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Reportlinker Adds Ophthalmology DrugFutures
Date:4/21/2011

NEW YORK, April 21, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Ophthalmology DrugFutures

http://www.reportlinker.com/p0484753/Ophthalmology-DrugFutures .html

A complete and practical analysis of Ophthalmology Drugs packed with facts, figures and forecasts for launched and late-stage products

The US$14 billion global ophthalmology sector faces both commercial challenge and clinical opportunity, and this report answers key questions:

Why are we interested in chronic eye diseases?

Driven by ageing populations, which markets are expected to see the highest growth in the 65+ age groups?

Which sectors of the market are anticipated to contract by value over the next five years?

What new products will be launched over the next 5 years and what impact will they have on the market?

Which companies are set to improve their market share?

What novel products are in development for Wet Age-related Macular Degeneration (AMD)?

Dry AMD – large unmet clinical need, but what is the potential?

What potential benefits does Bayer's VEGF Trap?Eye Regeneron have over existing treatments?

Merck's NDA for Saflutan was submitted to FDA in March 2011 – what impact on the market could this product have?

Why are new treatments needed for dry eye?

Sight preservation in chronic eye disease is a high yielding, valuable and expanding sector in developed and emerging markets

AGE-RELATED MACULAR DEGENERATION

The market for drugs used to treat wet age-related macular degeneration (AMD) is estimated to be worth US$3.3 billion. There are relatively few players and an increasing patient pool; continued growth is expected over the medium term.

The current standard of care for wet AMD is Lucentis (ranibizumab), marketed by Roche in the US and Novartis elsewhere. Growth has been impressive since its launch in 2006; global sales amounted to US$3 billion in 2010. The cost of treatment is high, however, and there is some competition from off-label use of Roche's Avastin (bevacizumab), which is significantly cheaper. In the US, the National Eye Institute is conducting a major Phase III comparative study of Avastin and Lucentis for the treatment of AMD.

But there is new competition expected on the market. The most advanced developmental treatment for AMD is Bayer and Regeneron's VEGF Trap-Eye. Following positive top-line results from Phase III trials, regulatory filings have been planned in the US and EU in 2011. If approved, it is expected that this product will be quickly taken up in the market-place. It appears to have similar efficacy to Lucentis with less frequent dosing, which is likely to prove popular among patients and healthcare providers alike.

The report covers

Market analysis

What is macular degeneration?

How is it treated?

Photodynamic Therapy

Anti-VEGF

Why are new treatments needed?

What is in development?

AMD prevalence

Launched products

Lucentis (ranibizumab)

Macugen (pegaptanib)

Visudyne (verteporfin)

Phase III

VEGF Trap-Eye

Phase II

ACU-4429

PF-4523655

GLAUCOMA

Glaucoma affects around 65-70 million people worldwide and is the second leading cause of blindness, after cataracts. The WHO estimates that glaucoma was responsible for around 12.3% of world blindness in 2002, affecting around five million people.

Undoubtedly, generic companies will claim a significant share of the US$4.9 billion glaucoma market over the next few years. Pfizer's US patent for the market leader, Xalatan (latanoprost) expired in March 2011 and the first generics have been approved.

Others in this segment are also set to lose exclusivity over the next few years. Dependent on the outcome of patent litigation, Alcon's Travatan Z (travoprost) could face generic competition in the US as early as December 2011. Allergan's US patents for Lumigan (bimatoprost) will expire in 2012 and 2014, while the European patents are set to expire in various markets between 2013 and 2017.

In the short term, there may be new competition in the US if Merck & Co is successful in gaining approval for Saflutan (tafluprost). Merck & Co has a licensing agreement for the product with Santen Pharmaceutical who market it in some Asian/European markets. Beyond new formulations and combination products in Phase III, the most advanced novel agents have yet to progress beyond Phase II.

The report covers

Market analysis

What is glaucoma?

How is it treated?

Why are new treatments needed?

What is in development?

Glaucoma prevalence

Launched products

Alphagan (brimonidine)

Trusopt (dorzolamide)

Azopt (brinzolamide)

Xalatan (latanoprost)

Lumigan (bimatoprost)

Travatan (travoprost)

Saflutan (tafluprost)

Phase II

BOL-303259-X

AR-12286

Phase I/II

INO-8875

DRY EYE SYNDROME

Alongside glaucoma and AMD, dry eye is a growing problem and one that also increases with age. While this condition is widely treated with artificial tear products that are available over the counter, the prescription market is currently worth around US$1.5 billion.

There are relatively few prescription pharmaceuticals to treat more severe cases; in the US, Allergan's Restasis (ciclosporin) ophthalmic emulsion is currently the only product approved to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation. Competition may be on the horizon, however, from ISTA Pharmaceuticals' Remura (bromfenac), which is in Phase III for the condition.

The report covers

Market analysis

What is dry eye syndrome?

How is it treated?

Why are new treatments needed?

What is in development?

Dry eye prevalence

Launched products

Restasis (ciclosporin)

Hyalein (sodium hyaluronate)

Diquas (diquafosol)

New formulations in development

Remura (bromfenac)

Mucosta (rebamipide)

Phase II/III

CF101

Phase II

Tofacitinib

About the Author

The report has been researched and written by Espicom's Senior Analyst, Karen Holmes. Karen has over 15 years pharmaceutical and healthcare market analysis experience. Her recent studies include:

Injectable Generic Drugs: Prospects and Opportunities,

Emerging Opportunities in Inhalation and Nasal Spray Generic Drugs

Multiple Sclerosis: what the future holds

The Indian Pharmaceutical Industry

Table of Contents

FOREWORD ....... 1

EXECUTIVE SUMMARY .. 3

MARKET OVERVIEW ...... 5

RESEARCH & DEVELOPMENT SUMMARY ......... 10

COMPETITOR RATIO ANALYSIS .. 12

BACKGROUND INFORMATION ... 14

Eye Disease in an Ageing Population ........ 14

AGE-RELATED MACULAR DEGENERATION ... 18

MARKET ANALYSIS . 18

WHAT IS MACULAR DEGENERATION? .. 20

HOW IS IT TREATED?.......... 21

Photodynamic Therapy ...... 21

Anti-VEGF ........ 21

WHY ARE NEW TREATMENTS NEEDED? ........... 22

WHAT IS IN DEVELOPMENT? ....... 22

AMD PREVALENCE . 24

ESTABLISHED PRODUCTS 25

Lucentis (ranibizumab) .......... 25

Mode of Action .......... 25

Current Status 25

Proof of Concept/Clinical Data .... 25

Development Risks .. 27

Company Expertise .. 27

Competition within the Market .. 27

Competitor Ratio Analysis . 28

Sales Forecast 28

Clinical Trial Results . 29

Macugen (pegaptanib) .......... 35

Mode of Action .......... 35

Current Status 35

Proof of Concept/Clinical Data .... 35

Development Risks .. 37

Company Expertise .. 37

Competition within the Market .. 37

Competitor Ratio Analysis . 38

Clinical Trial Results . 38

Visudyne (verteporfin) ........... 40

Mode of Action ......... 40

Current Status ........... 40

Proof of Concept/Clinical Data.... 40

Development Risks .. 41

Company Expertise . 41

Competition within the Market .. 41

Competitor Ratio Analysis 41

Clinical Trial Results . 41

PHASE III ........ 45

VEGF Trap-Eye .. 45

Mode of Action ......... 45

Current Status ........... 45

Proof of Concept/Clinical Data.... 45

Development Risks .. 46

Company Expertise . 46

Competition within the Market .. 46

Competitor Ratio Analysis 46

Sales Forecast 47

Clinical Trial Results . 47

PHASE II ......... 51

ACU-4429 ........... 51

Mode of Action ......... 51

Current Status ........... 51

Proof of Concept/Clinical Data.... 51

Development Risks .. 51

Company Expertise . 52

Competition within the Market .. 52

Competitor Ratio Analysis 52

PF-4523655 ........ 53

Mode of Action ......... 53

Current Status ........... 53

Proof of Concept/Clinical Data.... 53

Development Risks .. 53

Company Expertise . 53

Competition within the Market .. 54

Competitor Ratio Analysis 54

GLAUCOMA ..... 55

MARKET ANALYSIS . 55

WHAT IS GLAUCOMA? ...... 56

HOW IS IT TREATED? ......... 58

Open-Angle Glaucoma and Ocular Hypertension ........ 58

Pharmacological Treatments ....... 58

Laser Treatment/Surgery ... 59

Angle-Closure Glaucoma ...... 59

Pharmacological Intervention ..... 59

Laser Treatment/Surgery ... 59

WHY ARE NEW TREATMENTS NEEDED? ........... 60

WHAT IS IN DEVELOPMENT? ....... 60

GLAUCOMA PREVALENCE ........... 62

ESTABLISHED PRODUCTS 63

Alphagan (brimonidine) ........ 63

Mode of Action .......... 63

Current Status 63

Proof of Concept/Clinical Data .... 63

Development Risks .. 64

Company Expertise .. 64

Competition within the Market .. 64

Competitor Ratio Analysis . 65

Sales Forecast 65

Trusopt (dorzolamide) ........... 67

Mode of Action .......... 67

Current Status 67

Proof of Concept/Clinical Data .... 67

Development Risks .. 67

Company Expertise .. 68

Competition within the Market .. 68

Competitor Ratio Analysis . 68

Sales Forecast 69

Azopt (brinzolamide) . 70

Mode of Action .......... 70

Current Status 70

Proof of Concept/Clinical Data .... 70

Development Risks .. 71

Company Expertise .. 71

Competition within the Market .. 71

Competitor Ratio Analysis . 71

Sales Forecast 72

Xalatan (latanoprost) .. 73

Mode of Action .......... 73

Current Status 73

Proof of Concept/Clinical Data .... 74

Development Risks .. 74

Company Expertise . 74

Competition within the Market .. 74

Competitor Ratio Analysis 75

Sales Forecast 75

Lumigan (bimatoprost) ......... 77

Mechanism of Action .......... 77

Current Status ........... 77

Proof of Concept/Clinical Data.... 77

Development Risks .. 78

Company Expertise . 78

Competition within the Market .. 78

Clinical Trial Results . 79

Competitor Ratio Analysis 80

Sales Forecast 81

Travatan (travoprost) . 82

Mode of Action ......... 82

Current Status ........... 82

Proof of Concept/Clinical Data.... 83

Development Risks .. 83

Company Expertise . 83

Competition within the Market .. 83

Competitor Ratio Analysis 84

Sales Forecast 85

Saflutan (tafluprost) .... 86

Mode of Action ......... 86

Current Status ........... 86

Proof of Concept/Clinical Data.... 86

Development Risks .. 87

Company Expertise . 87

Competition within the Market .. 87

Competitor Ratio Analysis 88

Sales Forecast 88

PHASE II ......... 89

Taprenepag ....... 89

Mode of Action ......... 89

Current Status ........... 89

Proof of Concept/Clinical Data.... 89

Development Risks .. 89

Company Expertise . 89

Competition within the Market .. 89

Competitor Ratio Analysis 90

Clinical Trial Results . 90

BOL-303259-X ... 92

Mode of Action .......... 92

Current Status 92

Proof of Concept/Clinical Data .... 92

Development Risks .. 92

Company Expertise .. 92

Competition within the Market .. 93

Competitor Ratio Analysis . 93

AR-12286 94

Mode of Action .......... 94

Current Status 94

Proof of Concept/Clinical Data .... 94

Development Risks .. 94

Company Expertise .. 94

Competition with the Market ...... 94

Competitor Ratio Analysis . 95

Clinical Trial Results . 95

PHASE I/II ....... 96

INO-8875 96

Mode of Action .......... 96

Current Status 96

Proof of Concept/Clinical Data .... 96

Development Risks .. 96

Company Expertise .. 96

Competition within the Market .. 96

Competitor Ratio Analysis . 97

DRY EYE SYNDROME ... 98

MARKET ANALYSIS . 98

WHAT IS DRY EYE SYNDROME? . 99

HOW IS IT TREATED?........ 100

WHY ARE NEW TREATMENTS NEEDED? ......... 100

WHAT IS IN DEVELOPMENT? ..... 100

DRY EYE PREVALENCE..... 101

LAUNCHED PRODUCTS .. 102

Restasis (ciclosporin) 102

Mode of Action ....... 102

Current Status ......... 102

Proof of Concept/Clinical Data . 102

Development Risks ........... 102

Company Expertise ........... 103

Competition within the Market 103

Competitor Ratio Analysis .......... 103

Sales Forecast .......... 104

Hyalein (sodium hyaluronate) ....... 105

Mode of Action ....... 105

Current Status ......... 105

Proof of Concept/Clinical Data.. 105

Development Risks 105

Company Expertise ........... 105

Competition within the Market 105

Competitor Ratio Analysis .......... 106

Sales Forecast .......... 106

Diquas (diquafosol) .. 107

Mode of Action ....... 107

Current Status ......... 107

Proof of Concept/Clinical Data.. 107

Development Risks 107

Company Expertise ........... 108

Competition within the Market 108

Competitor Ratio Analysis .......... 108

NEW FORMULATIONS IN DEVELOPMENT ..... 109

Remura (bromfenac) 109

Mode of Action ....... 109

Current Status ......... 109

Proof of Concept/Clinical Data.. 109

Development Risks 109

Company Expertise ........... 110

Competition with the Market .... 110

Competitor Ratio Analysis .......... 110

Clinical Trial Results ........... 110

Mucosta (rebamipide) ......... 111

Mode of Action ....... 111

Current Status ......... 111

Proof of Concept/Clinical Data.. 111

Development Risks 111

Company Expertise ........... 111

Competition within the Market 112

Competitor Ratio Analysis .......... 112

PHASE II/III .. 113

CF101 ..... 113

Mode of Action ....... 113

Current Status ......... 113

Proof of Concept/Clinical Data . 113

Development Risks ........... 113

Company Expertise ........... 113

Competition within the Market ........... 113

Competitor Ratio Analysis .......... 114

Clinical Trial Results .......... 114

PHASE II ....... 115

Tofacitinib ........ 115

Mode of Action ....... 115

Current Status ......... 115

Proof of Concept/Clinical Data . 115

Development Risks ........... 115

Company Expertise ........... 115

Competition within the Market ........... 115

Competitor Ratio Analysis .......... 116

METHODOLOGY ....... 117

Competitor Ratio Analysis Criteria ...... 117

Drug Sales Forecasting .... 117


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SOURCE S ....... 118
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