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