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Corporate Presentation January 2018 Forward-Looking Statements - PowerPoint PPT Presentation

Corporate Presentation January 2018 Forward-Looking Statements This presentation has been prepared for informational purposes only and does not purport to be all-inclusive. We have based all forward-looking statements on our current


  1. Corporate Presentation January 2018

  2. Forward-Looking Statements This presentation has been prepared for informational purposes only and does not purport to be all-inclusive. We have based all forward-looking statements on our current expectations and projections about future 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 assurance that such results will be realized and actual results in each case could differ materially from those currently anticipated in such statements as a result of various factors. BioLight is not under any obligation to update or correct any future forecasts and/or forecasting statements to reflect events or circumstances after the date of this presentation. BioLight makes no express or implied representation or warranty as to the achievement of the forecasts or the accuracy or completeness of the information contained herein. BioLight expressly disclaims any and all liability which may be based on such information, errors therein or omissions therefrom. This presentation does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or sell securities of BioLight. 2

  3. Overview 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 • 3

  4. 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 • Strategic Investors Strategic Investors Dilip Shanghvi , founder and managing director of Sun Pharma, • Public (33%) India’s largest pharmaceutical company by market cap Strategic Dan Oren , founder, President & CEO of Dexcel Pharma, the 2nd Investors (57%) • largest pharmaceutical manufacturer in Israel Institutional (10%) Rock One , Hong Kong based company specialized in the • biomed and high-tech industries 4

  5. Targeting Three Major Ophthalmic Conditions Collection of ocular disorders characterized by progressive loss of visual • Glaucoma Glaucoma field due to optic nerve damage Over 80 million Over 80 million Usually involves uncontrolled increase in Inter Ocular Pressure (IOP) patients patients • worldwide worldwide Can lead to progressive, irreversible vision loss and blindness • ( ~7.3 million in U.S.) ( ~7.3 million in U.S.) Chronic disease that requires ongoing, lifelong treatment • Dry Eye Dry Eye Multi-factorial disorder of the ocular surface • Syndrome Syndrome Eye produces insufficient tears or tears with abnormal composition 350 million 350 million • patients patients Results in discomfort and visual disturbance • worldwide worldwide In most severe forms, can lead to permanent vision loss • (50 million in U.S.) (50 million in U.S.) AMD AMD Chronic, degenerative eye disease that affects the macula, the central • 30 – 50 million 30 – 50 million part of the retina, at the back of the eye patients patients Leading cause of permanent vision loss and irreversible blindness • worldwide worldwide among people aged 60 and older (15 million in U.S.) (15 million in U.S.) 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 5 without Even Knowing It; Improving the screening, diagnosis, and treatment of Dry Eye Disease: Expert Recommendations From The 2014 Dry Eye Summit

  6. Addressing Several Significant Unmet Medical Needs Glaucoma Glaucoma Eye-D Eye-D • Low compliance with prescribed administration of eye drops • Low compliance with prescribed administration of eye drops • Safer and more precise alternative to the complex and risky • Safer and more precise alternative to the complex and risky surgeries surgeries • Reduce burden of treatment • Reduce burden of treatment IOPtiMate TM IOPtiMate TM TeaRx TM TeaRx TM High need for objective, accurate and easy to use diagnostic tools High need for objective, accurate and easy to use diagnostic tools • • Dry Eye Dry Eye Strong demand for personalized treatment and companion Strong demand for personalized treatment and companion • • diagnostics solutions diagnostics solutions High need for new drugs with better tolerability, efficacy with High need for new drugs with better tolerability, efficacy with • • LIPITEAR TM LIPITEAR TM lower ocular and systemic side effects lower ocular and systemic side effects AMD AMD Reduce burden of treatment Reduce burden of treatment • • OphRx LLC OphRx LLC Greater efficacy & safety of medication Greater efficacy & safety of medication • • 6

  7. Our Strategy Our goal is to become a leading ophthalmic company by: Establishing a sales force to maximize the commercial Pursuing strategic Targeting large and potential of our partnership Developing and growing patient products opportunities expanding a balanced populations with and diverse pipeline of significant unmet ophthalmic products Maintaining a global needs and product diverse network of candidates ophthalmic specialists to accelerate knowledge synergies and innovation 7

  8. Eye-D 8

  9. Compliance is Key for Treatment Efficacy Approximately 50% of glaucoma patients may be non-compliant with their drug therapy administration Source: Compliance and adherence in glaucoma management Alan Robin1 and Davinder S Grover 9

  10. Eye-D: Product Positioning No need for Easy and safe Effective for daily eye in-office 3-6 months drops procedure Glaucoma standard Simple design, of care medication, solid IP preservative free 10

  11. 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 11

  12. 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 • 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 • Day 1 Day 4 Day 84 12

  13. Clinical Results Demonstrate Safety & Efficacy Supporting Supporting Safety Safety Efficacy Efficacy Information Information No severe adverse Evidence for Procedure • • • events were reported efficacious/preferred standardization: No conjunctival dose Location • • scarring, no infections Depth • >90% of the related Suture • • adverse events were Inserter • mild and transient Etc… • 13

  14. Eye-D VS-101 Market Opportunity Global glaucoma pharmaceutical market is expected to increase from Nearly 75% of the patients approximately $4.7 billion in indicate willingness to 2015 to nearly $6.1 billion in undergo a subconjunctival 2020 injection, while over 85% of patients willing to accept higher costs than eye drops 10-25% of newly prescribed for such treatments patients don’t refill their 2nd prescription. ~40-60% of newly prescribed patients are still taking their meds at end of year 1 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; 14 Glaucoma Research Foundation; Market Scope

  15. IOPtiMate ™ 15

  16. Laser is a Magic Word in Ophthalmology Refractive Cataract Glaucoma 2015 - IOPtiMate TM 1983 - Excimer 2009 - Laser Capsulotomy 16

  17. The IOPtiMate TM System: Transforming Glaucoma Surgery IOPtiMate TM system can Novel surgical system The procedure is that enables a non- be combined with any automated, easy to penetrating, CO2 laser- ophthalmic microscope perform providing a assisted procedure and CLASS is safer and more precise known as CLASS (CO2 performed as an alternative to the Laser-Assisted outpatient procedure, complex and risky Sclerotomy Surgery) to requiring only local glaucoma surgeries reduce elevated IOP anesthesia 17

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