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PharmaPoint: Macular Edema and Macular Degeneration - US Drug 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.

The corticosteroid implants Ozurdex and Iluvien are also anticipated to enter the US DME market during the forecast period, with Ozurdex receiving FDA approval as a DME treatment in June 2014, and Iluvien expected to launch in Q1 2015 following it’s approval in September 2014. This new class of drugs is expected to be a significant driver of growth in the overall ME market, and by the end of the forecast period in 2023.

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 the key drugs in the US including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in the US from 2013-2023.
- Analysis of the impact of key events as well the drivers and restraints affecting the US Macular Edema and Macular Degeneration market.

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 drug performance
- Obtain sales forecast for drugs from 2013-2023 in the US

Table Of Contents

PharmaPoint: Macular Edema and Macular Degeneration - US Drug Forecast and Market Analysis to 2023
1 Table of Contents
2 Introduction 13
2.1 Related Reports 14
3 Disease Overview 16
3.1 Macular Degeneration Overview 16
3.1.1 Etiology and Pathophysiology 18
3.1.2 Classification 22
3.1.3 Symptoms and Diagnosis 24
3.2 Macular Edema Overview 27
3.2.1 Etiology and Pathophysiology 28
3.2.2 Classification 31
3.2.3 Symptoms and Diagnosis 32
4 Disease Management 35
4.1 Diagnosis and Treatment Overview 35
4.1.1 Macular Edema Diagnosis 35
4.1.2 Macular Degeneration Diagnosis 35
4.1.3 Treatment Guidelines and Leading Prescribed Drugs 36
4.1.4 Clinical Practice 37
4.2 US 49
5 Competitive Assessment 53
5.1 Overview 53
5.2 Product Profiles - Major Brands 54
5.2.1 Lucentis (ranibizumab) 54
5.2.2 Eylea (aflibercept) 64
5.2.3 Avastin (bevacizumab) 73
5.2.4 Macugen (pegaptanib sodium) 79
5.2.5 Visudyne (verteporfin) 82
5.2.6 Corticosteroid Implants 86
6 Unmet Need and Opportunity 97
6.1 Overview 97
6.2 Treatment for Dry AMD 98
6.2.1 Unmet Need 98
6.2.2 Gap Analysis 100
6.2.3 Opportunity 102
6.3 Longer-Acting Anti-VEGF Drug Therapy 104
6.3.1 Unmet Need 104
6.3.2 Gap Analysis 106
6.3.3 Opportunity 106
6.4 Increased Efficacy of Anti-VEGF Therapy for wAMD 107
6.4.1 Unmet Need 107
6.4.2 Gap Analysis 108
6.4.3 Opportunity 109
6.5 Less Invasive Drug Formulations 109
6.5.1 Unmet Need 109
6.5.2 Gap Analysis 110
6.5.3 Opportunity 111
6.6 Awareness and Earlier Patient Diagnosis 112
6.6.1 Unmet Need 112
6.6.2 Gap Analysis 113
6.6.3 Opportunity 113
6.7 Home Monitoring of AMD Progression 114
6.7.1 Unmet Need 114
6.7.2 Gap Analysis 115
6.7.3 Opportunity 116
7 Pipeline Assessment 118
7.1 Overview 118
7.2 Promising Drugs in Clinical Development 119
7.2.1 Abicipar pegol 121
7.2.2 Fovista 127
7.2.3 Squalamine 135
7.2.4 Lampalizumab 142
7.2.5 Emixustat 148
7.2.6 Optina 154
7.3 Promising Drugs in Early-Stage Development 160
7.3.1 Complement Inhibitors 160
7.4 Other Drugs in Development 163
7.5 Biosimilars 164
8 Market Outlook 166
8.1 US 166
8.1.1 Forecast 166
8.1.2 Key Events 172
8.1.3 Drivers and Barriers - Global Issues 173
8.1.4 US- Drivers and Barriers 176
9 Appendix 179
9.1 Bibliography 179
9.2 Abbreviations 202
9.3 Methodology 207
9.4 Forecasting Methodology 207
9.4.1 Diagnosed ME and AMD Patients 207
9.4.2 Percentage of Drug-Treated Patients 208
9.4.3 Drugs Included in Each Therapeutic Class 208
9.4.4 Launch and Patent Expiry Dates 208
9.4.5 General Pricing Assumptions 209
9.4.6 Individual Drug Assumptions 209
9.4.7 Pricing of Pipeline Agents 213
9.5 Primary Research - KOLs Interviewed for this Report 214
9.6 Primary Research - High-Prescribers Survey 215
9.7 About the Authors 216
9.7.1 Analyst 216
9.7.2 Therapy Area Director 216
9.7.3 Global Head of Healthcare 217
9.8 About GlobalData 218
9.9 Disclaimer 218

1.1 List of Tables

Table 1: ARM System Classification of AMD 23
Table 2: Symptoms of AMD 24
Table 3: National and International Treatment Guidelines for ME and AMD 36
Table 4: Most Prescribed Drugs for ME and AMD in the Global Markets, 2013 37
Table 5: ME and AMD Disease Management - US 52
Table 6: Leading Treatments for ME and AMD, 2014 54
Table 7: Product Profile - Lucentis 59
Table 8: Lucentis SWOT Analysis, 2014 64
Table 9: Approval Dates for Eylea 68
Table 10: Product Profile - Eylea 68
Table 11: Eylea — Common Adverse Reactions 72
Table 12: Eylea SWOT Analysis, 2014 73
Table 13: Product Profile - Avastin 76
Table 14: Avastin SWOT Analysis, 2014 79
Table 15: Product Profile - Macugen 81
Table 16: Product Profile - Visudyne 84
Table 17: Visudyne SWOT Analysis, 2014 86
Table 18: Product Profile - Ozurdex 89
Table 19: Product Profile - Iluvien 93
Table 20: Corticosteroid IVT Implants SWOT Analysis, 2014 96
Table 21: Unmet Needs and Opportunities in ME and AMD 98
Table 22: Promising Drugs in Clinical Development for ME and AMD 119
Table 23: Comparison of Drugs in Development for ME and AMD, 2014 120
Table 24: Product Profile - Abicipar pegol 123
Table 25: SWOT Analysis - Abicipar pegol, 2014 127
Table 26: Product Profile - Fovista 132
Table 27: SWOT Analysis - Fovista, 2014 135
Table 28: Product Profile - Squalamine 139
Table 29: SWOT Analysis - Squalamine, 2014 142
Table 30: Product Profile - Lampalizumab 145
Table 31: SWOT Analysis - Lampalizumab, 2014 148
Table 32: Product Profile - Emixustat 151
Table 33: SWOT Analysis - Emixustat, 2014 154
Table 34: Product Profile - Optina 157
Table 35: SWOT Analysis - Optina, 2014 160
Table 36: Early-Stage Drugs in Clinical Development for ME and AMD, 2014 163
Table 37: Sales Forecast ($m) for ME in the United States, 2013-2023 168
Table 38: Sales Forecast ($m) for AMD in the United States, 2013-2023 170
Table 39: Key Events Impacting Sales for ME and AMD in the US, 2013-2023 172
Table 40: ME and AMD Markets - Drivers and Barriers, 2013-2023 173
Table 41: ME and AMD Markets - Drivers and Barriers in the US, 2013-2023 176
Table 42: Key Launch Dates 208
Table 43: Key Patent Expiries 209
Table 44: Surveyed High-Prescribing Physicians (Non-KOLs), in the US 215

1.2 List of Figures

Figure 1: Anatomy of the Eye and Macula 16
Figure 2: Amsler Grid viewed by Patient with Normal Vision and with wAMD 25
Figure 3: Color Fundus Photographs of Dry and Wet AMD 25
Figure 4: FAF Imaging of GA 26
Figure 5: Imaging of wAMD 27
Figure 6: CMT in DME 33
Figure 7: RVOs (BRVO and CRVO) on an FA 34
Figure 8: Increased CRT in ME-RVO 34
Figure 9: ME Clinical Treatment Flowchart 42
Figure 10: AMD Clinical Treatment Flowchart 49
Figure 11: Eylea's Clinical Development in DME and ME-BRVO 69
Figure 12: Iluvien's and Ozurdex's Clinical Development in wAMD, dAMD, and DME 93
Figure 13: Competitive Assessment of Late-Stage Pipeline Agents in ME and AMD, 2013-2023 121
Figure 14: Abicipar Pegol's Clinical Development in wAMD and DME 124
Figure 15: Clinical and Commercial Positioning of abicipar pegol 126
Figure 16: Fovista's Clinical Development in wAMD 132
Figure 17: Clinical and Commercial Positioning of Fovista 134
Figure 18: Squalamine's Clinical Development in wAMD and DME 139
Figure 19: Clinical and Commercial Positioning of squalamine 141
Figure 20: Lampalizumab's Development in wAMD 145
Figure 21: Clinical and Commercial Positioning of lampalizumab 147
Figure 22: Emixustat Clinical Development in dAMD 151
Figure 23: Clinical and Commercial Positioning of emixustat 153
Figure 24: Optina's Clinical Development in DME 157
Figure 25: Clinical and Commercial Positioning of Optina 159
Figure 26: Individual Drug Sales for ME in the US, 2013-2023 169
Figure 27: Individual Drug Sales for AMD in the US, 2013-2023 171

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