ORPHAN DISEASE SERIES - Glaucoma: Can Orphan-Drug Status Offer an Entry into a Mature Market?

Published by: Decision Resources

Published: Jun. 11, 2008 - 38 Pages

Table of Contents

Executive Summary

Strategic Considerations

Stakeholder Implications

Introduction

Overview of Glaucoma

Anatomy of the Eye

Types of Glaucoma

Risk Factors for Glaucoma

Diagnosis, Disease Progression, and Prognosis

Epidemiology

Current Drug Treatments for Glaucoma

Beta Blockers

Prostaglandin F2 Analogues

Carbonic Anhydrase Inhibitors

Alpha 2-Adrenoreceptor Agonists

Combination Agents

Emerging Treatments for Glaucoma

Alcon’s Anecortave Acetate

QLT’s Latanoprost Punctal-Plug Delivery System

Santen/UBE Industries’ DE-104

Glaucoma as an Orphan Indication

2007 Glaucoma Market and Market Outlook

2007 Market

Outlook for Existing and Emerging Agents

About the Authors

Appendix A. Incentive Programs for the Research, Development, and Marketing of Orphan Drugs

FDA

Expanded Market Exclusivity

Tax Credits

Support During the Drug Approval Process

Grants

EMEA

Private Organization Incentives

Appendix B. Epidemiology Methods

Appendix C. Bibliography

Appendix D. Thought Leaders Interviewed for This Report—Glaucoma

Tables

1. Select Types of Glaucoma

2. Risk Factors for Developing Glaucoma

3. Current Therapies to Treat Glaucoma, 2008

4. Select Surgeries Used to Treat Open-Angle Glaucoma

5. Emerging Therapies for the Treatment of Glaucoma

6. Sales of Select Agents to Treat Glaucoma and Ocular Hypertension

B1. Number of Total Prevalent Cases of Primary Open-Angle Glaucoma by Age and Gender in the United States, 2007-2017

B2. Number of Total Prevalent Cases of Congenital Glaucoma by Gender in the United States, 2007-2017

Figures

1. Diagram of the Eye

2. Age and Gender Distribution of Total Primary Open-Angle Glaucoma Prevalence per 1,000 in the United States, 2007

3. Number of Total Prevalent Cases of Congenital Glaucoma by Gender in the United States, 2007-2017

4. Sales Growth of the U.S. Glaucoma Market, 2000-2007

5. Patient Share of Glaucoma Drug Classes, 2000-2007

6. Company Share of the Glaucoma Market, 2007

A1. Number of Drugs Receiving FDA Orphan-Drug Designation and Approval, 1983-2007

A2. Growth in the Number of Orphan Drugs Available, 1983-2007

Abstract

• Various forms of glaucoma affect more than 50 million people in the United States; the majority are treated with agents to lower intraocular pressure. What unmet needs exist that could provide entry for novel agents? What agents are currently in development? What do thought leaders say they would like to see in an emerging treatment?
• Ophthalmologists interviewed say that compliance is one of the biggest issues in the successful treatment of glaucoma. What do these thought leaders say about their prescribing preferences related to dosing regimens? What novel agents are in development to test new delivery methods and new formulations?
• Several companies are developing agents to improve existing therapy options. What early clinical data have been released regarding these studies? How do thought leaders view the potential of these emerging drugs?
• A recent search of the National Institute of Health’s Office of Rare Diseases revealed more than 20 orphan conditions that include glaucoma as a relevant symptom. What indications would benefit from orphan-drug discovery? Which agents have already received orphan-drug designation for glaucoma treatment?

• Current treatments for glaucoma : beta blockers; prostaglandin F2 analogues; carbonic anhydrase inhibitors; alpha 2-adrenoreceptor agonists; combination agents.
• Epidemiology : prevalent cases of primary open-angle and congenital glaucoma (CG); expected growth through 2017.
• Overview of glaucoma: anatomy of the eye; types of glaucoma; risk factors for glaucoma; diagnosis, disease progression, prognosis.
• Emerging treatments for glaucoma: Alcon’s anecortave acetate; QLT’s latanoprost punctal-plug delivery system; Santen/UBE Industries’ DE-104.
• Glaucoma as an orphan indication : neovascular glaucoma; juvenile primary open-angle glaucoma.
• Glaucoma market outlook : decline in market due to patent expiry and lack of new branded agents; emerging agents with improved side-effect profiles and delivery mechanisms more likely to see significant uptake.
• Orphan Disease Series: As competition increases in larger disease states, companies are turning to orphan diseases that offer substantial pricing advantages and lower regulatory hurdles because of high unmet need. The Orphan Disease Series provides critical market information, including disease prevalence, profiles of marketed and emerging agents, and insight into the prescribing choices of disease specialists for diseases with smaller patient populations. These reports will help you to maximize the potential of your agents in these challenging markets, including the regulatory benefits available and the potential for partnership with charitable organizations.

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