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DE-102 (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.

Santen Pharmaceutical’s pipeline candidate, DE-102 (betamethasone), is a steroid microsphere drug undergoing Phase II/III studies in Japan for the treatment of DME and ME-BRVO. Betamethasone is a potent steroid of the glucocorticoid class, with both anti-inflammatory and immunosuppressive properties. In preclinical studies, DE-102 demonstrated sustained efficacy when injected around the affected area, prompting Santen to develop the drug using a new delivery technology.

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 DE-102 including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for DE-102 for the top country from 2013 to 2023.
- Sales information covered for 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 DE-102 performance.
- Obtain sales forecast for DE-102 from 2013-2023 in top country (Japan).

Table Of Contents

DE-102 (Macular Edema and Macular Degeneration) - Forecast and Market Analysis to 2023
1 Table of Contents
2 Introduction 11
2.1 Related Reports 12
3 Disease Overview 14
3.1 Macular Degeneration Overview 14
3.1.1 Etiology and Pathophysiology 16
3.1.2 Classification 20
3.1.3 Symptoms and Diagnosis 22
3.2 Macular Edema Overview 25
3.2.1 Etiology and Pathophysiology 26
3.2.2 Classification 29
3.2.3 Symptoms and Diagnosis 30
4 Disease Management 33
4.1 Diagnosis and Treatment Overview 33
4.1.1 Macular Edema Diagnosis 33
4.1.2 Macular Degeneration Diagnosis 33
4.1.3 Treatment Guidelines and Leading Prescribed Drugs 34
4.1.4 Clinical Practice 36
5 Competitive Assessment 50
5.1 Overview 50
6 Unmet Need and Opportunity 52
6.1 Overview 52
6.2 Treatment for Dry AMD 53
6.2.1 Unmet Need 53
6.2.2 Gap Analysis 55
6.2.3 Opportunity 57
6.3 Longer-Acting Anti-VEGF Drug Therapy 59
6.3.1 Unmet Need 59
6.3.2 Gap Analysis 61
6.3.3 Opportunity 61
6.4 Increased Efficacy of Anti-VEGF Therapy for wAMD 62
6.4.1 Unmet Need 62
6.4.2 Gap Analysis 63
6.4.3 Opportunity 64
6.5 Less Invasive Drug Formulations 64
6.5.1 Unmet Need 64
6.5.2 Gap Analysis 65
6.5.3 Opportunity 66
6.6 Awareness and Earlier Patient Diagnosis 67
6.6.1 Unmet Need 67
6.6.2 Gap Analysis 68
6.6.3 Opportunity 68
6.7 Home Monitoring of AMD Progression 69
6.7.1 Unmet Need 69
6.7.2 Gap Analysis 70
6.7.3 Opportunity 71
7 Pipeline Assessment 73
7.1 Overview 73
7.2 Promising Drugs in Clinical Development 74
8 DE-102 77
8.1 Overview 77
8.2 Efficacy 79
8.3 Safety 79
8.4 Dosing and Formulation 79
8.5 Potential Clinical and Commercial Positioning 80
8.6 SWOT Analysis 81
8.7 Forecast 82
9 Appendix 83
9.1 Bibliography 83
9.2 Abbreviations 97
9.3 Methodology 101
9.4 Forecasting Methodology 101
9.4.1 Diagnosed ME and AMD Patients 101
9.4.2 Percentage of Drug-Treated Patients 102
9.4.3 General Pricing Assumptions 102
9.4.4 Pricing of Pipeline Agents 103
9.5 Primary Research - KOLs Interviewed for this Report 103
9.6 Primary Research - High-Prescribers Survey 104
9.7 About the Authors 105
9.7.1 Analyst 105
9.7.2 Therapy Area Director 105
9.7.3 Global Head of Healthcare 106
9.8 About GlobalData 107
9.9 Disclaimer 107

1.1 List of Tables

Table 1: ARM System Classification of AMD 21
Table 2: Symptoms of AMD 22
Table 3: National and International Treatment Guidelines for ME and AMD 35
Table 4: Most Prescribed Drugs for ME and AMD in the Global Markets, 2013 36
Table 5: Leading Treatments for ME and AMD, 2014 51
Table 6: Unmet Needs and Opportunities in ME and AMD 53
Table 7: Promising Drugs in Clinical Development for ME and AMD 74
Table 8: Comparison of Drugs in Development for ME and AMD, 2014 75
Table 9: Product Profile - DE-102 78
Table 10: DE-102 SWOT Analysis, 2014 81
Table 11: Global Sales Forecast ($m) for DE-102, 2013-2023 82
Table 12: Surveyed High-Prescribing Physicians (Non-KOLs), by Country 104

1.2 List of Figures

Figure 1: Anatomy of the Eye and Macula 14
Figure 2: Amsler Grid viewed by Patient with Normal Vision and with wAMD 23
Figure 3: Color Fundus Photographs of Dry and Wet AMD 23
Figure 4: FAF Imaging of GA 24
Figure 5: Imaging of wAMD 25
Figure 6: CMT in DME 31
Figure 7: RVOs (BRVO and CRVO) on an FA 31
Figure 8: Increased CRT in ME-RVO 32
Figure 9: ME Clinical Treatment Flowchart 42
Figure 10: AMD Clinical Treatment Flowchart 49
Figure 11: Competitive Assessment of Late-Stage Pipeline Agents in ME and AMD, 2013-2023 76
Figure 12: DE-102's Clinical Development in DME and ME-BRVO 78
Figure 13: Clinical and Commercial Positioning of DE-102 80

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