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  4. > Dry Eye Syndrome: Clinical Trial Tracker

Dry Eye Syndrome: Clinical Trial Tracker

  • April 2014
  • -
  • Roots Analysis Private Ltd.

INTRODUCTION

With nearly 300 million dry eye sufferers worldwide, dry eye represents one of the largest ophthalmic indications. It is also known as keratoconjunctivitis sicca. To date, there is no cure for dry eye syndrome, but there are treatments to control its symptoms. The prevalence of dry eye syndrome primarily increases with age, and has an estimated incidence of 15% in persons over the age of 65 years. A greater risk of acquiring dry eye is also experienced by females, with postmenopausal women being particularly at risk.

In the US alone, the economic burden of dry eye totals USD 3.84 billion in direct annual health care costs. After including the indirect costs of lost productivity, the societal burden of dry eye rises to USD 55.4 billion annually in the US. For patients, the average annual direct cost ranges from USD 678 for patients with mild dry eye to USD 1,267 for severe cases. If pharmaceuticals and punctual plugs are included, the cost for these patients rises to USD 2,959 annually. Furthermore, dry eye increases lost productivity through both absenteeism and decreased presenteeism, with the former ranging from 8.4 to 14.2 days per year depending on severity and the latter ranging from 91 to 128.2 days per year depending on severity.

SCOPE OF THE REPORT

The primary objective of this report is to capture details on the various clinical and preclinical trials which are currently underway in the field of dry eye. We have identified a number of such trials which are taking place across multiple geographies. For each specific trial, we have provided the following information:
1. Trial Objective
2. Manufacturer / Licensee
3. Treatment Target
4. Mechanism of Action
5. Sponsor / Collaborator
6. Trial Phase
7. Trial Status
8. Start Date
9. End Date
10. Enrolment
11. Age Group
12. Inclusion Criteria
13. Exclusion Criteria
14. Study Design
15. Primary Endpoint
16. Secondary Endpoint
17. Treatment Arms
18. Route of Administration
19. Location(s)
20. Trial Results (if known)

The above information has also been presented in the form of a dashboard to provide a high level quick overview of the ongoing activity in this space.

RESEARCH METHODOLOGY

Most of the data presented in this report has been gathered by secondary research. The sources of information include:
- Company websites
- Annual reports
- Investor presentations
- SEC filings
- Industry databases
- News releases
- Government policy documents

Table Of Contents

Dry Eye Syndrome: Clinical Trial Tracker
TABLE OF CONTENTS
1. Market Overview
2. Dashboard: Pipeline Analysis
3. Molecules in Clinical Development: Trial Details
4. Molecules in Preclinical Development: Trial Details
5. Excluded Drugs
6. Inclusion / Exclusion Criteria

LIST OF FIGURES

Figure 1: Molecules in Clinical Development: Distribution by Companies
Figure 2: Molecules in Clinical Development: Distribution by Highest Phase of Development
Figure 3: Molecules in Clinical Development: Distribution by Treatment Target
Figure 4: Clinical Trials: Distribution by Trial Phase and Status (Matrix View)
Figure 5: Clinical Trials: Distribution by Trial Status
Figure 6: Clinical Trials: Distribution by Trial Phase
Figure 7: Clinical Trials: Distribution by Route of Administration
Figure 8: Clinical Trials: Distribution by Sponsor Type
Figure 9: Clinical Trials: Distribution by Region
Figure 10A: Clinical Trials: Distribution by Molecules and Regions (Matrix View) - Set 1
Figure 10B: Clinical Trials: Distribution by Molecules and Regions (Matrix View) - Set 2
Figure 10C: Clinical Trials: Distribution by Molecules and Regions (Matrix View) - Set 3
Figure 11: Clinical Trials: Distribution by G7 Countries
Figure 12: Clinical Trials: Distribution by EU5 Countries

LIST OF TABLES

Table 1: Molecules in Clinical Development: Pipeline Details
Table 2: Molecules in Preclinical Development: Pipeline Details


Companies Mentioned

1. Acucela
2. Alacrity Biosciences
3. Alcon Research
4. Allergan
5. Amgen
6. Astellas Pharma
7. Azienda Ospedaliera S. Maria della Misericordia
8. Bausch and Lomb
9. Bristol Eye Hospital
10. Bristol-Myers Squibb
11. BTO Pharm Co Ltd
12. C.T. Development America, Inc.
13. Can-Fite BioPharma
14. Chulalongkorn University
15. Cross Research S.A.
16. Daiichi Pharmaceuticals
17. Denver Arthritis Clinic
18. DH Bio Co., Ltd.
19. Dompe S.p.A
20. Dong-A Pharmaceutical Co., Ltd.
21. Ehime University
22. Eisai Inc.
23. Eleven Biotherapeutics
24. ESBATech AG
25. Eye and ENT Hospital of Fudan University
26. Eyegate Pharmaceuticals, Inc.
27. Federal University of Rio de Janeiro
28. Florida Eye Microsurgical Institute
29. Formulario MAgistral Farmacias Ahumada
30. Genentech
31. GlaxoSmithKline
32. Hanlim Pharm. Co., Ltd.
33. Hiroshima University
34. Hoffmann-La Roche
35. Hospital General Universitari Vall d'Hebron
36. Human Genome Sciences Inc.
37. I.M. Sechenov First Moscow State Medical University (MSMU)
38. Innovative Medical
39. InSite Vision
40. Inspire Pharmaceuticals
41. Instituto Universitario de Oftalmobiología Aplicada
42. Kanazawa Medical University
43. Keio University School of Medicine
44. Kissei Pharmaceutical Co., Ltd.
45. Kresge Eye Institute
46. KTandG Life Sciences Corp
47. Kyoto Prefectural University of Medicine
48. Laurantis Pharma
49. Lee's Pharmaceuticals (China, Taiwan)
50. Lux Biosciences, Inc.
51. Macusight
52. Mahidol University
53. Massachusetts Eye and Ear Infirmary
54. Medical University of South Carolina
55. Merck
56. MGI Pharma
57. Michigan Cornea Consultants, PC
58. Mimetogen Pharmaceuticals USA, Inc.
59. Minamiaoyama Eye Clinic
60. Mitotech, SA
61. Nagasaki University Graduate School of Biomedical Sciences
62. Nascent Pharmaceuticals
63. National Eye Institute (NEI)
64. National Institute of Allergy and Infectious Diseases (NIAID)
65. National Institute of Dental and Craniofacial Research (NIDCR)
66. National Institutes of Health Clinical Center (CC)
67. Nihon University School of Medicine
68. Nippon Medical School
69. Novagali Pharma
70. Novartis
71. Ophthalmic Consultants of Long Island
72. OpthaliX
73. Ora Inc.
74. Osaka University Hospital
75. Otsuka Pharmaceutical Co., Ltd.
76. Pfizer
77. Pontificia Universidad Catolica de Chile
78. RegeneRx Biopharmaceuticals, Inc.
79. Resolvyx Pharmaceuticals, Inc
80. Rhodes Pharmaceuticals L.P.
81. Rigel Pharmaceuticals
82. Roche
83. R-Tech Ueno, Ltd.
84. Rush Medical College
85. Santarus, Inc.
86. Santen Inc.
87. Santen Pharmaceutical Co., Ltd.
88. Santen SAS (previously Novagali Pharma)
89. SARcode Bioscience
90. Seikagaku Corporation
91. Shire Pharmaceuticals
92. SIFI Pharma
93. Sirion Therapeutics
94. South Arizona VA Healthcare System
95. Sun Yat-sen University
96. Sylentis, S.A.
97. Teika
98. The Catholic University of Korea
99. The Helmholtz Moscow Research Institute of Eye Diseases
100. Tokai University School of Medicine
101. Tokushima University Hospital
102. Tokyo Dental College Ichikawa General Hospital
103. Tokyo Electric Power Hospital
104. Tufts University Dental School
105. University Hospital, Brest
106. University Hospital, Strasbourg, France
107. University Medical Centre Groningen
108. University of Alabama at Birmingham
109. University of Ioannina, Greece
110. University of Kitasato School of Medicine
111. University of Miami
112. University of Michigan
113. University of Missouri-Columbia
114. University of Pittsburgh School of Medicine
115. University of Sao Paulo General Hospital
116. University of Udine
117. Valeant Pharmaceuticals
118. Winston Laboratories

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