Optic Nerve Disorders Drug Development Pipeline Review, 2018

This report provides an overview of the pipeline landscape for disorders of the optic nerve, the bundle of nerve fibers that transmits visual information from the eye to the brain. It provides comprehensive information on the therapeutics under development and key players involved in therapeutic development for optic neuropathy, glaucoma, Leber’s hereditary optic neuropathy (LHON) and optic neuritis, and features dormant and discontinued products.

Optic neuropathy is an inherited form of vision loss. Symptoms include eye pain or discomfort, numbness, tingling and clouding of vision. There are 10 products in development for this indication.

Glaucoma is a disease of the eye in which fluid pressure within the eye rises. The exact cause of optic nerve damage from glaucoma is not fully understood, but involves mechanical compression and/or decreased blood flow of the optic nerve. Signs and symptoms include eye pain, nausea and vomiting (accompanying the severe eye pain), sudden onset of visual disturbance, often in low light, blurred vision and reddening of the eye. There are 13 products in development for this indication.

LHON is an inherited form of vision loss. This condition usually begins in a person’s teens or twenties. Males are affected much more often than females. Symptoms include eye pain or discomfort, numbness, tingling and clouding of vision. There are 16 products in development for this indication.

Optic neuritis refers to inflammation of the optic nerve. Symptoms include pain, vision loss, dyschromatopsia (impaired ability to perceive colors) and flashing lights. There are 12 products in development for this indication.

Molecular targets acted on by products in development for optic nerve disorders include kinases, growth factors and cannabinoid receptors. Companies operating in this pipeline space include NicOx SA Regeneron Pharmaceuticals and Amgen.

Scope

– Which companies are the most active within each pipeline?

– Which pharmaceutical approaches are the most prominent at each stage of the pipeline and within each indication?

– To what extent do universities and institutions play a role within this pipeline, compared to pharmaceutical companies?

– What are the most important R&D milestones and data publications to have happened in this disease area?

Reasons to buy

- Understand the overall pipeline, with an at-a-glance overview of all products in therapeutic development for each indication

- Assess the products in development in granular detail, with an up-to-date overview of each individual pipeline program in each indication and a comprehensive picture of recent updates and milestones for each

- Analyze the companies, institutions and universities currently operating in the pipeline and the products being fielded by each of these

- Understand the composition of the pipeline in terms of molecule type, molecular target, mechanism of action and route of administration

Companies mentioned

Neuritis

AC Immune SA

Aerie Pharmaceuticals Inc

Alkeus Pharmaceuticals Inc

Allergan Plc

Altacor Ltd

Amarantus Bioscience Holdings Inc

Annexon Inc

Astellas Pharma Inc

Bactevo Ltd

Bial – Portela & Ca SA

BioAxone BioSciences Inc

Bionure Farma SL

Biovista Inc

Can-Fite BioPharma Ltd

Cellix Bio Pvt Ltd

Certa Therapeutics Pty Ltd

Chong Kun Dang Pharmaceutical Corp

coma

Commence Bio Inc

D. Western Therapeutics Institute Inc

Disarm Therapeutics Inc

Dompe Farmaceutici SpA

Elsalys Biotech SA

EyePoint Pharmaceuticals Inc

Eyevensys SAS

Fortify Therapeutics Inc

Fortress Biotech Inc

Gene Signal International SA

GenSight Biologics SA

Glaukos Corp

Graybug Vision Inc

Han Wha Pharma Co Ltd

Handok Inc

HitGen LTD

ID Pharma Co Ltd

InMed Pharmaceuticals Inc

Inspyr Therapeutics Inc

Ironwood Pharmaceuticals Inc

Isarna Therapeutics GmbH

Ixchel Pharma LLC

Khondrion BV

Kowa Co Ltd

Kukje Pharmaceutical Industry Co Ltd

Laboratorios SALVAT SA

Laboratorios Sophia SA de CV

Lee’s Pharmaceutical Holdings Ltd

Lipocure Ltd

Meta-IQ ApS

MimeTech Srl

Mitobridge Inc

Mitochon Pharmaceuticals Inc

Mitotech SA

Nemus Bioscience Inc

Neurim Pharmaceuticals Ltd

NicOx SA

NoNO Inc

Novaliq GmbH

Novartis AG

Ocular Therapeutix Inc

Oculis ehf

Ohr Pharmaceutical Inc

Oncolys BioPharma Inc

Pivot Pharmaceuticals Inc

Profarma

Q BioMed Inc

Regenera Pharma Ltd

ReNetX Bio

Santen Pharmaceutical Co Ltd

Santhera Pharmaceuticals Holding AG

Senju Pharmaceutical Co Ltd

Shire Plc

Spark Therapeutics Inc

Stealth BioTherapeutics Inc

Sun Pharma Advanced Research Company Ltd

Sylentis SAU

Taejoon Pharm Co Ltd

Teijin Pharma Ltd

TikoMed AB

Unity Biotechnology Inc

Table of Contents

1 Table of Contents

1 Table of Contents 4

1.1 List of Tables 4

1.2 List of Figures 8

2 Introduction 9

2.1 Optic Nerve Disorders Report Coverage 9

2.2 Optic Neuropathy - Overview 9

2.3 Glaucoma - Overview 9

2.4 Leber’s Hereditary Optic Neuropathy (Leber Optic Atrophy) - Overview 9

2.5 Optic Neuritis - Overview 9

3 Therapeutics Development 10

3.1 Optic Neuropathy 10

3.2 Glaucoma 13

3.3 Leber’s Hereditary Optic Neuropathy (Leber Optic Atrophy) 24

3.4 Optic Neuritis 28

4 Therapeutics Assessment 31

4.1 Optic Neuropathy 31

4.2 Glaucoma 37

4.3 Leber’s Hereditary Optic Neuropathy (Leber Optic Atrophy) 47

4.4 Optic Neuritis 52

5 Companies Involved in Therapeutics Development 58

5.1 Optic Neuropathy 58

5.2 Glaucoma 60

5.3 Leber’s Hereditary Optic Neuropathy (Leber Optic Atrophy) 91

5.4 Optic Neuritis 97

6 Dormant Projects 101

6.1 Optic Neuropathy 101

6.2 Glaucoma 102

6.3 Leber’s Hereditary Optic Neuropathy (Leber Optic Atrophy) 106

6.4 Optic Neuritis 107

7 Discontinued Products 108

7.1 Optic Neuropathy 108

7.2 Glaucoma 108

7.3 Optic Neuritis 110

8 Product Development Milestones 111

8.1 Optic Neuropathy 111

8.2 Glaucoma 117

8.3 Leber’s Hereditary Optic Neuropathy (Leber Optic Atrophy) 128

8.4 Optic Neuritis 143

9 Appendix 146

9.1 Methodology 146

9.2 Coverage 146

9.3 Secondary Research 146

9.4 Primary Research 146

9.5 Expert Panel Validation 146

9.6 Contact Us 147

9.7 Disclaimer 147

List of Tables

1.1 List of Tables

Table 1: Number of Products under Development for Optic Neuropathy 10

Table 2: Number of Products under Development by Companies, Optic Neuropathy 11

Table 3: Number of Products under Development by Universities/Institutes, Optic Neuropathy 12

Table 4: Products under Development by Companies, Optic Neuropathy 12

Table 5: Products under Development by Universities/Institutes, Optic Neuropathy 13

Table 6: Number of Products under Development for Glaucoma 13

Table 7: Number of Products under Development by Companies, Glaucoma 14

Table 8: Number of Products under Development by Universities/Institutes, Glaucoma 17

Table 9: Products under Development by Companies, Glaucoma 18

Table 10: Products under Development by Universities/Institutes, Glaucoma 23

Table 11: Number of Products under Development for Leber’s Hereditary Optic Neuropathy (Leber Optic Atrophy) 24

Table 12: Number of Products under Development by Companies, Leber’s Hereditary Optic Neuropathy (Leber Optic Atrophy) 25

Table 13: Number of Products under Development by Universities/Institutes, Leber’s Hereditary Optic Neuropathy (Leber Optic Atrophy) 26

Table 14: Products under Development by Companies, Leber’s Hereditary Optic Neuropathy (Leber Optic Atrophy) 26

Table 15: Products under Development by Universities/Institutes, Leber’s Hereditary Optic Neuropathy (Leber Optic Atrophy) 27

Table 16: Number of Products under Development for Optic Neuritis 28

Table 17: Number of Products under Development by Companies, Optic Neuritis 29

Table 18: Number of Products under Development by Universities/Institutes, Optic Neuritis 30

Table 19: Products under Development by Companies, Optic Neuritis 30

Table 20: Products under Development by Universities/Institutes, Optic Neuritis 30

Table 21: Number of Products by Stage and Target, Optic Neuropathy 32

Table 22: Number of Products by Stage and Mechanism of Action, Optic Neuropathy 33

Table 23: Number of Products by Stage and Route of Administration, Optic Neuropathy 35

Table 24: Number of Products by Stage and Molecule Type, Optic Neuropathy 36

Table 25: Number of Products by Stage and Target, Glaucoma 38

Table 26: Number of Products by Stage and Mechanism of Action, Glaucoma 41

Table 27: Number of Products by Stage and Route of Administration, Glaucoma 45

Table 28: Number of Products by Stage and Molecule Type, Glaucoma 47

Table 29: Number of Products by Stage and Target, Leber’s Hereditary Optic Neuropathy (Leber Optic Atrophy) 48

Table 30: Number of Products by Stage and Mechanism of Action, Leber’s Hereditary Optic Neuropathy (Leber Optic Atrophy) 50

Table 31: Number of Products by Stage and Route of Administration, Leber’s Hereditary Optic Neuropathy (Leber Optic Atrophy) 51

Table 32: Number of Products by Stage and Molecule Type, Leber’s Hereditary Optic Neuropathy (Leber Optic Atrophy) 53

Table 33: Number of Products by Stage and Target, Optic Neuritis 54

Table 34: Number of Products by Stage and Mechanism of Action, Optic Neuritis 56

Table 35: Number of Products by Stage and Route of Administration, Optic Neuritis 57

Table 36: Number of Products by Stage and Molecule Type, Optic Neuritis 59

Table 37: Optic Neuropathy – Pipeline by Amgen Inc, H2 2018 60

Table 38: Optic Neuropathy – Pipeline by Ironwood Pharmaceuticals Inc, H2 2018 61

Table 39: Optic Neuropathy – Pipeline by Quark Pharmaceuticals Inc, H2 2018 61

Table 40: Optic Neuropathy – Pipeline by Regenera Pharma Ltd, H2 2018 62

Table 41: Optic Neuropathy – Pipeline by Regeneron Pharmaceuticals Inc, H2 2018 62

Table 42: Glaucoma – Pipeline by AC Immune SA, H2 2018 63

Table 43: Glaucoma – Pipeline by Aerie Pharmaceuticals Inc, H2 2018 63

Table 44: Glaucoma – Pipeline by Allergan Plc, H2 2018 64

Table 45: Glaucoma – Pipeline by Altacor Ltd, H2 2018 64

Table 46: Glaucoma – Pipeline by Amarantus Bioscience Holdings Inc, H2 2018 65

Table 47: Glaucoma – Pipeline by Amgen Inc, H2 2018 65

Table 48: Glaucoma – Pipeline by Annexon Inc, H2 2018 66

Table 49: Glaucoma – Pipeline by Astellas Pharma Inc, H2 2018 66

Table 50: Glaucoma – Pipeline by Bial – Portela & Ca SA, H2 2018 67

Table 51: Glaucoma – Pipeline by BioAxone BioSciences Inc, H2 2018 67

Table 52: Glaucoma – Pipeline by Can-Fite BioPharma Ltd, H2 2018 68

Table 53: Glaucoma – Pipeline by Cellix Bio Pvt Ltd, H2 2018 68

Table 54: Glaucoma – Pipeline by Certa Therapeutics Pty Ltd, H2 2018 68

Table 55: Glaucoma – Pipeline by Chong Kun Dang Pharmaceutical Corp, H2 2018 69

Table 56: Glaucoma – Pipeline by D. Western Therapeutics Institute Inc, H2 2018 70

List of Figures

1.2 List of Figures

Figure 1: Number of Products under Development for Optic Neuropathy 10

Figure 2: Number of Products under Development by Companies, Optic Neuropathy 11

Figure 3: Number of Products under Development for Glaucoma 13

Figure 4: Number of Products under Development by Companies, Glaucoma 14

Figure 5: Number of Products under Development by Universities/Institutes, Glaucoma 17

Figure 6: Number of Products under Development for Leber’s Hereditary Optic Neuropathy (Leber Optic Atrophy) 24

Figure 7: Number of Products under Development by Companies, Leber’s Hereditary Optic Neuropathy (Leber Optic Atrophy) 25

Figure 8: Number of Products under Development for Optic Neuritis 28

Figure 9: Number of Products under Development by Companies, Optic Neuritis 29

Figure 10: Number of Products by Top 10 Targets, Optic Neuropathy 31

Figure 11: Number of Products by Stage and Top 10 Targets, Optic Neuropathy 31

Figure 12: Number of Products by Top 10 Mechanism of Actions, Optic Neuropathy 32

Figure 13: Number of Products by Stage and Top 10 Mechanism of Actions, Optic Neuropathy 33

Figure 14: Number of Products by Routes of Administration, Optic Neuropathy 34

Figure 15: Number of Products by Stage and Routes of Administration, Optic Neuropathy 34

Figure 16: Number of Products by Molecule Types, Optic Neuropathy 35

Figure 17: Number of Products by Stage and Molecule Types, Optic Neuropathy 36

Figure 18: Number of Products by Top 10 Targets, Glaucoma 37

Figure 19: Number of Products by Stage and Top 10 Targets, Glaucoma 37

Figure 20: Number of Products by Top 10 Mechanism of Actions, Glaucoma 40

Figure 21: Number of Products by Stage and Top 10 Mechanism of Actions, Glaucoma 41

Figure 22: Number of Products by Routes of Administration, Glaucoma 44

Figure 23: Number of Products by Stage and Routes of Administration, Glaucoma 45

Figure 24: Number of Products by Top 10 Molecule Types, Glaucoma 46

Figure 25: Number of Products by Stage and Top 10 Molecule Types, Glaucoma 46

Figure 26: Number of Products by Targets, Leber’s Hereditary Optic Neuropathy (Leber Optic Atrophy) 47

Figure 27: Number of Products by Stage and Targets, Leber’s Hereditary Optic Neuropathy (Leber Optic Atrophy) 48

Figure 28: Number of Products by Mechanism of Actions, Leber’s Hereditary Optic Neuropathy (Leber Optic Atrophy) 49

Figure 29: Number of Products by Stage and Mechanism of Actions, Leber’s Hereditary Optic Neuropathy (Leber Optic Atrophy) 49

Figure 30: Number of Products by Routes of Administration, Leber’s Hereditary Optic Neuropathy (Leber Optic Atrophy) 50

Figure 31: Number of Products by Stage and Routes of Administration, Leber’s Hereditary Optic Neuropathy (Leber Optic Atrophy) 51

Figure 32: Number of Products by Molecule Types, Leber’s Hereditary Optic Neuropathy (Leber Optic Atrophy) 52

Figure 33: Number of Products by Stage and Molecule Types, Leber’s Hereditary Optic Neuropathy (Leber Optic Atrophy) 52

Figure 34: Number of Products by Targets, Optic Neuritis 53

Figure 35: Number of Products by Stage and Targets, Optic Neuritis 54

Figure 36: Number of Products by Mechanism of Actions, Optic Neuritis 55

Figure 37: Number of Products by Stage and Mechanism of Actions, Optic Neuritis 55

Figure 38: Number of Products by Routes of Administration, Optic Neuritis 56

Figure 39: Number of Products by Stage and Routes of Administration, Optic Neuritis 57

Figure 40: Number of Products by Molecule Types, Optic Neuritis 58

Figure 41: Number of Products by Stage and Molecule Types, Optic Neuritis 58

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