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Emixustat (Macular Edema and Macular Degeneration) - Forecast and Market Analysis to 2023

Summary

Macular Edema is a condition where fluid accumulates on the macula, leading to vision impairment or in severe cases even vision loss. The three main types of ME are diabetic macular edema (DME), and macular edema following either a central or branch retinal vein occlusion (ME-CRVO and ME-BRVO). Age-related macular degeneration (AMD) is a painless eye condition which leads to gradual, irreversible, loss of central vision, and is one of the leading causes of blindness among people aged 50 and over in the developed world. Currently the ME and AMD markets are dominated by the use of anti-VEGF monotherapy, however, in recent years, corticosteroid implants have been reaching the ME market which could challenge the stronghold these drugs have in this sector. The AMD market will see the arrival of the first therapies to treat dry AMD, fulfilling a huge unmet need in the management of this retinal disease, and these first-in-class therapies will strongly drive the market growth over the next ten years. The launch of wet AMD adjunctive therapies will also see a significant change in the treatment of AMD patients and have a positive impact on the market growth.

Emixustat hydrochloride (formerly known as ACU-4429) is an orally-dosed VCM that is designed to be selective for rod photoreceptors and is being developed for the treatment of GA associated with dAMD. This was the first internally-developed compound by Acucela, a Seattle-based biotechnology company. Acucela has one issued US patent (No. 7,982,071) and seven pending US patents for emixustat, all of which will expire in or around 2029.

Scope

- Overview of Macular Edema and Macular Degeneration, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on Emixustat including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Emixustat for the top country from 2013 to 2023.
- Sales information covered for the US, France, Germany, Italy, Spain, UK and Japan

Reasons to buy

- Understand and capitalize by identifying products that are most likely to ensure a robust return.
- Stay ahead of the competition by understanding the changing competitive landscape for Macular Edema and Macular Degeneration.
- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential.
- Make more informed business decisions from insightful and in-depth analysis of Emixustat performance.
- Obtain sales forecast for Emixustat from 2013-2023 in top 7 countries (the US, France, Germany, Italy, Spain, UK and Japan).

Table Of Contents

Emixustat (Macular Edema and Macular Degeneration) - Forecast and Market Analysis to 2023
1 Table of Contents
2 Introduction 10
2.1 Related Reports 11
3 Disease Overview 13
3.1 Macular Degeneration Overview 13
3.1.1 Etiology and Pathophysiology 15
3.1.2 Classification 19
3.1.3 Symptoms and Diagnosis 21
3.2 Macular Edema Overview 24
3.2.1 Etiology and Pathophysiology 25
3.2.2 Classification 28
3.2.3 Symptoms and Diagnosis 29
4 Disease Management 32
4.1 Diagnosis and Treatment Overview 32
4.1.1 Macular Edema Diagnosis 32
4.1.2 Macular Degeneration Diagnosis 32
4.1.3 Treatment Guidelines and Leading Prescribed Drugs 33
4.1.4 Clinical Practice 35
5 Competitive Assessment 49
5.1 Overview 49
6 Unmet Need and Opportunity 51
6.1 Overview 51
6.2 Treatment for Dry AMD 52
6.2.1 Unmet Need 52
6.2.2 Gap Analysis 54
6.2.3 Opportunity 56
6.3 Longer-Acting Anti-VEGF Drug Therapy 58
6.3.1 Unmet Need 58
6.3.2 Gap Analysis 60
6.3.3 Opportunity 60
6.4 Increased Efficacy of Anti-VEGF Therapy for wAMD 61
6.4.1 Unmet Need 61
6.4.2 Gap Analysis 62
6.4.3 Opportunity 63
6.5 Less Invasive Drug Formulations 63
6.5.1 Unmet Need 63
6.5.2 Gap Analysis 64
6.5.3 Opportunity 65
6.6 Awareness and Earlier Patient Diagnosis 66
6.6.1 Unmet Need 66
6.6.2 Gap Analysis 67
6.6.3 Opportunity 67
6.7 Home Monitoring of AMD Progression 68
6.7.1 Unmet Need 68
6.7.2 Gap Analysis 69
6.7.3 Opportunity 70
7 Pipeline Assessment 72
7.1 Overview 72
7.2 Promising Drugs in Clinical Development 73
8 Emixustat 76
8.1 Overview 76
8.2 Efficacy 80
8.3 Safety 80
8.4 Dosing and Formulation 80
8.5 Potential Clinical and Commercial Positioning 81
8.6 SWOT Analysis 82
8.7 Forecast 82
9 Appendix 84
9.1 Bibliography 84
9.2 Abbreviations 99
9.3 Methodology 103
9.4 Forecasting Methodology 103
9.4.1 Diagnosed ME and AMD Patients 103
9.4.2 Percentage of Drug-Treated Patients 104
9.4.3 General Pricing Assumptions 104
9.4.4 Pricing of Pipeline Agents 105
9.5 Primary Research - KOLs Interviewed for this Report 106
9.6 Primary Research - High-Prescribers Survey 107
9.7 About the Authors 108
9.7.1 Analyst 108
9.7.2 Therapy Area Director 108
9.7.3 Global Head of Healthcare 109
9.8 About GlobalData 110
9.9 Disclaimer 110

1.1 List of Tables

Table 1: ARM System Classification of AMD 20
Table 2: Symptoms of AMD 21
Table 3: National and International Treatment Guidelines for ME and AMD 34
Table 4: Most Prescribed Drugs for ME and AMD in the Global Markets, 2013 35
Table 5: Leading Treatments for ME and AMD, 2014 50
Table 6: Unmet Needs and Opportunities in ME and AMD 52
Table 7: Promising Drugs in Clinical Development for ME and AMD 73
Table 8: Comparison of Drugs in Development for ME and AMD, 2014 74
Table 9: Product Profile - Emixustat 79
Table 10: SWOT Analysis - Emixustat, 2014 82
Table 11: Global Sales Forecast ($m) for emixustat, 2013-2023 83
Table 12: Surveyed High-Prescribing Physicians (Non-KOLs), by Country 107

1.2 List of Figures

Figure 1: Anatomy of the Eye and Macula 13
Figure 2: Amsler Grid viewed by Patient with Normal Vision and with wAMD 22
Figure 3: Color Fundus Photographs of Dry and Wet AMD 22
Figure 4: FAF Imaging of GA 23
Figure 5: Imaging of wAMD 24
Figure 6: CMT in DME 30
Figure 7: RVOs (BRVO and CRVO) on an FA 30
Figure 8: Increased CRT in ME-RVO 31
Figure 9: ME Clinical Treatment Flowchart 41
Figure 10: AMD Clinical Treatment Flowchart 48
Figure 11: Competitive Assessment of Late-Stage Pipeline Agents in ME and AMD, 2013-2023 75
Figure 12: Emixustat Clinical Development in dAMD 79
Figure 13: Clinical and Commercial Positioning of emixustat 81

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