2. www.visiongain.com
Contents
1.1 Global Ophthalmic Drugs: Market Overview
1.2 Global Ophthalmic Drugs Market Segmentation
1.3 Why You Should Read This Report
1.4 How This Report Delivers
1.5 Key Questions Answered By This Analytical Report
1.6 Who Is This Report For?
1.7 Methodology
1.8 Frequently Asked Questions (FAQ)
1.9 Associated Reports
1.10 About Visiongain
2.1 The Pharmaceutical Industry: A Brief Introduction
2.1.1 Ophthalmic Treatments – An Industry Overview
2.2 The Human Eyes – Structurally Delicate And Functionally Intricate Organs
2.3 The Global Burden Of Eye Disease
2.4 Ophthalmic Drugs: Market Segmentation
2.5 Glaucoma: A Major Cause Of Vision Loss
2.5.1 A Classification Of Glaucoma
2.5.1.1 Primary Open-Angle Glaucoma
2.5.1.2 Acute Angle-Closure Glaucoma
2.5.1.3 Congenital Glaucoma
2.5.1.4 Secondary Glaucoma
2.5.1.5 Normal-Tension Glaucoma
2.5.1.6 Ocular Hypertension
2.5.2 Risk Factors For Glaucoma
2.5.3 Diagnosis Of Glaucoma
1. Report Overview
2. An Introduction To Ophthalmic Drugs
3. www.visiongain.com
Contents
2.5.4 Drug Treatment Of Glaucoma
2.5.5 Laser Treatment And Surgery For Glaucoma
2.6 Age-Related Macular Degeneration (AMD)
2.6.1 Dry (non-exudative) AMD
2.6.2 Wet (exudative) AMD
2.6.3 Risk Factors For AMD
2.6.4 Diagnosis of AMD
2.6.5 Treatment of AMD
2.7 Diabetic Retinopathy (DR)
2.7.1 Diagnosis Of Diabetic Retinopathy
2.7.2 Treatment Of Diabetic Retinopathy
2.8 Ocular Allergy And Allergic Conjunctivitis
2.8.1 Diagnosis Of Ocular Allergy
2.8.2 Treatment Of Ocular Allergy
2.9 Ocular Inflammatory Disease
2.9.1 Treatment Of Ocular Inflammatory Disease
2.10 Eye Infections
2.10.1 Treatment Of Eye Infections
2.11 Dry Eye Syndrome
2.11.1 Treatment of Dry Eye Syndrome
2.12 Phases of Clinical Trials
2.13 Ophthalmic Drugs: Market Definition In This Report
3.1 The Global Ophthalmic Drugs Market: Market Overview
3.2 Categorisation Of The Global Ophthalmic Drugs Market
3.3 The Global Ophthalmic Drugs Market In 2014
3.4 The Global Ophthalmic Drugs Market: Market Forecast 2015-2025
3.5 Ophthalmic Drugs: Changing Market Shares By Sector 2015-2025
3. The Global Ophthalmic Drugs Market, 2015-2025
4. www.visiongain.com
Contents
4.1 Leading Products In The Retinal Disorder Drugs Market, 2014
4.2 Retinal Disorders: Market Trends And Developments, 2015
4.2.1 The Rise And Rise Of Lucentis
4.2.2 The Debate Around Off-Label Avastin Use And The Role Of Novartis And Roche
4.2.3 How Likely Is Avastin’s Expansion Into Age-Related Macular Degeneration?
4.2.4 Jetrea: Underwhelming Sales And ThromboGenics’ Efforts To Reverse It
4.2.5 Drug/Device Combination Products Entering The Market
4.2.6 Does Regenerative Medicine Have A Successful Future In Ophthalmics?
4.3 Retinal Disorder Drugs: Market Forecast 2015-2025
4.3.1 Retinal Disorder Drugs: Changing Market Shares By Leading Drugs 2015-2025
4.4 Leading Drugs For The Treatment Of Retinal Disorders
4.5 Lucentis (ranibizumab) – Roche/ Novartis
4.5.1 Lucentis: Sales Forecast 2015-2025
4.5.2 Less Frequent Dosing Approved In US For Lucentis
4.5.3 New Indications For Lucentis
4.5.4 Possible Combination Therapy Involving Lucentis
4.6 Eylea (aflibercept) - Regeneron/ Bayer/ Santen
4.6.1 Recent Approvals For Eylea
4.6.2 Eylea: Sales Forecast 2015-2025
4.6.3 Possible Combination Therapies Involving Eylea
4.7 Avastin (bevacizumab) - Roche
4.7.1 Avastin: Sales Forecast 2015-2025
4.7.2 Compounding Pharmacies And Safety Risks
4.8 Visudyne (verteporfin) - Valeant/ Novartis
4.8.1 Visudyne: Sales Forecast 2015-2025
4.9 Jetrea (ocriplasmin) - ThromboGenics/ Novartis
4. The Retinal Disorder Drugs Market: Market Analysis And Forecast
2015-2025
5. www.visiongain.com
Contents
4.9.1 Jetrea: Recent Sales Performance
4.9.2 Clinical Study Plans For Jetrea
4.9.3 Jetrea: Sales Forecast 2015-2025
4.9.4 Possible Acquisition Move On ThromboGenics
4.9.5 R&D Agreements With Eleven Biotherapeutics and Bicycle Therapeutics
4.10 Other Retinal Disorder Drugs
4.10.1 Iluvien (fluocinolone implant) - Alimera Sciences
4.10.2 Ozurdex (dexamethasone implant) - Allergan
4.10.3 Other Retinal Disorder Drugs: Sales Forecast 2015-2025
5.1 Leading Products In The Allergic, Inflammatory And Infective Drugs Market, 2014
5.1.1 Allergic, Inflammatory And Infective Drugs: Market Trends And Developments, 2015
5.1.2 The Growth Prospects For Allergic, Inflammatory And Infective Drugs
5.1.3 Topical NSAIDs Launched: Prolensa and Ilevro
5.2 Allergic, Inflammatory And Infective Drugs: Market Forecast 2015-2025
5.2.1 Allergic, Inflammatory And Infective Drugs: Changing Market Shares By Leading
Drugs 2015-2025
5.3 Leading Drugs For The Treatment Of Allergic, Inflammatory And Infective Ophthalmic
Conditions
5.4 Patanol And Pataday (olopatadine) - Alcon (Novartis)
5.4.1 Pataday: Sales Forecast 2015-2025
5.4.2 Impending Generic Competition For Patanol And Pataday
5.4.3 Approval Of Pazeo Solution
5.4.4 Patanol: Sales Forecast 2015-2025
5.5 Vigamox (moxifloxacin) – Alcon (Novartis)
5.5.1 Intensifying Competition And Generics Drug Challenge To Vigamox
5.5.2 Moxeza: A Next-Generation Form of Vigamox
5. Allergic, Inflammatory & Infective Drugs Market: Market Analysis
And Forecast 2015-2025
6. www.visiongain.com
Contents
5.5.3 Vigamox: Sales Forecast 2015-2025
5.6 TobraDex (tobramycin/dexamethasone) – Alcon (Novartis)
5.6.1 The Development And Commercialisation Of TobraDex ST
5.6.2 TobraDex: Sales Forecast 2015-2025
5.7 Bromday (bromfenac) - Valeant
5.7.1 Prolensa: A New Formulation Of Bromfenac
5.7.2 Competition From Ilevro/Nevanac
5.7.3 Bromday: Sales Forecast 2015-2025
5.8 Cravit (levofloxacin) - Santen
5.8.1 Cravit: Sales Forecast 2015-2025
5.9 Acular (ketorolac) – Allergan (Actavis)
5.9.1 Acular: Sales Forecast 2015-2025
5.10 AzaSite (azithromycin) - Akorn
5.10.1 AzaSite: Sales Forecast 2015-2025
5.11 Other Allergic, Inflammatory, And Infective Drugs: Sales Forecast 2015-2025
6.1 Glaucoma Drugs: Market Overview
6.1.1 Leading Products In The Glaucoma Drugs Market, 2014
6.2 Glaucoma Drugs: Market Trends And Developments, 2015
6.2.1 Patent Expiration: A Major Restraint For Glaucoma Drugs
6.2.2 Preservative-Free Formulation Trends
6.2.3 Innovation In Treatments For Glaucoma
6.2.4 Simbrinza: First Beta-Blocker-Free Combination
6.3 Glaucoma Drugs: Market Forecast 2015-2025
6.3.1 Glaucoma Drugs: Changing Market Shares By Leading Drugs 2015-2025
6.4 Leading Drugs For The Treatment Of Glaucoma
6.5 Lumigan And Ganfort (bimatoprost) – Allergan (Actavis)
6.5.1 Lumigan And Ganfort: Sales Forecast 2015-2025
6. Glaucoma Drugs Market: Market Analysis And Forecast 2015-
7. www.visiongain.com
Contents
6.6 Xalatan And Xalacom (latanoprost) - Pfizer
6.6.1 Xalatan/Xalacom: Sales Forecast 2015-2025
6.7 Travatan/Travatan Z And DuoTrav (travoprost) - Novartis
6.7.1 Travatan/Travatan Z And DuoTrav: Sales Forecast 2015-2025
6.8 Alphagan/Alphagan P And Combigan (brimonidine) - Allergan
6.8.1 Alphagan/Alphagan P And Combigan: Sales Forecast 2015-2025
6.9 Trusopt And Cosopt/Cosopt PF (dorzolamide) – Merck/ Santen
6.9.1 Divestment Agreement With Santen And Akorn
6.9.2 Trusopt: Sales Forecast 2015-2025
6.9.3 Cosopt And Cosopt PF: Sales Forecast 2015-2025
6.10 Azopt (brinzolamide) - Novartis
6.10.1 Azopt: Sales Forecast 2015-2025
6.11 Tapros (tafluprost) – Santen
6.11.1 Tapros: Sales Forecast 2015-2025
6.12 Zioptan (tafluprost) - Akorn
6.12.1 Zioptan: Sales Forecast 2015-2025
6.13 Other Glaucoma Drugs: Sales Forecast 2015-2025
7.1 Dry Eye Drugs: Market Overview
7.1.1 Leading Products In The Dry Eye Drugs Market, 2014
7.2 Dry Eye Drugs: Market Trends And Developments, 2015
7.2.1 Restasis: Patent Elongations And Generic Challenges Creating Uncertainty
7.2.2 Intensifying Research Focused On Dry Eye
7.2.3 Improving Diagnostic Tools
7.3 Dry Eye Drugs: Market Forecast 2015-2025
7.3.1 Dry Eye Drugs: Changing Market Shares By Leading Drugs 2015-2025
7.4 Leading Drugs For The Treatment Of Dry Eye
7.5 Restasis (ciclosporin) – Allergan (Actavis)
7. Dry Eye Drugs Market: Market Analysis And Forecast 2015-2025
8. www.visiongain.com
Contents
7.5.1 Restasis Patent Elongation
7.5.2 Restasis: Sales Forecast 2015-2025
7.6 Refresh Brand Products – Allergan (Actavis)
7.6.1 Refresh Brand Products: Sales Forecast 2015-2025
7.7 Hyalein (hyaluronic acid) - Santen
7.7.1 Hyalein: Sales Forecast 2015-2025
7.8 Diquas (diaquafosol) - Santen
7.8.1 Diquas: Sales Forecast 2015-2025
7.9 Other Dry Eye Drugs: Sales Forecast 2015-2025
7.10 Other Ophthalmic Drugs
7.10.1 Hetlioz (tasimelteon) - Vanda Pharmaceuticals
7.10.1.1 Hetlioz: Sales Forecast 2015-2025
8.1 The Ophthalmic Drugs Market By Region
8.1.1 The Global Distribution Of Ophthalmic Drugs In 2014
8.2 Leading National Markets: Forecast 2015-2025
8.2.1 Changing Market Shares By Region, 2015-2025
8.3 Regional Ophthalmic Drugs Markets: Analysis And Forecasts, 2015-2025
8.4 United States: The Largest Ophthalmic Drugs Market
8.4.1 How Will The Rise Of A Biosimilars Market Impact On US Ophthalmic Drugs?
8.4.2 US Ophthalmic Drugs Market: Market Forecast 2015-2025
8.5 EU5
8.5.1 EU5 Ophthalmic Drugs Market: Market Forecast 2015-2025
8.5.1.1 EU5 Markets: Changing Market Shares By Country, 2015-2025
8.5.2 Germany
8.5.2.1 German Ophthalmic Drugs Market: Market Forecast 2015-2025
8.5.3 France
8.5.3.1 French Ophthalmic Drugs Market: Market Forecast 2015-2025
8. Leading National Markets For Ophthalmic Drugs, 2015-2025
9. www.visiongain.com
Contents
8.5.4 UK
8.5.4.1 UK Ophthalmic Drugs Market: Market Forecast 2015-2025
8.5.5 Italy
8.5.5.1 Italian Ophthalmic Drugs Market: Market Forecast 2015-2025
8.5.6 Spain
8.5.6.1 Spanish Ophthalmic Drugs Market: Market Forecast 2015-2025
8.6 Japan
8.6.1 The Cost Of Treatment In Japan
8.6.2 Japanese Pharmaceutical Industry Regulatory Reform
8.6.3 Japanese Ophthalmic Drugs Market Forecast 2015-2025
8.7 China
8.7.1 Expansion Of Healthcare Coverage And Reimbursement In China
8.7.2 Price Controls And The Anhui Model
8.7.3 Chinese Ophthalmic Drugs Market: Market Forecast 2015-2025
8.8 Brazil
8.8.1 How Will Brazil’s Growing Healthcare Influence Ophthalmic Drugs
8.8.2 Brazilian Ophthalmic Drugs Market: Market Forecast 2015-2025
8.9 Russia
8.9.1 How Will Russia’s Economic Status Affect Its Pharma Industry?
8.9.2 Russian Ophthalmic Drugs Market: Market Forecast 2015-2025
8.10 India
8.10.1 The Impact Of The Drug Prices Control Order On Indian Pharma
8.10.2 India’s Expansion Of Healthcare Provision
8.10.3 Indian Ophthalmic Drugs Market: Market Forecast 2015-2025
8.11 Mexico
8.11.1 Mexican Healthcare Reform: Introducing Seguro Popular
8.11.2 Are Multinationals Waking Up To Mexico’s Market Potential?
8.11.3 Mexican Ophthalmic Drugs Market: Market Forecast 2015-2025
8.12 Rest of the World
8.12.1 Rest of the World Ophthalmic Drugs Market: Market Forecast 2015-2025
10. www.visiongain.com
Contents
9.1 Ophthalmic Drugs – A Changing Market Landscape
9.1.1 Leading Companies In The Ophthalmic Drugs Market, 2015
9.1.2 Ophthalmic Drugs Market: Leading Companies Forecast 2015-2025
9.1.3 Ophthalmic Drugs: Changing Market Shares By Leading Companies 2015-2025
9.2 Novartis (Alcon)
9.2.1 Novartis: Ophthalmic Drugs Portfolio, 2015
9.2.2 Novartis: Sales Forecast 2015-2025
9.2.3 Novartis: Ophthalmic Drugs Development Pipeline, 2015
9.2.4 Novartis: Recent Developments
9.2.4.1 Novartis Restructures Following Strategic Review
9.2.4.2 Novartis Licenses Ophthotech’s Fovista
9.3 Allergan (Actavis)
9.3.1 Allergan: Ophthalmic Drugs Portfolio
9.3.2 Allergan: Recent Developments
9.3.2.1 Ozurdex (Dexamethasone Intravitreal Implant): The First Drug Therapy for
Diabetic Macular Oedema
9.3.2.2 How Real Is The Threat Of Generic Restasis?
9.3.2.3 Valeant’s Attempted Takeover Squashed By Actavis Bid
9.3.3 Allergan: Sales Forecast 2015-2025
9.3.4 Allergan: Ophthalmic Drugs Development Pipeline, 2015
9.4 Roche
9.4.1 Roche: Ophthalmic Drugs Portfolio, 2015
9.4.1.1 Lucentis: US Sales Forecast 2015-2025
9.4.2 Roche: Sales Forecast 2015-2025
9.4.3 Roche: Ophthalmic Drugs Development Pipeline, 2015
9.5 Santen
9.5.1 Santen: Ophthalmic Drugs Portfolio, 2015
9. Leading Companies In The Ophthalmic Drugs Market, 2015-2025
14. www.visiongain.com
Contents
10.3.2.3 NVC-422 (auriclosene) - NovaBay
10.3.2.4 Sarilumab - Regeneron
10.3.2.5 V404 PDS - ForSight VISION
10.3.3 Drugs In Phase 1 And Pre-clinical Development For Allergic, Inflammatory and
Infective Ophthalmic Conditions
10.3.3.1 Finafloxacin - MerLion Pharmaceuticals/Novartis
10.4 Drugs For Glaucoma: Development Pipeline, 2015
10.4.1 Drugs In Phase 2&3 Development For Glaucoma
10.4.1.1 Latanoprostene Bunod (VESNEO; BOL 303259-X) - Valeant
10.4.1.2 AMA0076 (ROCK inhibitor) - Amakem
10.4.1.3 Rhopressa (AR-13324; ROCK and NET inhibitor) And Roclatan (PG324;
ROCK inhibitor) - Aerie Pharmaceuticals
10.4.2 Drugs In Phase 1 And Pre-clinical Development For Glaucoma
10.5 Drugs For Dry Eye: Development Pipeline, 2015
10.5.1 Drugs In Phase 3 Development For Dry Eye
10.5.1.1 EBI-005 (IL-1R antagonist) - Eleven Biotherapeutics
10.5.1.2 Lifitegrast (integrin antagonist) - Shire
10.5.1.3 MIM-D3 (tyrosine kinase receptor antagonist) - Valeant
10.5.1.4 SI-614 (modified hyaluronate) - Seikagaku
10.5.2 Drugs In Phase 2 Development For Dry Eye
10.5.2.1 ESBA105 (TNF-alpha antibody) - Alcon (Novartis)
10.5.2.2 Kineret (anakinra: IL-1 receptor antagonist) - Amgen/Sobi
10.6 Other Drugs In The Development Pipeline For Ophthalmic Conditions
10.6.1 Brimonidine For Eye Whitening - Valeant
10.6.2 GS-101 (aganirsen) - Gene Signal
10.6.3 Omidria (phenylephrine/ketorolac) – Omeros
15. www.visiongain.com
Contents
11.1 Market Factors Influencing Ophthalmic Drugs
11.2 SWOT Analysis Of The Global Ophthalmic Drugs Market, 2015-2025
11.2.1 Strengths
11.2.1.1 A Healthy R&D Pipeline
11.2.1.2 Advances In Drug Delivery Technologies
11.2.1.3 Support For Reimbursement And Payment Approvals
11.2.1.4 Gene Therapy And RNA Interference Technology
11.2.1.5 New Ophthalmic Therapeutic Applications For Drugs
11.2.1.6 Development Of Neuroprotective Anti-Glaucoma Medications
11.2.1.7 Biomarkers As Tools For Better Diagnosis And Treatment
11.2.2 Weaknesses
11.2.2.1 Patient Adherence To Treatment
11.2.2.2 High Treatment Burden On Patients And Healthcare Providers
11.2.2.3 Under-Diagnosis And Under-Treatment
11.2.3 Opportunities
11.2.3.1 Sustained-Release Ocular Implants
11.2.3.2 The Impact Of A Rapidly Ageing Global Population
11.2.3.3 Increasing Prevalence Of Eye Diseases And Diabetes
11.2.3.4 Glaucoma And Retinal Disorders Will Have the Most-Marked Increases In
Prevalence
11.2.3.5 Unmet Clinical Need In Many Disease Areas
11.2.3.6 Economic Growth In Emerging Market Provide Opportunity For Expansion
11.2.4 Threats
11.2.4.1 Intensifying Price Regulation In The Market
11.2.4.2 Generic Competition – Likely Erosion Of Sales For Market Leading Brands
11.2.4.3 Rising Costs Of R&D
11. Qualitative Analysis Of The Ophthalmic Drugs Market, 2015-
2025
16. www.visiongain.com
Contents
11.2.4.4 Biosimilars – A Potent Threat To Ophthalmic Drugs’ Success
11.3 Porter’s Five Force Analysis Of The Global Ophthalmic Drugs Market, 2015-2025
11.3.1 Threat of New Entrants
11.3.2 Rivalry Among Competitors
11.3.3 Power of Suppliers
11.3.4 Threat of Substitutes
11.3.5 Power of Buyers
12.1 Interview with Dr Patrik De Haes, CEO and Mr Wouter Piepers, Global Head Of Corporate
Communications & Investor Relations At ThromboGenics nv
12.1.1 The Ophthalmic Drug Segments Presenting Growth Opportunities
12.1.2 Jetrea As A Game-Changer In The Treatment Of Vitreomacular Adhesion
12.1.3 The Need To Embrace Novel Treatments
12.1.4 Future Plans For Jetrea
12.1.5 Expanding Treatment Indications And Strategies For Maximising Product Potential
12.1.6 Will Jetrea Be A Substitute For Surgery In Vitreomacular Adhesion Patients?
12.1.7 Development Efforts For Jetrea In Retinal Vein Occlusion
12.1.8 Future Prospects For The Ophthalmic Drugs Market
12.2 Interview With A Spokesperson From Akorn Pharmaceuticals
12.2.1 New Formulation Strategies For Cosopt, Zioptan And Azasite
12.2.2 Expansion Plans For Akorn’s Ophthalmic Portfolio
12.2.3 Tackling Key Unmet Needs Within Ophthalmics
12.2.4 Akorn’s Future Plans For Growth
13. Conclusions
13.1 Overview Of Current Market Conditions And Market Forecast, 2014-2025
12. Expert Opinions From Our Primary Research
13. Conclusions
17. www.visiongain.com
Contents
13.2 Leading Sectors In Ophthalmic Drugs In 2014
13.3 Leading Regions In The Ophthalmic Drugs Market In 2014
13.4 Leading Companies In The Ophthalmic Drugs Market, 2014
13.5 What Does The Future Hold For Ophthalmic Drugs?
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Table 6.10 Azopt: Novartis Sales Forecast ($m, AGR%, CAGR%), 2014-2025
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Azopt ($m) 177 166 160 138 130 124 120 122 125 129 133 137
AGR (%) -6.4 -3.6 -13.7 -5.5 -4.6 -3.2 1.2 2.7 3.0 3.2 3.2
CAGR (%) 2014-19
CAGR (%) 2014-25
-6.8 2019-25 1.7
-2.3
Figure 6.13 Azopt: Novartis Sales Forecast ($m, AGR%), 2014-2025
6.11 Tapros (tafluprost) – Santen
Tapros (tafluprost) is a prostaglandin analogue used to treat open-angle glaucoma and ocular
hypertension. Tapros was launched in 2008. The drug is sold by Akorn under the name Zioptan
and in some countries as Saflutan, while Santen sells tafluprost as Tapros (in Japan) or Taflotan
(in other markets such as South Korea). The drug has been approved in over 30 European
-20.0
-15.0
-10.0
-5.0
0.0
5.0
0
20
40
60
80
100
120
140
160
180
200
AGR(%)
Revenue($m)
Year
Market Size ($m) AGR (%)
Source: Visiongain 2015
Source: Visiongain 2015
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Disorders, Allergic, Inflammatory & Infective Drugs
The Italian healthcare system has had to face up to various challenges over the last five years.
Servicio Sanitario Nazionale (SSN), the Italian healthcare system (a universal healthcare system
similar to the UK’s National Health Service), is challenged by decreasing budgets, increasing focus
on chronic diseases and diseases related to the elderly. Austerity measures implemented in June
2010 introduced reimbursement limits for generics, price cuts, requirements for doctors to
prescribe the cheapest generic where possible, a reduction in the pharmacy profit margin of the
end price of a drug, and a levy on drug manufacturers set at 1.83% of the price of the drug to be
paid to regional health authorities. Further regulation was passed in March 2012, and visiongain
believes more changes are likely to follow in the next ten years as the Italian government struggles
to contain healthcare spending.
We forecast the Italian ophthalmic drugs market to grow over the forecast period, from $530m in
2014 to reach $583m in 2019. A CAGR of 1.9% is expected between 2014 and 2019 (Table 8.18
and Figure 8.19). Reductions in healthcare spending and increasing governmental intervention
over pharmaceutical pricing will impact on market growth. We expect low single digit growth in this
market in the second half of the forecast period. The market will grow to $670m in 2025, with a
CAGR of 2.3% between 2019 and 2025 (Table 8.18 and Figure 8.19).
Table 8.18 The Italian Ophthalmic Drugs Market: Market Forecast ($m, AGR%, CAGR%),
2014-2025
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Italy ($m) 530 540 552 562 573 583 594 604 617 632 650 670
AGR (%) 2.0 2.2 1.8 1.9 1.7 1.9 1.8 2.1 2.4 2.8 3.1
CAGR (%) 2014-19
CAGR (%) 2014-25
1.9 2019-25 2.3
2.2
Source: Visiongain 2015
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Disorders, Allergic, Inflammatory & Infective Drugs
Clinical trials have shown that Eylea is non-inferior to Lucentis. The two large-scale Phase 3 trials,
VIEW 1 and VIEW 2 compared an Eylea regimen of 2 mg every two months (after three loading
doses) against 0.5 mg of Lucentis monthly, measuring vision maintenance and/or improvement
over a one-year period. Similar levels of effectiveness were demonstrated by both products, with
some ocular adverse events occurring in the Eylea arm (including conjunctival haemorrhage,
macular degeneration, eye pain, retinal haemorrhage and vitreous floaters most commonly) but a
safety profile similar to that of Lucentis demonstrated overall.
9.6.2 Regeneron: Recent Developments
9.6.2.1 Expanding Indications For Eylea
In July 2014, August 2014, and November 2014, the US FDA, European Commission, and the
Japanese Ministry of Health, Labour and Welfare (MHLW), respectively, approved Eylea for the
treatment of diabetic macular edema (DME). In September 2014, the Japanese MHLW approved
Eylea for myopic choroidal neovascularisation (mCNV). Additionally, in October 2014, it was
reported that the FDA had approved the drug for the treatment of macular edema following retinal
vein occlusion (RVO). This includes macular edema following branch retinal vein occlusion
(BRVO).
We note that in November 2014, the FDA was reported to have accepted for priority review the
supplemental biologics application (sBLA) for Eylea for the treatment of diabetic retinopathy in
patients with DME. In March 2015, the FDA approved the drug as a new treatment for diabetic
retinopathy in patients with diabetic macular edema.
9.6.2.2 Eylea/Zaltrap And The Davis-Smyth Patent Agreements
Genentech and Regeneron both own VEGF Trap-related patents. In early 2012, the two
companies settled their patent dispute over infringement of Genentech’s Davis-Smyth patents. The
companies entered into an amended agreement in May 2013. Under this new agreement,
Regeneron receives a global non-exclusive licence to the Davis-Smyth and other patents, for
ophthalmic administration of Eylea. Regeneron will make payments to Genentech based on US
sales of Eylea as well as sales of Eylea manufactured in the US and sold outside the US, until May
2016. In addition, Regeneron had paid a milestone payment and royalties under the original
agreement; these are set to continue. Bayer HealthCare will also share in making payments based
on the proportion of sales made by the company.
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February 2012). Alcon acquired the drug through its acquisition of ESBATech in 2009. Non-
ophthalmic indications for the drug are being developed by Delenex Therapeutics.
10.5.2.2 Kineret (anakinra: IL-1 receptor antagonist) - Amgen/Sobi
Kineret is an IL-1 receptor antagonist already approved for the treatment of moderate to severe
active rheumatoid arthritis since 2001. The drug has also been approved in Europe for the
treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) since November 2013. It has also
been approved in the US for neonatal onset multi-system inflammatory disease (NOMID), the most
severe form of CAPS, since January 2013. The drug is marketed by Swedish Orphan Biovitrum
(Sobi) under license from Amgen.
In June 2013, a study was published in JAMA Ophthalmology on the results of a Phase 1/2 trial of
topical Kineret (anakinra) in 75 patients with dry eye disease. The study found that treatment with
topical anakinra 2.5% for 12 weeks was safe and effective in patients with dry eye disease,
suggesting that Kineret could be a novel therapeutic option for dry eye. We note that the drug does
not appear to be in active development for dry eye by either Amgen or Sobi.
10.6 Other Drugs In The Development Pipeline For Ophthalmic
Conditions
Visiongain has identified some drugs in the development pipeline for other ophthalmic conditions.
Some of these products are profiled in Table 10.11.
Table 10.11 Other Pipeline Products for Ophthalmic Conditions, 2015
Name
Generic name /
Description
Company Indication
GS-101 aganirsen Gene Signal
Neovascular-
associated corneal
graft rejection
Omidria (OMS302) phenylephrine/ketorolac Omeros
Mydriasis during
surgery
DE-109 sirolimus Santen Uveitis
brimonidine brimonidine Valeant Eye whitening
IBI-80090
intraocular mephalan
injection
Icon Bioscience Retinoblastoma
Source: Visiongain 2015
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Ophthalmic Drugs Market Forecast 2015-2025: Prospects
for Leading Companies in Dry Eye, Glaucoma, Retinal
Disorders, Allergic, Inflammatory & Infective Drugs
12. Expert Opinions From Our Primary Research
Visiongain conducted interviews with key opinion leaders within the market for ophthalmic drugs.
The transcripts of one such interview is presented in this chapter of our report
12.1 Interview With Dr Patrik De Haes, CEO And Mr Wouter Piepers,
Global Head Of Corporate Communications & Investor Relations At
ThromboGenics nv
End of May 2015, Visiongain interviewed Dr Patrik De Haes, CEO and Mr Wouter Piepers, global
head of corporate communications and investor relations at ThromboGenics NV. ThromboGenics
is an integrated biopharmaceutical company focused on developing and commercialising
innovative ophthalmic medicines for the treatment of vitreo-retinal diseases.
This includes Jetrea®, the company’s lead product, as well as a number of pre-clinical projects in
ophthalmology. Topics discussed include Jetrea as a potential treatment for multiple indications,
ThromboGenics’ development efforts for the drug, and the rising interest for other new
developments within the retina treatment space.
We thank Dr De Haes and Mr Piepers for their time.
12.1.1 The Ophthalmic Drug Segments Presenting Growth Opportunities
Visiongain: Views on the current ophthalmic drugs market and ThromboGenics’ work in the
market
Wouter Piepers: The ophthalmic drug market is clearly a growing market. Factors that play here
are a global aging population, and an increasing prevalence of eye disorders, such as diabetic
retinopathy and macular degeneration.
Some elements might be slowing down that growth. Lack of awareness among people about eye
disorders, lack of access in certain parts of the world, patent expiration of certain blockbuster
drugs, and -for selective treatments-, physician’s treatment habits (surgery) preventing broader
acceptance of innovative alternative treatments. We believe that what is good for the patient, will
eventually become more of a standard, and technology developments might offer a way out for
both patient awareness and access to diagnosis and treatment.
