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Novel Drugs and Devices to Lower Intraocular Pressure, 2016 - 2026

Novel Drugs and Devices to Lower Intraocular Pressure, 2016 - 2026

INTRODUCTION
An imbalance in the production and / or drainage of aqueous humor within the eye is known to lead to an increase in intraocular pressure (IOP). Acutely elevated IOP, a condition broadly known as ocular hypertension, may either lead to the expulsion of ocular contents through a traumatic opening or result in a number of clinical conditions / disorders including glaucoma. Currently available treatment options include ocular hypotensive medications, laser therapy and surgical interventions. However, these treatment modalities are known to be associated with a number of complications and adverse events. Amongst these, poor adherence rates are a major concern in patients who are on ocular hypotensive medications; an estimated 50% of patients do not adhere to the therapeutic regimen prescribed to them. Laser therapies are known to lose their efficacy over time. It has been observed that the disease is controlled only in around 50% of patients who have been treated with some form of laser therapy; the effect usually wears off after a period of five years. Traditional surgical procedures, such as filtration procedures, glaucoma drainage devices (GDDs) and cyclodestructive procedures, are also known to have various risks and complications associated with them. Therefore, in the current scenario, multiple challenges exist as far as the treatment of elevated IOP is concerned.

A better understanding of the complex pathways involved in aqueous humor dynamics has resulted in the identification of many novel targets for maintaining ocular homeostasis. These novel targets have led to the development of a number of innovative therapeutic options for lowering elevated IOP. Specifically, to address poor patient compliance, a number of players are developing sustained release devices (implants, punctal plugs or contact lenses) so that the patient is not required to self-medicate on a regular basis. Similarly, the landscape of surgical interventions is also witnessing a lot of change with the emergence of safer, reproducible and less invasive treatment options. These novel surgical interventions include minimally-invasive glaucoma surgery (MIGS), blebless ab externo glaucoma surgery (BAGS), ab externo bleb surgery (ABS), minimally invasive micro sclerostomy (MIMS), non-penetrating glaucoma surgery (NPGS) and non-invasive glaucoma procedure (NIGP).

SCOPE OF THE REPORT
The ‘Novel Drugs and Devices to Lower Intraocular Pressure, 2016 - 2026’ report provides an extensive study of the emerging market of such novel drugs, devices and surgical procedures for the treatment of elevated IOP. The focus of this study is on the applications of these novel treatment options, both marketed and under development, and their likely mid to long term evolution. These treatment options claim to provide consistent benefits related to IOP lowering and are anticipated to gain widespread adoption in the foreseen future.

The report covers various aspects of this market; some of these are outlined below:
A detailed assessment of the current market landscape of novel drugs and devices, key players involved, the status of development of various pipeline products and the target patient segments.
Comprehensive profiles covering mechanism of action, clinical trial details and associated developments of Rho-associated protein kinase (ROCK) inhibitors, ROCK / norepinephrine transporter (NET) inhibitors and NO donating prostaglandins in late stage of development.
Comprehensive profiles highlighting the IOP reduction approach, key performance drivers, safety and efficacy of novel surgical procedures that have been approved or are in advanced stages of development.
Comparative analysis of MIGS devices based on various parameters such as drainage route, length of the implant, involvement of conjunctiva, type of procedure (ab interno or ab externo), procedure duration and ability of the device to treat 360 degrees.
An informed view on the likely future evolution of such novel drugs, sustained release drug delivery devices and surgical procedures over the next decade. This includes sales forecasts of six novel drugs, including Rhopressa, Roclatan and Vesneo. Similarly, we have presented our view on the future market size of six drug delivery devices, including Bimatoprost SR, OTX-TP and punctal plug delivery system. We have also determined the likely future revenues for MIGS and non-MIGS surgical devices (BAGS, ABS, NIGP and NPGS).

To account for the uncertainties in the market, we have provided three market forecast scenarios that represent three different tracks of the market’s evolution. Given the current unmet need for safer and more effective therapeutic options and the rich pipeline of novel drugs and devices, we expect this market to witness significant growth in the coming few years.

Our opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with Bob Butchofsky (Founder and CEO, Mati Therapeutics), Suzana Nahum Zilberberg (CEO, Bio-Light Life Sciences), Ronen Castro (CEO, IOPtima) and Donald Schwartz (CEO and President, Eye Sonix).

EXAMPLE HIGHLIGHTS
1. Glaucoma is the second leading cause of blindness, worldwide, after cataract. It is estimated that, by 2020, around 79.6 million people in the world will have glaucoma. Specifically, in the US, it is estimated that, by 2020, 4 million people will have glaucoma with 50% cases left undiagnosed.
2. Currently available treatment options (ocular hypotensive medications, laser therapy and surgical interventions) are associated with a number of complications and adverse events. Known drawbacks include poor patient compliance, loss of adequate response, intolerable ocular and systemic adverse effects, and degradation of quality of life.
3. Rho-associated protein kinase (ROCK) inhibitors, ROCK / norepinephrine transporter (NET) inhibitors, adenosine receptor agonists, adenosine A3 receptor antagonists and Nitric oxide (NO) donors have emerged as novel drug classes in this field. In fact, one drug (Glanatec from Kowa Company) is already available in the Japanese market; more than 20 are in clinical development and rest are in the preclinical / discovery phase.
4. Examples of players with candidate molecules in the late stages development include Aerie Pharmaceuticals (Rhopressa™ and Roclatan™), Inotek Pharmaceuticals (Trabodenoson), Santen Pharmaceutical (DE-117) and Valeant Pharmaceuticals (Vesneo™). In addition, a number of other start-ups are exploring the potential in this domain.
5. 13 novel drug delivery devices are under development as sustained release systems. Specifically, Bimatoprost SR from Allergan is already in Phase III of clinical development. A number of other devices, currently in early stages of development, are likely to provide a credible alternative to tackle the challenges associated with poor patient compliance.
6. Advances in glaucoma surgery have led to the emergence of several novel surgical devices. There are over 30 novel surgical devices that have been developed / are being developed for the treatment of elevated IOP. MIGS devices currently represent a growing portion of the glaucoma surgery market; these have been shown to provide better results compared to traditional trabeculectomy procedures.
7. Over the course of next ten years, the market for novel drugs is likely to grow at a relatively higher annualized rate of 83.9%. Similarly, we expect significant growth in the market of sustained release drug delivery devices and novel surgical devices. Combined, such novel drugs and devices are expected to cater to over 65% of the total glaucoma market by 2026.

1.1. RESEARCH METHODOLOGY
Most of the data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include
Annual reports
Investor presentations
SEC filings
Industry databases
News releases from company websites
Government policy documents
Industry analysts’ views

While the focus has been on forecasting the market over the coming ten years, the report also provides our view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

1.2. CHAPTER OUTLINES
Chapter 2 provides an executive summary and offers a high level view on where the market for IOP lowering novel drugs and devices is headed in the mid to long term.

Chapter 3 is a general introduction to IOP and the various diseases associated with elevated IOP. It contains detailed discussions on aqueous humor dynamics and the various factors responsible for an increase in IOP. The chapter also outlines the currently available treatment modalities for IOP related diseases and their shortcomings.

Chapter 4 includes information on novel drugs that are either already available or being evaluated in different stages of development for the treatment of IOP. In this chapter, we have presented a comprehensive pipeline of all such products that we identified during our research. It presents an analysis of the aforementioned pipeline based on a number of different parameters, including phase of development, mechanism of action, disease sub-type, route of administration and dosage schedule.

Chapter 5 presents information on the various types of novel devices (surgical and drug delivery devices) that are either already available in the market or being evaluated in different stages of development. Similar to the previous chapter, we have presented a comprehensive pipeline of all relevant devices that we came across during our research. The chapter provides an analysis of the pipeline based on the phase of development of the product, its purpose, the category of devices it belongs to and the approach / pathway it employs for IOP reduction. In addition, we have added a separate section on drug delivery devices highlighting details such as the type of drug delivered and the nature of implant (biodegradable or non-biodegradable).

Chapter 6 provides detailed company profiles of the prominent players that are involved in investigating novel drugs for the treatment of elevated IOP. Each company profile includes a brief overview of the company, its financial information, key performance drivers, and its future outlook and strategy. In addition, the profiles cover details of late stage candidate therapies, such as Rho-associated protein kinase (ROCK) inhibitors, ROCK / norepinephrine transporter (NET) inhibitors and NO donating prostaglandins, which are being evaluated for the treatment of elevated IOP. These details include an overview of the product, its mechanism of action, collaborations / partnerships specific to the particular drug, key developmental events and the associated clinical trials landscape.

Chapter 7 provides details on some of the important players involved in the development of MIGS and BAGS devices. Each company profile includes a brief overview of the company, funding instances, financial information, key performance drivers, and its future outlook and strategy. In addition, the profiles cover details of company’s approved / clinical stage devices. These details include a brief overview of the product, its specifications (size, shape, material and surgical procedure used to insert the device into the eye), the IOP reduction approach it follows, details of its clinical studies, and efficacy and safety data.

Chapter 8 offers a comprehensive perspective on how the market for novel drugs and devices in this field is likely to evolve over the next ten years. In this chapter, we have forecasted the sales of six novel drugs, including Rhopressa, Roclatan and Vesneo. Similarly, we have presented our view on the future market size of six drug delivery devices, which include Bimatoprost SR, OTX-TP and punctal plug delivery system. We have also determined the likely future revenues for MIGS and non-MIGS devices (BAGS, ABS, NIGP and NPGS). Due to uncertainties surrounding some of the key assumptions made within our forecast model, we have presented three different evolutionary scenarios for the overall market, namely the base, conservative and optimistic scenarios.

Chapter 9 provides information on MIGS devices covering the salient features that distinguish them from traditional surgical interventions. The chapter includes an overview of the current market landscape of MIGS devices and presents an approval timeline highlighting all the approved devices of this nature. We have also presented a comparative spider web analysis of MIGS devices (for both approved and under development devices) based on different parameters, such as drainage route, length of the implant, involvement of conjunctiva, type of procedure (ab interno or ab externo), duration of the procedure, the ability to treat entire Schlemm’s canal and the target patient segment.

Chapter 10 summarizes the overall report. In this chapter, we have provided a recap of the key takeaways and our independent opinion regarding the market based on the research and analysis described in the previous chapters.

Chapter 11 is a collection of interview transcripts of our discussions with some of the key players in this industry. We have presented the details of our conversations with Bob Butchofsky (Founder and CEO, Mati Therapeutics), Suzana Nahum Zilberberg (CEO, Bio-Light Life Sciences), Ronen Castro (CEO, IOPtima) and Donald Schwartz (CEO and President, Eye Sonix).

Chapters 12 and 13 are appendices, which provide tabulated data and a list of companies that are mentioned in the report.

LIST OF COMPANIES AND ORGANIZATIONS

The following companies and organizations have been mentioned in the report
1. AC Immune
2. ACADIA Pharmaceuticals
3. Acorn Biomedical
4. Actavis
5. Aerie Pharmaceuticals
6. Alcon Laboratories
7. Alcon Research
8. Allegro Investment Fund
9. Allergan
10. Allysta Pharmaceuticals
11. Alta Partners
12. Altacor
13. Amakem Therapeutics
14. Amgen
15. Amorphex Therapeutics
16. Amoun Pharmaceutical
17. AqueSys
18. Ascension Health Ventures
19. Ascension Ventures
20. AYUMI Pharmaceutical
21. Bascom Palmer Eye Institute
22. Bausch & Lomb
23. Bayer
24. Beaver-Visitec International
25. Belgian Investment Federal Fund
26. BioAxone BioSciences
27. Bio-Light Life Sciences
28. BioWin
29. Caisse de depot et placement du Quebec
30. Can-Fite BioPharma
31. Capricorn Health-Tech Fund NV
32. Care Capital
33. Clarus Ventures
34. Coherent
35. Coronis Partners
36. Cristalens
37. Crown Venture Fund
38. D. Western Therapeutics Institute
39. D.O.R.C. International
40. Deerfield Management Company
41. Delphi Ventures
42. Dendreon
43. Device Technologies
44. Devon Park Bioventures
45. EDBI
46. Ellex
47. Ellex iScience
48. Envisia Therapeutics
49. Ergo-Prevent
50. EVS Glaucoma Therapeutics
51. Eye Sonix
52. Eye Tech Care
53. Financière Spin-off Luxembourgeoise (INVESTSUD Group)
54. Fond Européen des Matériaux
55. Foresite Capital
56. Forest Laboratories
57. ForSight VISION5
58. Fuji Laboratory
59. GBS Ventures
60. GlaucoPharm
61. Glaukos
62. Glautec
63. Graybug Vision
64. Handok
65. Healionics Corporation
66. Hercules Technology Growth Capital
67. Hicks Equity Partners
68. Horizon Technology Finance Corporation
69. Hospital Clinico San Carlos
70. Hoya Group
71. Icon Bioscience
72. InMed Pharmaceuticals
73. InnFocus
74. Innovative Therapie und Diagnostik GmbH
75. Inotek Pharmaceuticals
76. InSite Vision
77. International Medical Distribution
78. InView Medical
79. IOPtima
80. Iridex Corporation
81. Isarna Therapeutics
82. iScience Interventional
83. Iskowitz Instrumental SRL
84. iSTAR Medical
85. Ivantis
86. Kadmon
87. Kala Pharmaceuticals
88. Kowa Company
89. Leo Lens Technology
90. Lexicon Pharmaceuticals
91. Makina Optik Ticaret
92. Marathon
93. Mati Therapeutics
94. McGee Eye Institute
95. MedImmune Ventures
96. Medisurg
97. Meditor Capital Management
98. MemorialCare Innovation Fund
99. Merck & Co.
100. MicroOptx Medical
101. Miller School of Medicine
102. Mitsubishi UFJ Capital
103. Namur Invest - Preface
104. NEMUS Bioscience
105. Neomedix
106. New Enterprise Associates
107. New World Medical
108. NicOx
109. Novaliq GmbH
110. Novartis
111. Ocular Therapeutix
112. Oculis Pharma
113. OftalMedica srl
114. OHR Pharmaceutical
115. Ono Pharmaceuticals
116. OphthaliX
117. Ophthalmos
118. Osage University
119. Otsuka Pharmaceutical
120. Oxford BioMedica
121. Palobiofarma
122. Peregrine Ophthalmic
123. Pfizer
124. Pioneer Pharma
125. Pitango Venture Capital
126. New Enterprise Associates (NEA)
127. Polyactiva
128. pSivida
129. Radikal Therapeutics
130. Ramot at Tel Aviv University
131. Regeneron
132. Replenish
133. Rheon Medical
134. Rho Ventures
135. Roche
136. Rosellini Scientific Benelux
137. Saints Capital Everest
138. Salix
139. Sanoculis
140. Sanofi
141. Santen Pharmaceutical
142. Scientific Health Development Partners
143. Senju Pharmaceutical
144. Shire
145. Showa Yakuhin
146. Sight Sciences
147. Société Régionale d'Investissement de Wallonie (SRIW)
148. Sofinnova Ventures
149. SOLX
150. STAAR Surgical
151. Sun Pharma company
152. Sylentis
153. Technomix SA
154. Tisbury Pharmaceuticals
155. Tokyo New Drug Research Laboratories
156. TPG Biotech
157. Transcend Medical
158. Ube Industries
159. University of Miami
160. University of Oklahoma
161. University of Washington
162. Valeant Pharmaceuticals International
163. Vertex Ventures
164. Wakamoto
165. Yotsuya Shirato Eye Clinic


1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Overview
3.2. Structure of the Eye
3.3. Aqueous Humor Dynamics
3.3.1. Aqueous Humor Production
3.3.2. Aqueous Humor Drainage
3.4. Factors Responsible for Elevated IOP
3.5. Diseases Associated with Elevated IOP
3.5.1. Ocular Hypertension
3.5.2. Glaucoma
3.5.3. Retinal Artery Occlusion
3.6. Treatment Options: Ocular Hypertension and Glaucoma
3.6.1. Medical Treatment
3.6.2. Laser Therapy
3.6.2.1. Argon Laser Trabeculoplasty (ALT)
3.6.2.2. Selective Laser Trabeculoplasty (SLT)
3.6.3. Surgical Treatment
3.7. Drawbacks of Currently Available Treatment Options
3.7.1. Drawbacks of Medical Treatment
3.7.2. Drawbacks of Laser Therapy
3.7.3. Drawbacks of Surgical Treatment
3.8. Novel Therapeutic Targets for Lowering IOP
3.9. Novel Devices for Lowering IOP
3.9.1. Novel Surgical Devices
3.9.2. Novel Sustained Release Drug Delivery Devices
4. MARKET LANDSCAPE: NOVEL DRUGS
4.1. Chapter Overview and Scope
4.2. Novel Drugs to Treat Elevated IOP: Clinical and Preclinical Pipeline
4.2.1. Novel Drugs to Treat Elevated IOP: Analysis by Highest Phase of Development
4.2.2. Novel Drugs to Treat Elevated IOP: Analysis by Mechanism of Action
4.2.3. Novel Drugs to Treat Elevated IOP: Analysis by Disease Sub-type
4.2.4. Novel Drugs to Treat Elevated IOP: Analysis by Route of Administration
4.2.5. Novel Drugs to Treat Elevated IOP: Analysis by Dosing Schedule
5. MARKET LANDSCAPE: NOVEL DEVICES
5.1. Chapter Overview
5.2. Novel Devices to Treat Elevated IOP: Pipeline Analysis
5.2.1. Novel Devices to Treat Elevated IOP: Analysis by Highest Phase of Development
5.2.2. Novel Devices to Treat Elevated IOP: Analysis by Purpose of the Device
5.2.3. Novel Devices to Treat Elevated IOP: Analysis by Category of the Device
5.2.4. Novel Devices to Treat Elevated IOP: Analysis by Approach / Pathway for IOP Reduction
5.2.5. Sustained Release Drug Delivery Devices
6. COMPANY AND DRUG PROFILES
6.1. Chapter Overview
6.2. Aerie Pharmaceuticals
6.2.1. Company Overview
6.2.2. Funding
6.2.3. Future Outlook
6.2.4. Product Profile: Rhopressa™ (AR-13224 / Netarsudil Mesylate)
6.2.4.1. Drug Specification
6.2.4.2. Mechanism of Action
6.2.4.3. Key Development Events
6.2.5. Product Profile: Roclatan™ (PG324)
6.2.5.1. Drug Specification
6.2.5.2. Mechanism of Action
6.2.5.3. Key Development Events
6.3. Inotek Pharmaceuticals
6.3.1. Company Overview`
6.3.2. Funding
6.3.3 Future Outlook
6.3.4. Product Profile: Trabodenoson (INO-8875)
6.3.4.1. Drug Specification
6.3.4.2. Mechanism of Action
6.3.4.3. Key Development Events
6.4. Kowa Company
6.4.1. Company Overview
6.4.2 Future Outlook
6.4.3. Product Profile: Glanatec™ (Ripasudil / K-115)
6.4.3.1. Drug Specification
6.4.3.2. Mechanism of Action
6.4.3.3. Collaboration with D. Western Therapeutics Institute
6.4.3.4. Key Development Events
6.5. Santen Pharmaceutical
6.5.1. Company Overview
6.5.2. Financial Performance
6.5.3. Future Outlook
6.5.4. Product Profile: DE-117
6.5.4.1. Drug Specification
6.5.4.2. Mechanism of Action
6.5.4.3. Collaboration with Ube Industries
6.5.4.4. Key Development Events
6.5.5. Product Profile: Sepetaprost (ONO-9054 / DE-126)
6.5.5.1. Drug Specification
6.5.5.2. Mechanism of Action
6.5.5.3. Collaboration with Ono Pharmaceutical
6.5.5.4. Key Development Events
6.6. Valeant Pharmaceuticals International
6.6.1. Company Overview
6.6.2. Financial Performance
6.6.3. Future Outlook
6.6.4. Product Profile: Vesneo™ (Latanoprostene Bunod)
6.6.4.1. Drug Specification
6.6.4.2. Mechanism of Action
6.6.4.3. Collaboration with NicOx
6.6.4.4. Key Development Events
7. COMPANY AND DEVICE PROFILES
7.1. Chapter Overview
7.2. Alcon (a Novartis Company)
7.2.1. Company Overview
7.2.2. Acquisition of Transcend Medical
7.2.3. Financial Information
7.2.4 Future Outlook
7.2.5. CyPass® Micro-Stent
7.2.5.1. Product Overview
7.2.5.2. IOP Reduction Approach
7.2.5.3. Product Specifications
7.2.5.4. Key Development Events
7.2.5.5. Clinical Studies
7.2.5.6. Key Clinical Results
7.3. Allergan
7.3.1. Company Overview
7.3.2. Acquisition of AqueSys
7.3.3. Financial Information
7.3.4. Future Outlook
7.3.5. XEN™ Gel Stent
7.3.5.1. Product Overview
7.3.5.2. IOP Reduction Approach
7.3.5.3. Product Specifications
7.3.5.4. Clinical Studies
7.3.5.5. Key Clinical Results
7.4. Ellex
7.4.1. Company Overview
7.4.2. Acquisition of Canaloplasty Business of iScience Interventional
7.4.3. Financial Information
7.4.4. Future Outlook
7.4.5. iTrack™ 250A (to Perform Traditional Canaloplasty)
7.4.5.1. Product Overview
7.4.5.2. IOP Reduction Approach
7.4.5.3. Product Specifications
7.4.5.4. Key Clinical Results
7.4.6. iTrack™ 250A (to Perform ABiC)
7.4.6.1. Product Overview
7.4.6.2. Approach of IOP Reduction
7.4.6.3. Product Specifications
7.4.6.4. Key Clinical Results
7.5. Glaukos
7.5.1. Company Overview
7.5.2. Financial Information
7.5.3. Future Outlook
7.5.4. iStent®
7.5.4.1. Product Overview
7.5.4.2. IOP Reduction Approach
7.5.4.3. Product Specifications
7.5.4.4. Key Development Events
7.5.4.5. Clinical Studies
7.5.4.6. Key Clinical Results
7.5.5. iStent inject®
7.5.5.1. Product Overview
7.5.5.2. IOP Reduction Approach
7.5.5.3. Product Specifications
7.5.5.4. Key Development Events
7.5.5.5. Clinical Studies
7.5.5.6. Key Clinical Results
7.5.6. iStent Supra®
7.5.6.1. Product Overview
7.5.6.2. IOP Reduction Approach
7.5.6.3. Product Specifications
7.5.6.4. Key Development Events
7.5.6.5. Clinical Studies
7.5.6.6. Key Clinical Results
7.6. InnFocus
7.6.1. Company Overview
7.6.2. Funding
7.6.3. Future Outlook
7.6.4. InnFocus Microshunt™
7.6.4.1. Product Overview
7.6.4.2. IOP Reduction Approach
7.6.4.3. Product Specifications
7.6.4.4. Key Development Events
7.6.4.5. Clinical Studies
7.6.4.6. Key Clinical Results
7.7. iSTAR Medical
7.7.1. Company Overview
7.7.2. Funding
7.7.3. Future Outlook
7.7.4. STARflo™ Glaucoma Implant
7.7.4.1. Product Overview
7.7.4.2. IOP Reduction Approach
7.7.4.3. Product Specifications
7.7.4.4. Key Development Events
7.7.4.5. Regional Collaborations
7.7.4.6. Clinical Studies
7.8. Ivantis
7.8.1. Company Overview
7.8.2. Funding
7.8.3. Future Outlook
7.8.4. Hydrus™ Microstent
7.8.4.1. Product Overview
7.8.4.2. IOP Reduction Approach
7.8.4.3. Product Specifications
7.8.4.4. Key Development Events
7.8.4.5. Clinical Studies
7.8.4.6. Key Clinical Results
7.9. New World Medical
7.9.1. Company Overview
7.9.2. Future Outlook
7.9.3. Kahook Dual Blade™
7.9.3.1. Product Overview
7.9.3.2. IOP Reduction Approach
7.9.3.3. Product Specifications
7.10. Sight Sciences
7.10.1. Company Overview
7.10.2. Funding
7.10.3. Future Outlook
7.10.4. TRAB™360
7.10.4.1. Product Overview
7.10.4.2. IOP Reduction Approach
7.10.4.3. Product Specifications
7.10.4.4. Key Clinical Results
7.10.5. VISCO™360
7.10.5.1. Product Overview
7.10.5.2. IOP Reduction Approach
7.10.5.3. Product Specifications
8. MARKET FORECAST
8.1. Chapter Overview
8.2. Forecast Methodology and Assumptions
8.3. Overall Glaucoma Market, 2016 – 2026
8.3.1. Novel Drugs Market, 2016 – 2026
8.3.1.1. Glanatec™ (Ripasudil / K-115): Sales Forecast
8.3.1.2. Vesneo™ (Latanoprostene bunod): Sales Forecast
8.3.1.3. Rhopressa™ (AR-13224 / Netarsudil Mesylate): Sales Forecast
8.3.1.4. Trabodenoson (INO-8875): Sales Forecast
8.3.1.5. Roclatan™ (PG324): Sales Forecast
8.3.1.6. DE-117: Sales Forecast
8.3.2. Sustained Release Drug Delivery Devices Market
8.3.2.1. Bimatoprost SR: Sales Forecast
8.3.2.2. Helios™ Insert(Bimatoprost Ring): Sales Forecast
8.3.2.3. Punctal Plug Delivery System Sales Forecast
8.3.2.4. ENV 515: Sales Forecast
8.3.2.5. OTX-TP: Sales Forecast
8.3.2.6. iDose™: Sales Forecast
8.3.3. Novel Surgical Devices Market, 2016 – 2026
8.3.3.1. MIGS Devices: Sales Forecast, 2016 – 2026
8.3.3.2. Non-MIGS Devices: Sales Forecast, 2016 – 2026
9. MIGS DEVICES: COMPARATIVE SPIDER WEB ANALYSIS
9.1. Chapter Overview
9.2. MIGS Devices: An Overview
9.3. MIGS Devices: Approval Timeline
9.4. MIGS Devices: Competitive landscape
9.5. Comparative Analysis of MIGS Devices
9.5.1. Comparative Analysis of Implants
9.5.2. Comparative Analysis of Ablation Devices
10. CONCLUSION
10.1. Novel Drug Classes have Recently Emerged for the Management of IOP
10.2. Sustained Release Devices are Expected to Eradicate Compliance Issues
10.3. Microinvasive Surgery has the Potential to Revolutionize Glaucoma Treatment
10.4. Significant Shift is Likely to Occur in the Overall Market Landscape in the Mid-Long Term
10.5. Concluding Remarks
11. INTERVIEW TRANSCRIPTS
11.1. Chapter Overview
11.2. Bob Butchofsky, Founder and CEO, Mati Therapeutics
11.3. Donald Schwartz, CEO and President, Eye Sonix
11.4. Ronen Castro, CEO, IOPtima
11.5. Suzana Nahum Zilberberg, CEO, Bio-Light Life Sciences
12. APPENDIX 1: TABULATED DATA
13. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
LIST OF FIGURES
Figure 3.1 Novel Surgical Devices: Approaches for IOP Reduction
Figure 4.1 Novel Drugs to Treat Elevated IOP: Distribution by Highest Phase of Development
Figure 4.2 Novel Drugs to Treat Elevated IOP: Distribution by Mechanism of Action
Figure 4.3 Novel Drugs to Treat Elevated IOP: Distribution by Disease Sub-type
Figure 4.4 Novel Drugs to Treat Elevated IOP: Distribution by Route of administration
Figure 4.5 Novel Drugs to Treat Elevated IOP: Distribution by Dosing Schedule
Figure 5.1 Novel Devices to Treat Elevated IOP: Distribution by Highest Phase of Development
Figure 5.2 Novel Devices to Treat Elevated IOP: Approved Products in the US and EU
Figure 5.3 Novel Devices to Treat Elevated IOP: Distribution by Purpose of the Device
Figure 5.4 Novel Devices to Treat Elevated IOP: Distribution by Category of the Device
Figure 5.5 Novel Devices to Treat Elevated IOP: Distribution by Approach / Pathway for IOP Reduction
Figure 6.1 Rhopressa™: Clinical Development Timeline
Figure 6.2 Roclatan™: Clinical Development Timeline
Figure 6.3 Trabodenoson: Clinical Development Timeline
Figure 6.4 Glanatec™: Clinical Development Timeline
Figure 6.5 Santen Annual Revenues, FY 2010 – FY 2015 (JPY Billion)
Figure 6.6 DE-117: Clinical Development Timeline
Figure 6.7 Sepetaprost: Clinical Development Timeline
Figure 6.8 Valeant Pharmaceuticals Annual Revenues, 2010 – 2015 (USD Billion)
Figure 6.9 Vesneo™: Clinical Development Timeline
Figure 7.1 Alcon Annual Revenues, 2011 – H1 2016 (USD Billion)
Figure 7.2 Allergan Annual Revenues, 2011– H1 2016 (USD Billion)
Figure 7.3 Ellex Annual Revenues, FY 2011 – FY 2015 (USD Million)
Figure 7.4 Glaukos Annual Revenues, 2013 – H1 2016 (USD Million)
Figure 8.1 Overall Glaucoma Market: Distribution by Treatment Modalities, 2016 – 2026, Base Scenario (USD Billion)
Figure 8.2 Glaucoma Market: Share of Different Treatment Options 2016, 2021, and 2026 (Base Scenario)
Figure 8.3 Novel Drugs Market, 2016 – 2026: Base Scenario (USD Billion)
Figure 8.4 Glanatec™ (Ripasudil / K-115) Sales Forecast: Base Scenario (USD Billion)
Figure 8.5 Vesneo™ (Latanoprostene Bunod) Sales Forecast, 2017 - 2026: Base Scenario (USD Billion)
Figure 8.6 Rhopressa™ (AR-13224 / Netarsudil Mesylate) Sales Forecast: Base Scenario (USD Billion)
Figure 8.7 Trabodenoson (INO-8875) Sales Forecast: Base Scenario (USD Billion)
Figure 8.8 Roclatan™ (PG324) Sales Forecast: Base Scenario (USD Billion)
Figure 8.9 DE-117 Sales Forecast: Base Scenario (USD Billion)
Figure 8.10 Sustained Release Devices Sales Forecast: Base Scenario (USD Billion)
Figure 8.11 Bimatoprost SR Sales Forecast: Base Scenario (USD Billion)
Figure 8.12 Helios™ Insert (Bimatoprost Ring) Sales Forecast: Base Scenario (USD Billion)
Figure 8.13 Punctal Plug Delivery System Sales Forecast: Base Scenario (USD Billion)
Figure 8.14 ENV515 Sales Forecast: Base Scenario (USD Billion)
Figure 8.15 OTX-TP Sales Forecast: Base Scenario (USD Billion)
Figure 8.16 iDose™ Sales Forecast: Base Scenario (USD Billion)
Figure 8.17 Novel Surgical Devices Market, 2016 – 2026: Base Scenario (USD Billion)
Figure 8.18 MIGS Devices Market, 2016 – 2026: Base Scenario (USD Billion)
Figure 8.19 Non-MIGS Devices Market, 2016 – 2026: Base Scenario (USD Billion)
Figure 8.20 Non-MIGS Devices Market, 2026: Distribution by Device Category
Figure 9.1 MIGS Devices: Approval Timeline
Figure 9.2 MIGS Devices: Comparative Analysis of Implants
Figure 9.3 MIGS Devices: Comparative Analysis of Ablation Devices
Figure 10.1 Glaucoma Therapies Market: Distribution by Treatment Modalities, 2016, 2021, and 2026 (USD Billion)
LIST OF TABLES
Table 3.1 Eye: Description of Tissue Layers
Table 3.2 Currently Available Drugs for Ocular Hypertension and Glaucoma
Table 3.3 Currently Available Fixed Combination Treatments
Table 3.4 Ocular Adverse Reactions by Drug Class
Table 3.5 Systemic Adverse Reactions by Drug Class
Table 3.6 New Therapeutic Targets for Lowering IOP
Table 4.1 Novel Drugs to Treat Elevated IOP: Marketed and Clinical Pipeline
Table 4.2 Novel Drugs to Treat Elevated IOP: Preclinical and Discovery Pipeline
Table 5.1 Novel Devices to Treat Elevated IOP: Pipeline
Table 5.2 Sustained Release Drug Delivery Devices
Table 6.1 Novel Drugs in Advanced Stages of Development
Table 6.2 Aerie Pharmaceuticals: Product Candidates to Treat Elevated IOP
Table 6.3 Kowa’s Pharmaceutical Business Division: Therapeutic Areas and Related Indications
Table 6.4 Santen Pharmaceutical: Novel Product Candidates
Table 7.1 List of Company and Device Profiles
Table 7.2 CyPass® Micro-Stent: Industry Sponsored Clinical Trials
Table 7.3 XEN™ Gel Stent: Industry Sponsored Clinical Trials
Table 7.4 Ellex: Novel IOP Lowering Devices
Table 7.5 Ellex 2015 Sales: Key Market Segments
Table 7.6 Glaukos: IOP Lowering Product Portfolio
Table 7.7 iStent®: Industry Sponsored Clinical Trials
Table 7.8 iStent inject®: Industry Sponsored Clinical Trials
Table 7.9 iStent Supra®: Industry Sponsored Clinical Trials
Table 7.10 InnFocus Microshunt™: Industry Sponsored Clinical Trials
Table 7.11 iSTAR Medical: Devices in Development
Table 7.12 iSTAR Medical: Global Distribution Partners
Table 7.13 Hydrus™ Microstent: Industry Sponsored Clinical Trials
Table 7.14 Sight Sciences: Novel IOP Lowering Devices
Table 8.1 Novel Drugs: Estimated Launch Years
Table 8.2 Sustained Release Drug Delivery Devices: Estimated Launch Years
Table 9.1 MIGS Devices Competitive Landscape
Table 9.2 Comparative Analysis of Implants: Details on Parameters
Table 9.3 Comparative Analysis of Ablation Devices: Details on Parameters
Table 12.1 Novel Drugs to Treat Elevated IOP: Distribution by Highest Phase of Development
Table 12.2 Novel Drugs to Treat Elevated IOP: Distribution by Mechanism of Action
Table 12.3 Novel Drugs to Treat Elevated IOP: Distribution by Disease Sub-type
Table 12.4 Novel Drugs to Treat Elevated IOP: Distribution by Route of administration
Table 12.5 Novel Drugs to Treat Elevated IOP: Distribution by Dosing Schedule
Table 12.6 Novel Devices to Treat Elevated IOP: Distribution by Highest Phase of Development
Table 12.7 Novel Devices: Approved Products in the US and EU
Table 12.8 Novel Devices to Treat Elevated IOP: Distribution by Purpose of the Device
Table 12.9 Novel Devices to Treat Elevated IOP: Distribution by Approach / Pathway for IOP reduction
Table 12.10 Santen Annual Revenues, FY 2010 – FY 2015 (JPY Billion)
Table 12.11 Valeant Pharmaceuticals Annual Revenues, 2010 – 2015 (USD Billion)
Table 12.12 Alcon Annual Revenues, 2011 – H1 2016 (USD Billion)
Table 12.13 Allergan Annual Revenues, 2011- H1 2016 (USD Billion)
Table 12.14 Ellex Annual Revenues, FY 2011 – FY 2015 (USD Million)
Table 12.15 Glaukos Annual Revenues, 2013 – H1 2016 (USD Million)
Table 12.16 Overall Glaucoma Market: Distribution by Treatment Modalities, 2016 – 2026, Base Scenario (USD Billion)
Table 12.17 Overall Glaucoma Market: Distribution by Treatment Modalities, 2016 – 2026, Optimistic Scenario (USD Billion)
Table 12.18 Overall Glaucoma Market: Distribution by Treatment Modalities, 2016 – 2026, Conservative Scenario (USD Billion)
Table 12.19 Glaucoma Market: Share of Different Treatment Options 2016, 2021, and 2026 (Base Scenario)
Table 12.20 Glaucoma Market: Share of Different Treatment Options 2016, 2021, and 2026 (Optimistic Scenario)
Table 12.21 Glaucoma Market: Share of Different Treatment Options 2016, 2021, and 2026 (Conservative Scenario)
Table 12.22 Novel Drugs Market, 2016 – 2026: Base Scenario (USD Billion)
Table 12.23 Novel Drugs Market, 2016 – 2026: Optimistic Scenario (USD Billion)
Table 12.24 Novel Drugs Market, 2016 – 2026: Conservative Scenario (USD Billion)
Table 12.25 Glanatec™ (Ripasudil / K-115) Sales Forecast: Base Scenario (USD Billion)
Table 12.26 Glanatec™ (Ripasudil / K-115) Sales Forecast: Optimistic Scenario (USD Billion)
Table 12.27 Glanatec™ (Ripasudil / K-115) Sales Forecast: Base Scenario (USD Billion)
Table 12.28 Vesneo™ (Latanoprostene bunod) Sales Forecast: Base Scenario (USD Billion)
Table 12.29 Vesneo™ (Latanoprostene bunod) Sales Forecast: Optimistic Scenario (USD Billion)
Table 12.30 Vesneo™ (Latanoprostene bunod) Sales Forecast: Conservative Scenario (USD Billion)
Table 12.31 Rhopressa™ (AR-13224 / Netarsudil Mesylate) Sales Forecast: Base Scenario (USD Billion)
Table 12.32 Rhopressa™ (AR-13224 / Netarsudil Mesylate) Sales Forecast: Optimistic Scenario (USD Billion)
Table 12.33 Rhopressa™ (AR-13224 / Netarsudil Mesylate) Sales Forecast: Conservative Scenario (USD Billion)
Table 12.34 Trabodenoson (INO-8875) Sales Forecast: Base Scenario (USD Billion)
Table 12.35 Trabodenoson (INO-8875) Sales Forecast: Optimistic Scenario (USD Billion)
Table 12.36 Trabodenoson (INO-8875) Sales Forecast: Conservative Scenario (USD Billion)
Table 12.37 Roclatan™ (PG324) Sales Forecast: Base Scenario (USD Billion)
Table 12.38 Roclatan™ (PG324) Sales Forecast: Optimistic Scenario (USD Billion)
Table 12.39 Roclatan™ (PG324) Sales Forecast: Conservative Scenario (USD Billion)
Table 12.40 DE-117 Sales Forecast: Base Scenario (USD Billion)
Table 12.41 DE-117 Sales Forecast: Optimistic Scenario (USD Billion)
Table 12.42 DE-117 Sales Forecast: Conservative Scenario (USD Billion)
Table 12.43 Sustained Release Devices Sales Forecast: Base Scenario (USD Billion)
Table 12.44 Sustained Release Devices Sales Forecast: Optimistic Scenario (USD Billion)
Table 12.45 Sustained Release Devices Sales Forecast: Conservative Scenario (USD Billion)
Table 12.46 Bimatoprost SR Sales Forecast: Base Scenario (USD Billion)
Table 12.47 Bimatoprost SR Sales Forecast: Optimistic Scenario (USD Billion)
Table 12.48 Bimatoprost SR Sales Forecast: Conservative Scenario (USD Billion)
Table 12.49 Helios™ Insert (Bimatoprost Ring) Sales Forecast: Base Scenario (USD Billion)
Table 12.50 Helios™ Insert (Bimatoprost Ring) Sales Forecast: Optimistic Scenario (USD Billion)
Table 12.51 Helios™ Insert (Bimatoprost Ring) Sales Forecast: Conservative Scenario (USD Billion)
Table 12.52 Punctal Plug Delivery System Sales Forecast: Base Scenario (USD Billion)
Table 12.53 Punctal Plug Delivery System Sales Forecast: Optimistic Scenario (USD Billion)
Table 12.54 Punctal Plug Delivery System Sales Forecast: Conservative Scenario (USD Billion)
Table 12.55 ENV515 Sales Forecast: Base Scenario (USD Billion)
Table 12.56 ENV515 Sales Forecast: Optimistic Scenario (USD Billion)
Table 12.57 ENV515 Sales Forecast: Conservative Scenario (USD Billion)
Table 12.58 OTX-TP Sales Forecast: Base Scenario (USD Billion)
Table 12.59 OTX-TP Sales Forecast: Optimistic Scenario (USD Billion)
Table 12.60 OTX-TP Sales Forecast: Conservative Scenario (USD Billion)
Table 12.61 iDose™ Sales Forecast: Base Scenario (USD Billion)
Table 12.62 iDose™ Sales Forecast: Optimistic Scenario (USD Billion)
Table 12.63 iDose™ Sales Forecast: Conservative Scenario (USD Billion)
Table 12.64 Novel Surgical Devices Market, 2016 – 2026: Base Scenario (USD Billion)
Table 12.65 Novel Surgical Devices Market, 2016 – 2026: Optimistic Scenario (USD Billion)
Table 12.66 Novel Surgical Devices Market, 2016 – 2026: Conservative Scenario (USD Billion)
Table 12.67 MIGS Devices Market, 2016 – 2026: Base Scenario (USD Billion)
Table 12.68 MIGS Devices Market, 2016 – 2026: Optimistic Scenario (USD Billion)
Table 12.69 MIGS Devices Market, 2016 – 2026: Conservative Scenario (USD Billion)
Table 12.70 Non-MIGS Devices Market, 2016 – 2026: Base Scenario (USD Billion)
Table 12.71 Non-MIGS Devices Market, 2016 – 2026: Optimistic Scenario (USD Billion)
Table 12.72 Non-MIGS Devices Market, 2016 – 2026: Conservative Scenario (USD Billion)
Table 12.73 Non-MIGS Devices Market, 2026: Distribution by Device Category
Table 12.74 Glaucoma Therapies Market: Distribution by Treatment Modalities, 2016, 2021, and 2026 (USD Billion)

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