: Charting the course of the eye

AMD affects 30 to 50 million people worldwide, of whom 15 million are in the U.S.

Only 1 drug currently has FDA approval with limited efficacy and tolerability

DES affects 350 million people worldwide, of whom 50

million in the U.S.

600,000 new cases diagnosed globally each year, of which

over 200,000 are in the U.S

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A number of significant unmet needs in treating AMD, many of which stem from current need for frequent intravitrealinjections

OphRx LLC Market OpportunityD

ES

AM

D

Source: Market Scope: 2015 Report on the Global Glaucoma Surgical Device Market; AMD.org: AMD Partnership Features Age Related Macular Degeneration Info; MasterEyeAssociates: Definition of Dry Eye Disease; F1000 Prime Reports: Advances in the management of macular degeneration; American Society of Retina Specialists: Millions of Americans Have Age-Related Macular Degeneration (AMD) – Many without Even Knowing It; Improving the screening, diagnosis, and treatment of Dry Eye Disease: Expert Recommendations From The 2014 Dry Eye Summit

Page 39: Corporate Presentation April 2018 - BioLight...higher costs than eye drops for such treatments Eye-D VS-101 Market Opportunity Source: Market Scope: Charting the course of the eye

• Potential for becoming the standard of care demonstrating high correlation with existing tests and superb diagnosis capabilities

• Third U.S. clinical trial completed• Collaboration with Pharma company for companion diagnostics

• Phase 1/2a completed

• Safety achieved, evidence for efficacious dose

• Front of the eye indications in pre-clinical stage

• Back of the eye indications in formulation stage

BioLight : Portfolio Status

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• Thousands of successful commercial procedures

• Signed agreement with Kanghong, with first stage completed

• First commercial product marketed in Europe

• 5 new indications in pre-clinical phase

Eye-D

IOPtiMateTM

TeaRxTM

Gla

uco

ma

Dry

Eye

OphRx LLC

AM

D

LIPITEARTM

Page 40: Corporate Presentation April 2018 - BioLight...higher costs than eye drops for such treatments Eye-D VS-101 Market Opportunity Source: Market Scope: Charting the course of the eye

• CE H2/2018• FDA Pivotal trial initiation H2/2018, approval H2/2019• Global product launch H2/2019• Companion Dx collaborations 2018-19

• Preparations for Phase 2b

• Completion of pre-clinical studies

BioLight : Next Milestones

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• Collaboration with Kanghong, including completion of second stage in H2/2018 and third stage in Q2/2019

• Sales ramp up, launch in additional countries

• R&D process with 5 indications

Eye-D

IOPtiMateTM

TeaRxTM

Gla

uco

ma

Dry

Eye

OphRx LLC

AM

D

LIPITEARTM

Page 41: Corporate Presentation April 2018 - BioLight...higher costs than eye drops for such treatments Eye-D VS-101 Market Opportunity Source: Market Scope: Charting the course of the eye

Multiple Opportunities in High-Growth MarketsOur pipeline addresses a number of significant unmet medical needs of large and growing patient populations

Strong Leadership TeamNotable combination of world-renowned key shareholders and experienced management team as well as a network of ophthalmic specialists

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In Summary

Innovative Business ModelMulti-product pipeline in various commercialization and development stages that, if successful, are expected to result in multiple value inflection events, lead to collaborations with other third parties, reduce risk to our business associated with a particular product or product candidate and increase return on investment