Frontier Pharma: Ophthalmology Therapeutics - Gene Therapies and First-in-Class Targets Offer Novel Treatments for Substantial Unmet Needs in a Pipeline Dominated by Angiogenic and Immune Signaling Drugs

Frontier Pharma: Ophthalmology Therapeutics - Gene Therapies and First-in-Class Targets Offer Novel Treatments for Substantial Unmet Needs in a Pipeline Dominated by Angiogenic and Immune Signaling Drugs

Summary

The ophthalmologic therapy area encompasses a wide range of disorders affecting the eye and its supporting structures. These include glaucoma, age-related macular degeneration (AMD), diabetic retinopathy (DR), diabetic macular edema (DME) and dry eye syndrome (DES). The therapy area is characterized by vast unmet need, as patients have few treatment options and poor outcomes.

This report assesses first-in-class innovation in the ophthalmology pipeline, highlighting key trends in the distribution of these products. In-depth analysis reveals that the level of innovation within the therapy area pipeline is high, with strong potential for drugs to address unmet needs and be commercially lucrative. First-in-class drugs account for 38% of products with a disclosed molecular target, acting on 151 unique molecular targets, which is indicative of the approach being taken in the field.

In the past the ophthalmological disorders therapy area has suffered from a lack of full understanding of the pathophysiology and underlying mechanisms of the diseases. However, as this knowledge has improved vastly in recent years, potential targets have been identified for treatment. As well as the main disorders previously mentioned, there is also interest in developing treatments for indications such as allergic conjunctivitis and retinitis pigmentosa. The approval of a gene therapy for retinitis pigmentosa is indicative of this progress, and represents the first gene therapy approved for an inherited condition by the FDA.

The pipeline is varied in terms of molecular targets and molecule types. Products acting on the immune system and neurotransmitter signaling are the most prevalent, but no single target dominates by any clear margin. There are a total of 194 first-in class pipeline products in development for ophthalmologic indications - 38% of the 512 pipeline products for which there is a disclosed molecular target. Encompassing gene therapies, slowing of the visual cycle and antisense therapies, the pipeline appears robust and has huge potential to strengthen treatment options for ophthalmological disorders.

Scope

- The pipeline is large, with 865 products in active development. Does current pipeline innovation hold the potential to affect the future ophthalmology market?
- There are 194 first-in-class products in the ophthalmologic disorder pipeline. Which of these possess the greatest potential to improve disease outcome and be commercially successful, based on their target?
- Analysis of strategic consolidations and deals revealed a high level of activity in recent years for licensing agreements, but a low level of co-development. How do deal frequency and value compare between molecular targets and molecule types, and which first-in-class targets have not yet been involved in deals?

Reasons to buy

- Understand the current clinical and commercial landscape. This includes a comprehensive study of disease pathogenesis, diagnosis and prognosis, and the treatment options available.
- Visualize the composition of the ophthalmological disorders market in terms of dominant molecule types and targets, and understand the current unmet needs and how they can be addressed. This knowledge allows a competitive understanding of gaps in the market.
- Analyze the ophthalmological disorders pipeline and stratify by stage of development, molecule type and molecular target. There are strong signs in the pipeline that the industry is seeking novel approaches to treating ophthalmological disorders to overcome the overwhelming level of unmet need.
- Assess the therapeutic potential of first-in-class targets. Using a proprietary matrix, first-in-class products have been assessed and ranked according to clinical potential. Promising early-stage targets have been reviewed in greater detail.
- Identify commercial opportunities in the ophthalmological disorders deals landscape by analyzing trends in licensing and co-development deals, and a curated list of ophthalmological disorder therapies that have not yet been involved in deals, and may offer potential investment opportunities.
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 3
1.2 List of Figures 3
2 Executive Summary 5
2.1 Market Landscape Poised for Entry of Novel Products 5
2.2 Moderately Sized but Strong First-in-Class Pipeline 5
2.3 Strong Uptake of First-in-Class Products in Strategic Consolidations 5
3 The Case for Innovation 6
3.1 Growing Opportunities for Biologic Products 7
3.2 Diversification of Molecular Targets 7
3.3 Innovative First-in-Class Product Development Remains Attractive 7
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 8
3.5 Sustained Innovation 8
3.6 GBI Research Report Guidance 9
4 Clinical and Commercial Landscape 10
4.1 Therapy Area Overview 10
4.1.1 Glaucoma 10
4.1.2 Age-related Macular Degeneration 10
4.1.3 Diabetic Macular Edema 10
4.1.4 Diabetic Retinopathy 10
4.1.5 Dry Eye Syndrome 11
4.1.6 Inherited Genetic Disorders 11
4.2 Disease Symptoms 11
4.3 Epidemiology and Etiology 12
4.3.1 Glaucoma 13
4.3.2 Age-Related Macular Degeneration 13
4.3.3 Diabetic Retinopathy and Diabetic Macular Edema 13
4.3.4 Dry Eye Syndrome 13
4.4 Diagnosis 13
4.5 Pathophysiology 14
4.5.1 Healthy Eye Physiology 14
4.5.2 Glaucoma 15
4.5.3 Age-Related Macular Degeneration 16
4.5.4 Diabetic Macular Edema and Diabetic Retinopathy 17
4.5.5 Dry Eye Syndrome 17
4.5.6 Inherited Genetic Diseases 18
4.6 Prognosis 18
4.6.1 Glaucoma 18
4.6.2 Age-Related Macular Degeneration 19
4.6.3 Diabetic Retinopathy and Diabetic Macular Edema 19
4.6.4 Dry Eye Syndrome 19
4.7 Treatment Options 20
4.8 Overview of Marketed Products in Ophthalmology 22
4.8.1 Molecule Type and Target Analysis 22
5 Assessment of Pipeline Product Innovation 23
5.1 Ophthalmology Pipeline by Molecular Target 26
5.2 Comparative Distribution of Programs between the Ophthalmology Market and Pipeline by Therapeutic Target Family 28
5.3 First-in-Class Pipeline Programs Targeting Novel Molecular Targets 29
6 Signaling Network, Disease Causation and Innovation Alignment 40
6.1 Complexity of Signaling Networks in Ophthalmology 40
6.2 Signaling Pathways and First-in-Class Molecular Target Integration 40
6.3 First-in-Class Matrix Assessment 41
7 First-in-Class Target Evaluation 45
7.1 Pipeline Programs Targeting MER 45
7.2 Pipeline Programs Targeting Rhodopsin 46
7.3 Pipeline Programs Targeting NLRP3 47
7.4 Pipeline Programs Targeting ABCA4 48
7.5 Pipeline Programs Targeting Complement Factor B 48
7.6 Pipeline Programs Targeting RPE65 AND RBP4 50
7.7 Conclusion 52
8 Deals and Strategic Consolidations 53
8.1 Industry-Wide First-in-Class Deals 53
8.2 Licensing Deals 55
8.2.1 Deals by Region, Year and Value 55
8.2.2 Deals by Stage of Development and Value 56
8.2.3 Deals by Molecule Type, Mechanism of Action and Value 56
8.2.4 Table for Licensing Deals Valued Above $100m 58
8.3 Co-development Deals 58
8.3.1 Deals by Region, Year and Value 58
8.3.2 Deals by Stage of Development and Value 60
8.3.3 Deals by Molecule Type, Mechanism of Action and Value 60
8.3.4 Table for Co-development Deals Valued Above $100m 61
8.4 First-in-Class Programs With and Without Prior Deal Involvement 61
9 Appendix 65
9.1 Abbreviations 65
9.2 References 65
9.3 Research Methodology 69
9.4 Primary Research 70
9.5 Secondary Research 70
9.5.1 Market Analysis 70
9.5.2 Pipeline Analysis 70
9.5.3 First-in-Class Matrix Assessment 71
9.5.4 First-in-Class Target Profiles 71
9.5.5 Licensing and Co-development Deals 71
9.6 Contact Us 71
9.7 Disclaimer 71

List Of Tables

1.1 List of Tables
Table 1: Ophthalmology Therapeutics, Global, Main Symptoms of Glaucoma, AMD, DR and DES, 2017 12
Table 2: Ophthalmology Therapeutics, Global, Prevalence of Major Ophthalmologic Disorders, 2017 13
Table 3: Ophthalmology Therapeutics, Global, Treatment Options Available for Glaucoma, 2017 21
Table 4: Ophthalmology Therapeutics, Global, Data for MERTK as a Molecular Target, 2017 46
Table 5: Ophthalmology Therapeutics, Global, Data for RHO as a Molecular Target, 2017 47
Table 6: Ophthalmology Therapeutics, Global, Data for NLRP3 as a Molecular Target, 2017 47
Table 7: Ophthalmology Therapeutics, Global, Data for ABCA4 as a Molecular Target, 2017 48
Table 8: Ophthalmology Therapeutics, Global, Data for Cfb as a Molecular Target, 2017 50
Table 9: Ophthalmology Therapeutics, Global, Data for Serine Protease RPE65 as a Molecular Target, 2017 51
Table 10: Ophthalmology Therapeutics, Global, Data for Serine Protease RBP4 as a Molecular Target, 2017 52

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