Squalamine (Macular Edema and Macular Degeneration) – Forecast and Market Analysis to 2023

Pages: 111 Published: October 01, 2014 Report Code: GDHC487DFR

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. Squalamine (Squalamine lactate) is a first-in-class drug being developed by Ohr Pharmaceuticals as a novel eye drop solution treatment for wAMD. This small-molecule drug has a novel intracellular mechanism of action and can potently inhibit multiple protein growth factors involved in angiogenesis, including VEGF, PDGF, and bFGF.

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 Squalamine including product description, safety and efficacy profiles as well as a SWOT analysis.

Sales forecast for Squalamine for the top country from 2013 to 2023.

Sales information covered for the US, France, Germany, Italy, Spain and UK

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 Squalamine performance.

Obtain sales forecast for Squalamine from 2013-2023 in top 6 countries (the US, France, Germany, Italy, Spain and UK).

Table of Contents

1 Table of Contents 6

1.1 List of Tables 9

1.2 List of Figures 10

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 Squalamine 77

8.1 Overview 77

8.2 Efficacy 80

8.3 Safety 81

8.4 Dosing and Formulation 81

8.5 Potential Clinical and Commercial Positioning 82

8.6 SWOT Analysis 83

8.7 Forecast 83

9 Appendix 85

9.1 Bibliography 85

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

List of Tables

Table 1: ARM System Classification of AMD

Table 2: Symptoms of AMD

Table 3: National and International Treatment Guidelines for ME and AMD

Table 4: Most Prescribed Drugs for ME and AMD in the Global Markets, 2013

Table 5: Leading Treatments for ME and AMD, 2014

Table 6: Unmet Needs and Opportunities in ME and AMD

Table 7: Promising Drugs in Clinical Development for ME and AMD

Table 8: Comparison of Drugs in Development for ME and AMD, 2014

Table 9: Product Profile – Squalamine

Table 10: SWOT Analysis – Squalamine, 2014

Table 11: Global Sales Forecast ($m) for Squalamine, 2013–2023

Table 12: Surveyed High-Prescribing Physicians (Non-KOLs), by Country

List of Figures

Figure 1: Anatomy of the Eye and Macula

Figure 2: Amsler Grid viewed by Patient with Normal Vision and with wAMD

Figure 3: Color Fundus Photographs of Dry and Wet AMD

Figure 4: FAF Imaging of GA

Figure 5: Imaging of wAMD

Figure 6: CMT in DME

Figure 7: RVOs (BRVO and CRVO) on an FA

Figure 8: Increased CRT in ME-RVO

Figure 9: ME Clinical Treatment Flowchart

Figure 10: AMD Clinical Treatment Flowchart

Figure 11: Competitive Assessment of Late-Stage Pipeline Agents in ME and AMD, 2013–2023

Figure 12: Squalamine’s Clinical Development in wAMD and DME

Figure 13: Clinical and Commercial Positioning of Squalamine

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