EyeGate Pharmaceuticals has two drug delivery platforms for eye disorders - an ocular bandage gel (OBG) eye drop and an iontophoresis delivery system. The OBG eye drop is a crosslinked hyaluronic acid gel that accelerates wound healing in the cornea. It has completed clinical trials showing accelerated re-epithelialization of corneal wounds. The iontophoresis system delivers corticosteroids into the eye using a mild electrical current, reducing the need for eye drops. Its lead product EGP-437 is being studied for inflammation after cataract surgery and uveitis, with clinical trials demonstrating trends of better outcomes than placebo.
Anterior Segment Company Showcase - AcuFocusHealthegy
Anterior Segment Company Showcase - AcuFocus at OIS@AAO 2016.
Presenter:
Al Waterhouse, President
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
Anterior Segment Company Showcase - AcuFocusHealthegy
Anterior Segment Company Showcase - AcuFocus at OIS@AAO 2016.
Presenter:
Al Waterhouse, President
Powered by:
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For more ophthalmology innovation
Visit us at www.ois.net
For an Executive Summary of this report please contact ediz.ibrahim@visiongain.com (+44 (0)20 7549 9976) or refer to our website https://www.visiongain.com/Report/1272/Ophthalmic-Devices-Market-Forecast-2014-2024
Anterior Segment Company Showcase - Z lensHealthegy
Anterior Segment Company Showcase - Z lens at OIS@AAO 2016.
Presenter:
Paul Beer, MD, Founder & CEO
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
A full range of Eye Protectors, Sunglasses, Ballistic Eyewear and Prescribed Frames with Frame Materials and Lenses, EYREShas the Edge to Demonstrate the latest Technological Advances in Certified Optics
This Tutorial has been designed to assist the Candidate in preparing for ABO & NCLE’s Practical Examinations. There are additional helpful links and information at the end of the Tutorial. If you have questions, please contact the ABO & NCLE Office for assistance. *ABO & NCLE is accredited by the International Certification Accreditation Council (ICAC). ABO & NCLE is the only Opticianry examination organization in the United States to have received Accreditation as a Certifying Organization, pursuant to the International Organization for Standardization (ISO/IEC 17024). The forty-five minute practical assessment examinations are designed and developed by groups of Certified Opticians and Certified Contact Lens Fitters/Technicians with assistance from an independent testing service. The purpose of these Exams is to apply the knowledge previously demonstrated by the candidates to skills and abilities associated with the performance of tasks required for the professional practice of Opticianry and/or Contact Lens Technology.
HospitalSoftwareShop Eye hospital software is a ready to use, proven, fully integrated software solution widely adopted by leading ophthalmologists / eye specialists in India to manage patient records, billing, pharmacy, optical shops, accounts, and various other administrative activities. Software for eye hospitals is highly customized to meet specific needs for an Ophthalmology practice
PAYING FOR BREAKTHROUGH EYE THERAPIES (BIOLOGICS, BIOSIMILARS & GENE THERAPIE...Healthegy
Presentation by AGTC at OIS@ASRS 2016.
Participant:
Stephen Potter, Chief Business Officer - AGTC
Powered by:
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For more ophthalmology innovation
Visit us at www.ois.net
Posterior Segment Company Showcase - Ocular TherapeutixHealthegy
Posterior Segment Company Showcase - Ocular Therapeutix at OIS@AAO 2016.
Presenter:
Amar Sawhney, PhD, President, CEO & Chairman
Powered by:
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For more ophthalmology innovation
Visit us at www.ois.net
Presentation from OIS@ASCRS 2016
Co-Moderators:
Gilbert H. Kliman, MD, Managing Director – InterWest Partners
Stephen Slade, MD
Company Presentations
Equinox | John Berdahl, MD, Founder & CEO
Presbyopia Therapies | Jim McCollum, Co-Founder
Stroma Medical | Doug Daniels, CEO
Eyenovia | Curt LaBelle, MD, Director
Wicab | Robert Beckman, President & COO
For an Executive Summary of this report please contact ediz.ibrahim@visiongain.com (+44 (0)20 7549 9976) or refer to our website https://www.visiongain.com/Report/1272/Ophthalmic-Devices-Market-Forecast-2014-2024
Anterior Segment Company Showcase - Z lensHealthegy
Anterior Segment Company Showcase - Z lens at OIS@AAO 2016.
Presenter:
Paul Beer, MD, Founder & CEO
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
A full range of Eye Protectors, Sunglasses, Ballistic Eyewear and Prescribed Frames with Frame Materials and Lenses, EYREShas the Edge to Demonstrate the latest Technological Advances in Certified Optics
This Tutorial has been designed to assist the Candidate in preparing for ABO & NCLE’s Practical Examinations. There are additional helpful links and information at the end of the Tutorial. If you have questions, please contact the ABO & NCLE Office for assistance. *ABO & NCLE is accredited by the International Certification Accreditation Council (ICAC). ABO & NCLE is the only Opticianry examination organization in the United States to have received Accreditation as a Certifying Organization, pursuant to the International Organization for Standardization (ISO/IEC 17024). The forty-five minute practical assessment examinations are designed and developed by groups of Certified Opticians and Certified Contact Lens Fitters/Technicians with assistance from an independent testing service. The purpose of these Exams is to apply the knowledge previously demonstrated by the candidates to skills and abilities associated with the performance of tasks required for the professional practice of Opticianry and/or Contact Lens Technology.
HospitalSoftwareShop Eye hospital software is a ready to use, proven, fully integrated software solution widely adopted by leading ophthalmologists / eye specialists in India to manage patient records, billing, pharmacy, optical shops, accounts, and various other administrative activities. Software for eye hospitals is highly customized to meet specific needs for an Ophthalmology practice
PAYING FOR BREAKTHROUGH EYE THERAPIES (BIOLOGICS, BIOSIMILARS & GENE THERAPIE...Healthegy
Presentation by AGTC at OIS@ASRS 2016.
Participant:
Stephen Potter, Chief Business Officer - AGTC
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
Posterior Segment Company Showcase - Ocular TherapeutixHealthegy
Posterior Segment Company Showcase - Ocular Therapeutix at OIS@AAO 2016.
Presenter:
Amar Sawhney, PhD, President, CEO & Chairman
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
Presentation from OIS@ASCRS 2016
Co-Moderators:
Gilbert H. Kliman, MD, Managing Director – InterWest Partners
Stephen Slade, MD
Company Presentations
Equinox | John Berdahl, MD, Founder & CEO
Presbyopia Therapies | Jim McCollum, Co-Founder
Stroma Medical | Doug Daniels, CEO
Eyenovia | Curt LaBelle, MD, Director
Wicab | Robert Beckman, President & COO
Posterior Segment Company Showcase - AGTCHealthegy
Posterior Segment Company Showcase - AGTC at OIS@AAO 2016.
Presenter:
Sue Washer, President & CEO
Powered by:
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For more ophthalmology innovation
Visit us at www.ois.net
Presentation from OIS@ASCRS 2016
Amar Sawhney, PhD, President, CEO & Chairman
Video Presentation:
https://www.youtube.com/watch?v=nGQzo6czij0&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=31
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journey
EyeGate Pharma CEO Investor Presentation to BioCEO 2018
1. NASDAQ: EYEG
EyeGate Pharmaceuticals, Inc.
271 Waverley Oaks Road, Suite 108 Waltham, MA 02452
www.eyegatepharma.com
Two Versatile Platforms
Moving Towards
Commercialization
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2. Forward Looking Statements
Some of the matters discussed in this presentation contain forward-looking statements that involve significant risks and uncertainties, including statements
relating to the prospects for the Company’s lead product EGP-437, for the timing and outcome of the Company’s clinical trials, the potential approval to market
EGP-437, and the Company’s capital needs. Actual events could differ materially from those projected in this presentation and the Company cautions investors
not to rely on the forward-looking statements contained in, or made in connection with, the presentation.
Among other things, the Company’s clinical trials may be delayed or may eventually be unsuccessful. The Company may consume more cash than it currently
anticipates and faster than projected. Competitive products may reduce or eliminate the commercial opportunities of the Company’s product candidates. If the
U.S. Food and Drug Administration or foreign regulatory agencies determine that the Company’s product candidates do not meet safety or efficacy endpoints in
clinical evaluations, they will not receive regulatory approval and the Company will not be able to market them. Operating expense and cash flow projections
involve a high degree of uncertainty, including variances in future spending rate due to changes in corporate priorities, the timing and outcomes of clinical trials,
regulatory and developments and the impact on expenditures and available capital from licensing and strategic collaboration opportunities. If the Company is
unable to raise additional capital when required or on acceptable terms, it may have to significantly alter, delay, scale back or discontinue operations.
Additional risks and uncertainties relating to the Company and its business can be found in the “Risk Factors” section of the Company’s Annual Report on Form 10-
K filed with the SEC on February 23, 2017. The Company undertakes no duty or obligation to update any forward-looking statements contained in this
presentation as a result of new information, future events or changes in the Company’s expectations, except as required by applicable law.
The Company uses its website (www.EyeGatePharma.com), Facebook page (https://www.facebook.com/ EyeGatePharma/), corporate Twitter account
(https://twitter.com/EyeGatePharma), and LinkedIn page (https://www.linkedin.com/company/135892/) as channels of distribution of information about the
Company and its product candidates. Such information may be deemed material information, and the Company may use these channels to comply with its
disclosure obligations under Regulation FD. Therefore, investors should monitor the Company’s website and its social media accounts in addition to following its
press releases, SEC filings, public conference calls, and webcasts. The social media channels that the Company intends to use as a means of disclosing the
information described above may be updated from time to time as listed on the Company’s investor relations website.
2
3. Two platforms in the clinic with two FDA filings expected in 2018
3
Two Product Platforms for Eye Disorders
Ocular Bandage Gel (OBG) Eye Drop:
Disrupting Dry Eye and Corneal Wound Market
EyeGate II Iontophoresis Delivery System:
Delivering a Corticosteroid (EGP-437)
Disease Area Preclin POC Pilot Pivotal
Large Corneal Wounds
Photorefractive Keratectomy
Punctate Epitheliopathies
Focus: Moderate Dry Eye
Punctate Epitheliopathies
Focus: Severe Dry Eye
OBG + Corticosteroid
Disease Area Preclin Ph 1b/2a Ph 2b Ph 3
Anterior Uveitis
Cataract Surgery
Contact Lens
Macular Edema
4. Ocular Bandage Gel (OBG) Eye Drop
• A crosslinked hyaluronic acid (CMHA-S) for
corneal wounds and epitheliopathies
5. 5
Hyaluronic Acid
Properties
High-molecular weight HA is non-immunogenic
High-molecular weight HA binds up to 1,000
times its volume in water weight
HA provides: hydration, lubrication of joints, and
a meshwork for cell migration
RegulatoryApprovals
U.S. – Dermatology & Osteoarthritis
Ex-U.S. – Dry Eye & Wound Healing
HA approved in the U.S. as a device for wound and burn management and
injections to treat knee pain caused by osteoarthritis
Low concentration formulations of HA eye drops (0.1% to 0.4%) are the standard of care
in Europe and Asia for ocular wound healing, dry eye and ocular surface damage
Hyaluronic acid (HA) is a naturally occurring
compound in the body
~15 grams of HA in an adult human body
Possesses unique properties such as hydration
(synovial fluid) and promotion of wound healing
(skin): ideal for ocular surface
Issue: rapidly degrades, one-third is naturally turned-
over (degraded and synthesized) every day
6. First and only eye drop candidate in the U.S. targeting acceleration of re-epithelialization
6
EyeGate’s CMHA-S Platform:
A unique crosslinked version of Hyaluronic acid
Crosslinking creates a 3D structure that stabilizes the molecule (resists degradation)
Prolonged residency time on the ocular surface (90 to 120 minutes)
Higher viscosity/shear rate – thins with blinking and is non blurring
Scaffolding matrix - protects the ocular surface
Enables potential development of a high concentration HA eye drop (0.75%) for treating a wide
variety of ocular surface pathologies from dry eye to wound healing
Crosslinking - Prevents Degradation and Increases Ocular Surface Retention
Crosslinked HAHyaluronic acid
7. Commercially available as a veterinary device
Manufactured by SentrX Animal Care
Sold in the U.S. and certain European countries by Bayer Animal Health as Remend® Corneal
Repair1
5 years in thousands of dogs, cats and horses, with an excellent efficacy/safety profile
1. EyeGate has human ophthalmic rights only. Visit http://www.bayerdvm.com/show.aspx/remend-cross-linking-video
Demonstrated efficacy and safety in animals
7
EyeGate Ocular Bandage Gel (OBG)
A. Non-healing at 42 days
Efficacy of CMHA-S has been demonstrated in various animal pathologic conditions
Post traumatic corneal stromal ulcers (real world dogs and cats)
Corneal abrasion and alkali burn injuries (rabbit models)
Dry eye (veterinary dogs who failed topical cyclosporine)
BA
Molly: 12 year old cat with a non-healing corneal defect
B. Ulcer healing after 12 days of using 0.75% CMHA-S
8. CMHA-S treated cornea exhibited “more
normal” epithelial and stromal organization
8
Healing Corneal Abrasions and Alkali Burns
Efficacy Study: Rabbits1
1. Guanghui Yang, Ladan Espandar, Nick Mamalis and Glenn D. Prestwich, Veterinary Ophthalmology 2010
Histology of alkali burn healing
A. Control at Day 12 central wound with unhealed corneal epithelium
B. CMHA-S treated central epithelium and corneal stroma showing a better
organization than control
A.Fluorescein staining of corneal epithelial abrasions
B.Quantitative analysis at 24 hours; 49% vs 83% complete
P < 0.01
Abrasion: Wound closure complete by 48
hours with CMHA-S
Burns: Complete re-epithelization at Day 12
for CMHA-S but not for control
CMHA-S treated central corneal epithelium
exhibited a faster wound closure
9. Meeting with FDA (Nov 2016) confirms de novo 510(k) filing path
9
OBG Eye Drop Regulated as a Device
Two indications: Photorefractive Keratectomy and Punctate Epitheliopathies
No predicate device – label determined by clinical trials
• Superiority claim must be supported by pivotal trial against standard-of-care
• Pilot trial required to determine powering of superiority for pivotal trial
Initial claim discussed: acceleration of re-epithelization of corneal wounds/defects
• PRK is an excellent homogenous model for measuring time to corneal wound repair
Broadening indication for use (IFU) can be pursued without a pivotal trial
• A trial that demonstrates benefit based on size of defect and not a specific indication is sufficient:
a superiority claim against standard of care not necessary
Development plan includes additional superiority claim: reduction in corneal staining
• Punctate Epitheliopathy (PE) ideal group for epitheliopathies
• Aligns with moderate dry eye
10. Completed First Human Clinical Trial in PRK Patients
10
CMHA-S Eye Drop Accelerates
Corneal Surface Re-Epithelialization
PRK surgery provides several advantages as indication to evaluate the Ocular Bandage Gel (OBG)
A homogenous patient population with same size, large epithelial defects
39 subjects randomized to one of three groups: both eyes received the same treatment
i) OBG alone (ii) OBG + Bandage Contact Lens (BCL) (iii) Standard of care (BCL + Artificial Tears)
OBG alone demonstrates accelerated wound healing vs standard of care
30% more patients healed by Day 3
Additionally, wound size was as much as ~36% smaller as early as Day 1 (24 hours post surgery) with
OBG alone
Targeting Initiation of Pilot PRK Study First Half 2018 with Top-line Data 3 months later
11. 11
Management of Punctate Epitheliopathy
Pilot Trial Design
PE as defined by fluorescein staining of cornea: NEI scale
• Randomization: NEI score between 5 and 12
50 subjects for 2 arm trial: 25 subjects per arm
• Safety will include both eyes (N = 60)
28 Day trial: 2 week wash-out/run-in followed by 2 weeks of two arms
• Day -14 screening: all subjects stop all topicals and take Refresh PF artificial tears QID
OU for 14 days
• Day 0 randomization: OBG QID for 14 days vs Refresh PF artificial tears QID OU for 14
days
Primary performance outcome:
• Change in NEI corneal staining score from baseline to Day 14 between OBG arm and
artificial tears arm for the study eye
Targeting Moderate Dry Eye Patients with Top-line Data expected Q3 2018
12. Corneal foreign bodies
Abrasions / contusions
Chemical burns
Difficult to heal alkali burns (PCED)
12
EyeGate Ocular Bandage Gel (OBG)
Market Opportunity
Refractive surgeries (PRK)
Vitrectomies (Diabetics)
Collagen crosslinking
Pre-cataract surgery
Corneal Wounds and Epitheliopathies: U.S. Numbers
Ocular / Systemic
Disorders:
>55.0 million
(~0.9 million
prescriptions)
Epithelial injury
(exposure):
~16.0 million
(~2.2 million
prescriptions)
Ocular trauma:
~1.8 million
(~0.14 million
prescriptions)
Surgery:
>4.0 million
(~0.2 million
prescriptions)
1. Source: American Academy of Ophthalmology (https://www.aao.org/newsroom/eye-health-statistics)
EyeGate’s proprietary crosslinking provides unique differentiation
Targeting data from next PRK trial and PE trial in first half of 2018, with anticipated filing of de novo
510(k) by year-end 2018
Neurotrophic keratitis (Herpes,
Diabetes)
Contact lens wear
Ocular irritants
Dry Eye
Episodic / mild
Moderate
Severe
13. 13
FDA Comments on IDE
Received comments back from FDA on filed IDE:
can’t move into clinic till resolved
Majority of comments relate to manufacturing validation
• Evaluate manufacturing process to eliminate sources which contribute to excessive bioburden
levels:
• implement QC procedures
• repeat bioburden testing to achieve acceptable limits
• summarize investigative/corrective actions
• Provide alert and action levels for device components prior to filter sterilization
• Provide description of validation protocol and bacterial retention results for sterilizing grade filters
• Provide percent recovery results for bioburden test methods
• Validate gamma irradiation dose range for device packaging
Other
• Include validated analytical methods to identify and quantify impurities and degradation products
• In addition to Ames test conducted provide an additional genotox study
14. Iontophoresis Delivery Platform
• Post Cataract Surgery
• Treatment of Anterior Uveitis
• Next Generation Contact Lens Drug Delivery
• Treatment of Macular Edema
15. Small electrical current propels drug into the eye
Dose controlled by Current (mA) x application time
Improves compliance: reduces applications by almost 98% (2 treatments vs ~154 eye drops)
More than 2,400 treatments performed to date by ophthalmologists and optometrists (<5 minutes)
Utilizes standard of care dexamethasone steroid as active ingredient
A non-invasive method of propelling charged active compounds into ocular tissues
15
Iontophoresis Delivery Platform
16. Etiology assault based (cataract surgery) vs
primarily auto-immune (anterior uveitis)
Inflammation of uveal tissue including iris
and/or ciliary body
Inflammation severity determined by
number of white blood cells in the anterior
chamber of the eye (slit-lamp used)
Primary end-point is proportion of subjects
with zero cells in EGP-437 arm vs control arm
Dexamethasone: a potent anti-inflammatory corticosteroid
16
Non-compliance leads to sight-threatening complications
Iontophoresis Delivery Platform
17. Corticosteroid eye drops: Standard of care for both indications
17
EGP-437: A Highly Differentiated Product
Dramatically Reduces Patient Burden
2 to 3 EyeGate treatments Up to 154 eye drop treatments
VS
18. Worldwide exclusive licenses to manufacture, sell, distribute and commercialize EGP-437 delivered
with Iontophoresis EG II Delivery System for Cataract Surgery and Uveitis only
$135M in potential payments, including up-front, development & commercial milestones
Cataract : $4M up-front, up to $99M dev. & commercial milestones (February 2017)
Anterior Uveitis: $1M up-front, up to $32.5M dev. & commercial milestones (July 2015)
High single digit royalties based on net sales: upward adjustment to double-digit based on
sales for cataract surgery
EyeGate responsible for completion of the clinical development and FDA filing for both indications
Valeant responsible for development outside U.S.
Valeant has right of last refusal for product outside of licensed fields
18
Iontophoresis Delivery Platform
Partnered with a Leading Opthalmic Company
19. Cataract Surgery
The most common surgical procedure
performed by ophthalmic surgeons
Iontophoresis Delivery Platform
20. 20
Iontophoresis Delivery Platform
Cataract Surgery Market Opportunity
Cataract surgery incidence: ~4 million1 annually in U.S. in 2015
Likely to double (following incidence rates) by 2050
Source: National Institute of Health - National Eye Institute
1. Market Scope, 2015 Comprehensive Report on The Global IOL Market, June 2015
Source: J Cataract Refract Surg. 2013 Sep; 39(9): 1383–1389.
2015 Cataract surgery incidence: ~4M in U.S., ~20M Worldwide1
Number of surgeries has increased steadily…
…and could double by 2050 following
projected cataract incidence growth.
21. Double-Masked, Placebo (vehicle)-Controlled, Two-arms: 101 subjects from 7 sites
• 51 Randomized to EGP-437 (Iontophoresis with 40 mg/mL Dexamethasone Phosphate)
• 50 Randomized to Placebo (Iontophoresis with 100 mM Sodium Citrate solution)
EGP-437 demonstrated better clinical performance than vehicle control
• Trending towards statistical significance
21
Inflammation post Cataract Surgery
Phase 2 Trial Highlights
5.9%
13.7%
27.5%
43.1%
52.9%
4.0%
10.0%
24.0%
32.0%
36.0%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
Day 1 Day 4 Day 7 Day 14 Day 28
Proportion with ACC=0
EGP-437 (N=51) Vehicle (N=50)
p = 0.08
22. 22
Additional Information
Phase 2 Trial Highlights
Secondary endpoints: change in mean cell count and change in mean pain score
• EGP-437 showed statistically significant improvements in both ACC count and pain score
• ACC count = 0 on Day 7: p = 0.0096
• Pain Score = 0 on Day 1: p = 0.0149
EGP-437 arm demonstrated a favorable safety profile with no serious adverse events
reported.
Greater percentage of subjects in the placebo were rescued: > 50% by Day 14
• No subjects were rescued after Day 14 in the EGP arm thus demonstrating sustainability of effect
out to Day 28
23. 23
Comparing to Durezol*
13.7%
27.5%
43.1%
52.9%
4.7%
22.4%
41.1%
60.7%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
Day 4 Day 7 Day 14 Day 28
Proportion with ACC=0 (Active Arms)
EGP-437 (N=51)
Durezol (N=107)
9.8%
23.5%
31.4%
35.3%
0.9%
7.7%
11.4%
20.9%
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
30.0%
35.0%
40.0%
Day 4 Day 7 Day 14 Day 28
Proportion with ACC=0 (Placebo Arms)
EGP Vehicle (N=50)
Durezol Placebo (N=220)
There was no Durezol arm in our
study but we compared to FDA filing
material
Compared to Durezol, the EGP arm
performed very similar
EGP vehicle performed significantly
better than historical Durezol
placebo control
*CDER Medical Review (Application #22-212): combined results from the 2 pivotal studies
25. 25
Iontophoresis Delivery Platform
Anterior Uveitis Market Opportunity
EyeGate II Iontophoresis System reduces dosing burden by 98% from standard eye drops
2015 Anterior Uveitis incidence: ~26.6 to 102 per 100,000 annually in U.S.
Incidence of Anterior Uveitis in the U.S. 2008-2016
0
80,000
160,000
240,000
320,000
2008 2009 2010 2011 2012 2013 2014 2015 2016
Uveitis low Uveitis high
Source: JAMA Ophthalmol. 2016 Nov 1;134(11):1237-1245
26. EGP-437 demonstrated safe and effective in reducing inflammation vs positive control
26
Iontophoresis Delivery Platform
Positive Anterior Uveitis Phase 3 Non-Inferiority Trial Results
1. ITT = Intent to Treat
2. Primary End Point (PEP): Total cell clearing (ACC) at Day 14
Successfully demonstrated similar response to standard of care (corticosteroid eye
drops - prednisolone acetate 1%)
Lower incidence of increased intraocular pressure (IOP) with EGP-437 treatment
Confirmatory Phase 3 trial ongoing: Top-line data expected Q3 2018
28. Macular Edema (ME): Abnormal thickening of macula
associated with accumulation of excess fluid within the
neurosensory retina
Iontophoresis delivers efficacious quantities of EGP-437 to back of eye
28
Iontophoresis Delivery Platform
Macular Edema - Non-Invasive Delivery to Retina
Number DME RVO CME
Phakic 9 6 3
Pseudophakic 9 4 3 2
Efficacy: one-third of subjects responded
Positive response from all subtypes (DME, RVO,
and CME)1
Excellent Safety: No increase in IOP
Enrollment completed
Under review for further development
Value in preventing CME post cataract surgery
1. CME: cystoid macular edema, DME: diabetic macular edema, RVO: retinal vein occlusion
30. 30
First indication: dexamethasone for macular edema
Two layer lens:
Layer 1: Sits on surface of eye – loaded with drug
Layer 2: Sits on top of Layer 1 – incorporates
iontophoresis electronics
In vitro work nearing completion, anticipate proof-of-
concept animal data in 2018
Treating chronic retinal conditions at home
Potential to revolutionize the treatment of retinal disease
by significantly reducing or eliminating dangerous
intravitreal injections and frequent office visits!
Iontophoresis and Drug Embedded in a Contact Lens
Iontophoresis Delivery Platform
Drug Embedded Contact Lens for Macular Edema
31. Development Timeline
Program Disease Area 2017 2018 2019 2020
Large Corneal Wounds
Photorefractive Keratectomy (PRK)
Punctate Epitheliopathies
Focus: Moderate Dry Eye
OBG (+ corticosteroids) Eye Drop
Crosslinked Hyaluronic Acid
Punctate Epitheliopathies
Focus: Severe Dry Eye
Anterior Uveitis
Cataract Surgery
Iontophoresis Contact Lens
EGP-437 (Corticosteroid)
Macular Edema
OBG Eye Drop
Crosslinked Hyaluronic Acid
Iontophoresis Delivery System
EGP-437 (Corticosteroid)
Preclinical Work
IND
Ph 1b/2a Trial Ph 2b Trial
Pilot Trial
Pivotal Trial
Pilot Trial
PoC Trial
IDE Work
Pivotal Trial
Launch
de novo
510(k)
Phase 3 Trial
NDA/510(k)
Phase 2b Trial Data Analysis
Launch
Development Work
IND Ph 1b/2a Trial
Preclinical Work
32. 32
Year-to-Date (Q3) 2017 Financial Results
Cash through mid-2018 & multiple late-stage clinical
trial data readouts
($000 except per share)
Revenue $407
R&D Expense $7,253
G&A Expense $3,541
Net Loss $10,387
Net Loss per Share $0.78
Weighted Avg. Shares O/S 13,268
No. Shares O/S 17,205
Cash & Equivalents $9,245
2017 YtD
9/30/2017
33. Two platforms in the clinic with two FDA filings expected in 2018
33
Two Product Platforms for Eye Disorders
Ocular Bandage Gel (OBG) Eye Drop:
Disrupting Dry Eye and Corneal Wound Market
EyeGate II Iontophoresis Delivery System:
Delivering a Corticosteroid (EGP-437)
Disease Area Preclin POC Pilot Pivotal
Large Corneal Wounds
Photorefractive Keratectomy
Punctate Epitheliopathies
Focus: Moderate Dry Eye
Punctate Epitheliopathies
Focus: Severe Dry Eye
OBG + Corticosteroid
Disease Area Preclin Ph 1b/2a Ph 2b Ph 3
Anterior Uveitis
Cataract Surgery
Contact Lens
Macular Edema