Ophthalmological Therapeutics Pipelines, Delivery Technologies, and Markets

Ophthalmological Therapeutics Pipelines, Delivery Technologies, and Markets

Chapter 1
A BRIEF INTRODUCTION TO OPHTHALMOLOGY AND ITS MARKETS
1.1. The Eye and Its Disorders
1.2. The Ophthalmology Market
1.3. High Unmet Medical Need and Scientific Challenges

Chapter 2
THE HUMAN EYE: A UNIQUE THERAPEUTIC TARGET
2.1. Anatomy of the Visual Apparatus
2.2. Characterizing and Quantifying Vision
2.3. Eye Surgery
Surgery for the Inner Eye
Surgical Correction of Opacification or Refractive Deviations
2.4. Ophthalmological Drug Delivery: Barriers and Strategies

Chapter 3
DISORDERS OF THE ANTERIOR EYE: WHAT YOU CAN SEE IS NOT ALWAYS EASY TO TREAT
3.1. Dry Eye Syndrome
Existing Products for Dry Eye
Restasis
Advanced-Stage Investigational Drugs for Dry Eye
Early Experimental Therapeutic and Diagnostic Approaches to Dry Eye
3.2. Allergic Conjunctivitis
New Developments
3.3. Corneal Lesions and Dystrophy
3.4. Superficial Eye Infections
Infectious Conjunctivitis and Other "Simple" Anterior Eye Infections
AzaSite: The First Ophthalmic Azithromycin
Antibiotic and Combination Products in Development
3.5. Tropical Eye Infections Make Inroads
Atypical Keratitis: A Growing Problem in Temperate Climate Zones
Trachoma: The World's Leading Cause of Preventable Blindness
River Blindness
3.6. Cataracts: Aging and Denaturation of the Lens
A Sector Dominated by Surgery
An Uphill Struggle for Drug Development
Pharmacoprevention for Posterior Capsule Opacification
Lens Regeneration and Tissue Biotechnology
3.7. Glaucoma: Pressure in the Front, Neurodegeneration in the Back of the Eye
Drugs for Intraocular Pressure Reduction
The Current Drug Landscape for Glaucoma
New Developments in the Glaucoma Drug Field

Chapter 4
DISORDERS OF THE POSTERIOR EYE: AT THE SITE OF VISION
4.1. Vitrectomy: Radical Back-Eye Surgery for Multiple Causes
Vitreous Replacements
Preventing Formation of Cataracts as a Complication of Vitrectomy
Vitrase/Vitragan: A Potential Alternative to Vitrectomy for Hemorrhages
4.2. Diabetic Retinopathy and Retinal Vein Occlusion: A Lifestyle Disorder That Blinds
Laser Photocoagulation
Triamcinolone: Not Approved, but Widely Used, for DME
Ruboxistaurin: A Troubled Oral Drug Candidate for DME
More Experimental Drug Candidates for Retinopathy: The New and the Old
4.3. Age-Related Macular Degeneration: The Leading Cause of Blindness in the Industrialized World
Blood Vessel Sensitization to Phototherapy in Wet AMD
Visudyne: The Pioneer
Photrex and Optrin: 2 Follow-Up Photosensitizers
Biotechnology Anti-VEGF Products: Rise of a Class
Macugen
Lucentis
Avastin: Off-Label Use in AMD and the Supply Restrictions Controversy
Follow-Up Developments in Ocular VEGF Control
Beyond VEGF: A Failure, and Many Hopes
Noninvasive Clinical Product Developments for AMD
Vigorous Preclinical and Patenting Activity Indicates More Approaches Under Way
4.4. Retinitis Pigmentosa: The Most Frequent Inherited Eye Disease
4.5. Intraocular Melanoma and Retinoblastoma: Posterior Eye Oncology
Choroidal Melanoma
Retinoblastoma

Chapter 5
SIZE, STRUCTURE, AND DYNAMICS OF THE OPHTHALMOLOGICAL PHARMACEUTICAL MARKET
5.1. Small Innovators, Large Marketers
Alcon Laboratories
Allergan
Bausch & Lomb
Senju Pharmaceutical
Fovea Pharmaceuticals
ISTA Pharmaceuticals
MacuSight
Novagali Pharma
Ocularis Pharma
OSI Eyetech
OPKO Health
Othera Pharmaceuticals
Sirion Therapeutics
5.2. A Habitat for Specialized CROs
Iris Pharma and Clirophtha
PharmaNet Ophthalmology Group
Rx Development Resources
Global Clinical Trials Ophthalmology Research Services
5.3. Ophthalmological Market Dynamics and its Drivers
Demographics
Lifestyle
Capital Flows into the Ophthalmological Drug Development Market
5.4. Modeling the Ophthalmological Drug Market: Perspectives for 2015-2020

Chapter 6
EXPERT INTERVIEWS: A VIRTUAL ROUNDTABLE
Cedric Francois, MD, PhD
President and CEO
Potentia Pharmaceuticals, Louisville, KY
Avner Ingerman, MD
Vice President and Ophthalmology Team Leader
Regeneron Pharmaceuticals, Tarrytown, NY
Samuel Reich
Executive Vice President of Ophthalmologics
OPKO Health
Miami, FL
Roger Vogel, MD
Cofounder and Chief Medical Officer
Sirion Therapeutics, Tampa, FL
REFERENCES
COMPANY INDEX WITH WEB ADDRESSES

Tables

Table 3.1. Selected Artificial Tear Products Marketed in the United States and Europe

Table 3.2. Advanced Drug Candidates for Dry Eye Syndrome

Table 3.3. Antihistamines and Steroids for Topical Ocular Use in Allergic Conjunctivitis

Table 3.4. Newer Drugs for Intraocular Pressure Reduction Currently Used in the United States

Table 4.1. Sales and Revenue Figures for Visudyne and US Sales Share, 2000-2006

Table 4.2. Recent Patent Publications for Retinitis Pigmentosa

Table 5.1. Selected Alcon IP Documents Directed at Glaucoma and Published in 2006

Table 5.2. Allergan Net Sales for Selected Prescription OpHthalmology Drugs, 2002-2006

Table 5.3. Fovea Pharmaceuticals' Ophthalmological Drug Pipeline

Table 5.4. The Current US Prescription Ophthalmological Drug Market and its Projected Development Through 2015-2020

Figures

Figure 2.1. A Cross-Sectional Schematic of the Human Eye

Figure 3.1. Lens Transparency, Lens Aging, and Cataract Formation

Figure 3.2. Fluid Formation and Outflow Through the Trabecular Meshwork

Figure 4.1. Visual Acuity Changes in the US-European Phase III TAP Study Program for Visudyne