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  4. > Eylea (Macular Edema and Macular Degeneration) - Forecast and Market Analysis to 2023

Eylea (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.

Eylea (aflibercept) is a recombinant fusion protein co-developed by Regeneron and Bayer AG. Eylea acts as a VEGF inhibitor and is approved for the treatment of wAMD and ME-CRVO in all 7MM, and for DME in the US and EU. The developers are also attempting to gain approval for Eylea for DME in Japan, and for ME-BRVO throughout in the EU and Japan.

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 Eylea including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Eylea for the top seven countries from 2013 to 2023.
- Sales information covered for the US, France, Germany, Italy, Spain, the 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 Eylea performance.
- Obtain sales forecast for Eylea from 2013-2023 in top seven countries (the US, France, Germany, Italy, Spain, the UK and Japan).

Table Of Contents

Eylea (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 Eylea (aflibercept) 51
6.1 Overview 51
6.2 Efficacy - Macular Degeneration 56
6.3 Efficacy - Macular Edema 56
6.4 Safety 58
6.5 SWOT Analysis 60
6.6 Forecast 60
7 Appendix 62
7.1 Bibliography 62
7.2 Abbreviations 75
7.3 Methodology 79
7.4 Forecasting Methodology 79
7.4.1 Diagnosed ME and AMD Patients 79
7.4.2 Percentage of Drug-Treated Patients 80
7.4.3 General Pricing Assumptions 80
7.4.4 Individual Drug Assumptions 81
7.5 Primary Research - KOLs Interviewed for this Report 82
7.6 Primary Research - High-Prescribers Survey 83
7.7 About the Authors 84
7.7.1 Analyst 84
7.7.2 Therapy Area Director 84
7.7.3 Global Head of Healthcare 85
7.8 About GlobalData 86
7.9 Disclaimer 86

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: Approval Dates for Eylea 54
Table 7: Product Profile - Eylea 55
Table 8: Eylea — Common Adverse Reactions 59
Table 9: Eylea SWOT Analysis, 2014 60
Table 10: Global Sales Forecast ($m) for Eylea, 2013-2023 61
Table 11: Surveyed High-Prescribing Physicians (Non-KOLs), by Country 83

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 31
Figure 8: Increased CRT in ME-RVO 31
Figure 9: ME Clinical Treatment Flowchart 41
Figure 10: AMD Clinical Treatment Flowchart 48
Figure 11: Eylea's Clinical Development in DME and ME-BRVO 55

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