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Ophthalmic Drugs Market Forecast
2016-2026
Prospects for Leading Companies in Dry Eye, Glaucoma, Retinal
Disorders, Allergic, Inflammatory & Infective Drugs
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
1. Report Overview
2. An Introduction to Ophthalmic Drugs
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Contents
2.5.3 Diagnosis Of Glaucoma
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 2015
3. The Global Ophthalmic Drugs Market, 2016-2026
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Contents
3.4 The Global Ophthalmic Drugs Market: Market Forecast 2016-2026
3.5 Ophthalmic Drugs: Changing Market Shares by Sector 2016-2026
4.1 Leading Products in the Retinal Disorder Drugs Market, 2015
4.2 Retinal Disorders: Market Trends And Developments, 2016
4.2.1 The Rise And Rise Of Eylea
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 Cause ThromboGenics to Switch Focus to Their Pipeline
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 2016-2026
4.3.1 Retinal Disorder Drugs: Changing Market Shares By Leading Drugs 2016-2026
4.4 Leading Drugs For The Treatment Of Retinal Disorders
4.5 Eylea (aflibercept) - Regeneron/ Bayer/ Santen
4.5.1 Recent Approvals For Eylea
4.5.2 Eylea: Superior Clinical Outcomes than Lucentis and Avastin?
4.5.3 Eylea: Sales Forecast 2016-2026
4.5.4 Possible Combination Therapies Involving Eylea
4.6 Lucentis (ranibizumab) – Roche/ Novartis
4.6.1 Lucentis: Sales Forecast 2016-2026
4.6.2 Less Frequent Dosing Approved In US For Lucentis
4.6.3 New Indications For Lucentis
4.6.4 Possible Combination Therapy Involving Lucentis
4.7 Avastin (bevacizumab) - Roche
4. The Retinal Disorder Drugs Market: Market
Analysis and Forecast 2016-2026
www.visiongain.com
Contents
4.7.1 Avastin: Sales Forecast 2016-2026
4.7.2 Compounding Pharmacies And Safety Risks
4.8 Visudyne (verteporfin) - Valeant/ Novartis
4.8.1 Visudyne: Sales Forecast 2016-2026
4.9 Jetrea (ocriplasmin) - ThromboGenics/ Novartis
4.9.1 Jetrea: Recent Sales Performance
4.9.2 Clinical Study Plans For Jetrea
4.9.3 Jetrea: Sales Forecast 2016-2026
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 2016-2026
5.1 Leading Products In The Allergic, Inflammatory And Infective Drugs Market, 2015
5.2 Allergic, Inflammatory And Infective Drugs: Market Trends And Developments, 2016
5.2.1 The Growth Prospects For Allergic, Inflammatory And Infective Drugs
5.2.2 Topical NSAIDs Launched: Prolensa and Ilevro
5.3 Allergic, Inflammatory And Infective Drugs: Market Forecast 2016-2026
5.3.1 Allergic, Inflammatory And Infective Drugs: Changing Market Shares By Leading Drugs 2016-2026
5.4 Leading Drugs For The Treatment Of Allergic, Inflammatory And Infective Ophthalmic Conditions
5.5 Patanol And Pataday (olopatadine) - Alcon (Novartis)
5.5.1 Pataday: Sales Forecast 2016-2026
5.5.2 Impending Generic Competition For Patanol And Pataday
5. Allergic, Inflammatory & Infective Drugs Market:
Market Analysis And Forecast 2016-2026
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Contents
5.5.3 Approval Of Pazeo Solution
5.5.4 Patanol: Sales Forecast 2016-2026
5.6 Vigamox (moxifloxacin) – Alcon (Novartis)
5.6.1 Intensifying Competition And Generics Drug Challenge To Vigamox
5.6.2 Moxeza: A Next-Generation Form of Vigamox
5.6.3 Vigamox: Sales Forecast 2016-2026
5.7 TobraDex (tobramycin/dexamethasone) – Alcon (Novartis)
5.7.1 The Development And Commercialisation Of TobraDex ST
5.7.2 TobraDex: Sales Forecast 2016-2026
5.8 Cravit (levofloxacin) - Santen
5.8.1 Cravit: Sales Forecast 2016-2026
5.9 Acular (ketorolac) – Allergan (Actavis)
5.9.1 5.9.1 Acular: Sales Forecast 2016-2026
5.10 AzaSite (azithromycin) - Akorn
5.10.1 AzaSite: Sales Forecast 2016-2026
5.11 Other Allergic, Inflammatory, And Infective Drugs: Sales Forecast 2016-2026
6.1 Glaucoma Drugs: Market Overview
6.1.1 Leading Products In The Glaucoma Drugs Market, 2015
6.2 Glaucoma Drugs: Market Trends And Developments, 2016
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
6.3 Simbrinza: First Beta-Blocker-Free Combination
6.4 Glaucoma Drugs: Market Forecast 2016-2026
6.4.1 Glaucoma Drugs: Changing Market Shares By Leading Drugs 2016-2026
6. Glaucoma Drugs Market: Market Analysis And
Forecast 2016-2026
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Contents
6.5 Leading Drugs For The Treatment Of Glaucoma
6.6 Lumigan And Ganfort (bimatoprost) – Allergan (Actavis)
6.6.1 Lumigan And Ganfort: Sales Forecast 2016-2026
6.7 Xalatan And Xalacom (latanoprost) - Pfizer
6.7.1 Xalatan/Xalacom: Sales Forecast 2016-2026
6.8 Travatan/Travatan Z And DuoTrav (travoprost) - Novartis
6.8.1 Travatan/Travatan Z And DuoTrav: Sales Forecast 2016-2026
6.9 Alphagan/Alphagan P And Combigan (brimonidine) - Allergan
6.9.1 Alphagan/Alphagan P And Combigan: Sales Forecast 2016-2026
6.10 Trusopt And Cosopt/Cosopt PF (dorzolamide) – Merck/ Santen
6.10.1 Divestment Agreement With Santen And Akorn
6.10.2 Trusopt: Sales Forecast 2016-2026
6.10.3 Cosopt And Cosopt PF: Sales Forecast 2016-2026
6.11 Azopt (brinzolamide) - Novartis
6.11.1 Azopt: Sales Forecast 2016-2026
6.12 Tapros (tafluprost) – Santen
6.12.1 Tapros: Sales Forecast 2016-2026
6.13 Zioptan (tafluprost) - Akorn
6.13.1 Zioptan: Sales Forecast 2016-2026
6.14 Other Glaucoma Drugs: Sales Forecast 2016-2026
7.1 Dry Eye Drugs: Market Overview
7.1.1 Leading Products In The Dry Eye Drugs Market, 2015
7.2 Dry Eye Drugs: Market Trends And Developments, 2016
7.2.1 Restasis: Patent Elongations And Generic Challenges Creating Uncertainty
7.2.2 Intensifying Research Focused On Dry Eye
7. Dry Eye Drugs Market: Market Analysis And
Forecast 2016-2026
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Contents
7.2.3 Improving Diagnostic Tools
7.3 Dry Eye Drugs: Market Forecast 2016-2026
7.3.1 Dry Eye Drugs: Changing Market Shares By Leading Drugs 2016-2026
7.4 Leading Drugs For The Treatment Of Dry Eye
7.5 Restasis (ciclosporin) – Allergan (Actavis)
7.5.1 Restasis – Generic launch in 2016?
7.5.2 Restasis: Sales Forecast 2016-2026
7.6 Refresh Brand Products – Allergan (Actavis)
7.6.1 Refresh Brand Products: Sales Forecast 2016-2026
7.7 Hyalein (hyaluronic acid) - Santen
7.7.1 Hyalein: Sales Forecast 2016-2026
7.8 Diquas (diaquafosol) - Santen
7.8.1 Diquas: Sales Forecast 2016-2026
7.9 Other Dry Eye Drugs: Sales Forecast 2016-2026
7.10 Other Ophthalmic Drugs
7.10.1 Hetlioz (tasimelteon) - Vanda Pharmaceuticals
7.10.2 Hetlioz: Sales Forecast 2016-2026
8.1 The Ophthalmic Drugs Market By Region
8.1.1 The Global Distribution Of Ophthalmic Drugs In 2015
8.2 Leading National Markets: Forecast 2016-2026
8.2.1 Changing Market Shares By Region, 2016-2026
8.3 Regional Ophthalmic Drugs Markets: Analysis And Forecasts, 2016-2026
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. Leading National Markets For Ophthalmic Drugs,
2016-2026
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Contents
8.4.2 US Ophthalmic Drugs Market: Market Forecast 2016-2026
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, 2016-2026
8.5.2 Germany
8.5.2.1 German Ophthalmic Drugs Market: Market Forecast 2016-2026
8.5.3 France
8.5.3.1 French Ophthalmic Drugs Market: Market Forecast 2016-2026
8.5.4 UK
8.5.4.1 UK Ophthalmic Drugs Market: Market Forecast 2016-2026
8.5.4.2 Brexit – Increased Uncertainty May Affect the UK Ophthalmic Drug Market
8.5.5 Italy
8.5.5.1 Italian Ophthalmic Drugs Market: Market Forecast 2016-2026
8.5.6 Spain
8.5.6.1 Spanish Ophthalmic Drugs Market: Market Forecast 2016-2026
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 2016-2026
8.7 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 2016-2026
8.8 Brazil
8.8.1 How Will Brazil’s Growing Healthcare Influence Ophthalmic Drugs
8.8.2 Brazilian Ophthalmic Drugs Market: Market Forecast 2016-2026
8.9 Russia
8.9.1 How Will Russia’s Economic Status Affect Its Pharma Industry?
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Contents
8.9.2 Russian Ophthalmic Drugs Market: Market Forecast 2016-2026
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 2016-2026
8.11 Rest of the World
8.11.1 Rest of the World Ophthalmic Drugs Market: Market Forecast 2016-2026
9.1 Ophthalmic Drugs – A Changing Market Landscape
9.2 Leading Companies In The Ophthalmic Drugs Market, 2015
9.2.1 Ophthalmic Drugs Market: Leading Companies Forecast 2016-2026
9.2.2 Ophthalmic Drugs: Changing Market Shares By Leading Companies 2016-2026
9.3 Novartis (Alcon)
9.3.1 Novartis: Ophthalmic Drugs Portfolio, 2015
9.3.2 Novartis: Sales Forecast 2016-2026
9.3.3 Novartis: Ophthalmic Drugs Development Pipeline, 2016
9.3.4 Novartis: Recent Developments
9.3.4.1 Novartis Restructures Following Strategic Review
9.3.4.2 Novartis Licenses Ophthotech’s Fovista
9.4 Regeneron
9.4.1 Regeneron: Ophthalmic Drugs Portfolio, 2015
9.4.2 Regeneron: Recent Developments
9.4.2.1 Expanding Indications For Eylea
9.4.2.2 Eylea/Zaltrap And The Davis-Smyth Patent Agreements
9.4.3 Regeneron: Sales Forecast 2016-2026
9.4.4 Regeneron: Ophthalmic Drugs Development Pipeline, 2015
9. Leading Companies in the Ophthalmic Drugs
Market, 2016-2026
www.visiongain.com
Contents
9.5 Allergan (Actavis)
9.5.1 Allergan: Ophthalmic Drugs Portfolio
9.5.2 Allergan: Recent Developments
9.5.2.1 Ozurdex (Dexamethasone Intravitreal Implant): The First Drug Therapy for Diabetic Macular Oedema
9.5.2.2 How Real Is The Threat Of Generic Restasis?
9.5.2.3 Valeant’s Attempted Takeover Squashed By Actavis Bid
9.5.3 Allergan: Sales Forecast 2016-2026
9.5.4 Allergan: Ophthalmic Drugs Development Pipeline, 2016
9.6 Roche
9.6.1 Roche: Ophthalmic Drugs Portfolio, 2016
9.6.1.1 Lucentis: US Sales Forecast 2016-2026
9.6.2 Roche: Sales Forecast 2016-2026
9.6.3 Roche: Ophthalmic Drugs Development Pipeline, 2016
9.7 Valeant
9.7.1 Valeant: Ophthalmic Drugs Portfolio, 2015
9.7.2 Valeant: Recent Developments
9.7.2.1 Valeant’s Acquisition of Bausch and Lomb Still Driving Its Ophthalmic Portfolio
9.7.3 Valeant: Sales Forecast 2016-2026
9.7.4 Valeant: Ophthalmic Drugs Development Pipeline, 2016
9.7.5 Valeant: Difficult End to 2015 Leads to Uncertainty About Company Future
9.8 Santen
9.8.1 Santen: Ophthalmic Drugs Portfolio, 2015
9.8.2 Santen: Recent Developments
9.8.2.1 Santen Acquires Novagali Pharma
9.8.2.2 Santen Acquires Merck’s Ophthalmic Drugs Portfolio
9.8.3 Santen: Sales Forecast 2016-2026
9.8.4 Santen: Ophthalmic Drugs Development Pipeline, 2016
9.9 Bayer
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Contents
9.9.1 Bayer: Ophthalmic Drugs Portfolio
9.9.2 Bayer: Sales Forecast 2016-2026
9.10 Pfizer
9.10.1 Pfizer: Ophthalmic Drugs Portfolio, 2016
9.10.1.1 Xalatan/Xalacom – Pfizer’s Leading Ophthalmic Products
9.10.1.2 Macugen - Valeant/Pfizer
9.10.2 Pfizer: Recent Developments
9.10.2.1 Pfizer Attempts to Acquire AstraZeneca
9.10.2.2 Pfizer Attempts Merger with Allergan
9.10.3 Pfizer: Sales Forecast 2016-2026
9.10.4 Pfizer: Ophthalmic Drugs Development Pipeline, 2016
9.11 Senju
9.11.1 Senju: Ophthalmic Drugs Portfolio
9.11.2 Senju: Sales Forecast 2016-2026
9.11.3 Senju: Ophthalmic Drugs Development Pipeline, 2016
9.11.3.1 Y 39983 (SNJ 1656)
9.11.3.2 Difluprednate (SJE-2079)
10.1 The Ophthalmic Drugs Pipeline: Intensive Development Efforts In Retinal Disorders
10.2 Drugs For Retinal Disorders: Development Pipeline, 2016
10.2.1 Will Bevasiranib (RXi Pharmaceuticals) Resume Development?
10.3 Retinal Disorders: Filed or Recently Launched
10.3.1 Compaq Sipp (conbercept) - Chengdu Kanghong Pharmaceutical
10.3.2 Lipidil (fenofibrate) - Abbott
10.3.3 Iluvien (fluocinolone) – Alimera Sciences
10.4 Drugs In Phase 3 Development For Retinal Disorders
10. Ophthalmic Drugs: Research And Development
Pipeline, 2016-2026
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Contents
10.4.1 AGN150998 And MP0260 (Anti-VEGF DARPins) - Allergan
10.4.2 Fovista and Zimura – Ophthotech Corporation
10.4.3 Lampalizumab (anti-Factor D Fab) - Roche
10.4.4 MC-1101 (hydralazine) - MacuCLEAR
10.4.5 Squalamine (anti-angiogenic drug) - OHR Pharmaceutical
10.4.6 Tandospirone (serotonin 1A agonist) – Alcon (Novartis)
10.4.7 UF-021 (unoprostone) - R-Tech Ueno
10.5 Drugs In Phase 2 Development For Retinal Disorders
10.5.1 AKB-9778 (Tie2 activator) - Aerpio Therapeutics
10.5.2 Luminate (ALG-1001; Integrin peptide therapy) - Allegro/Senju
10.5.3 AGN208397 (beclomethasone) - Allergan
10.5.4 CPC 551 - Colby Pharmaceutical
10.5.5 ESBA1008 (anti-VEGF mAb) – Alcon (Novartis)
10.5.6 iCo-007 (antisense inhibitor of C-raf kinase mRNA) - iCo Therapeutics
10.5.7 LFG316 (anti-C5 mAb) - Novartis
10.5.8 Intravitreal brimonidine implant - Allergan
10.5.9 Optina (danazol) - Ampio Pharmaceuticals
10.5.10 PF-655 (synthetic siRNA) - Quark/Pfizer
10.5.11 Premiplex (SHP-607) - Shire
10.5.12 Renexus (ciliary neurotrophic factor) - Neurotech
10.5.13 Zybrestat (fosbretabulin) - Oxigene/Symphony VIDA
10.6 Drugs In Phase 1 and Pre-clinical Development for Retinal Disorders
10.6.1 BDM-E - BioDiem
10.6.2 NADPH Oxidase Inhibitors – Alimera Sciences
10.6.3 PAN-90806 (topical VEGF inhibitor) - PanOptica
10.6.4 Plasma Kallikrein Inhibitors (KVD001) - KalVista
10.6.5 QLT091001 (synthetic retinoid) – QLT
10.7 Drugs For Allergic, Inflammatory And Infective Ophthalmic Conditions: Development Pipeline, 2016
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Contents
10.8 Drugs In Phase 3 Development For Allergic, Inflammatory And Infective Ophthalmic Conditions
10.8.1 EGP-437 (dexamethasone) – EyeGate Pharmaceuticals
10.8.2 IBI-10090 and IBI-20089 - Icon Bioscience
10.8.3 KPI-121 (loteprednol etabonate) - Kala
10.9 Drugs In Phase 2 Development For Allergic, Inflammatory And Infective Ophthalmic Conditions
10.9.1 CF101 (adenosine A3 receptor agonist) - Can-Fite BioPharma and OphthaliX
10.9.2 FST-100 (povidone-iodine/dexamethasone) - Shire
10.9.3 NVC-422 (auriclosene) - NovaBay
10.9.4 Sarilumab - Regeneron
10.10 Drugs In Phase 1 And Pre-clinical Development For Allergic, Inflammatory and Infective Ophthalmic
Conditions
10.10.1 Finafloxacin - MerLion Pharmaceuticals/Novartis
10.11 Drugs For Glaucoma: Development Pipeline, 2016
10.12 Drugs In Phase 2&3 Development For Glaucoma
10.12.1 Latanoprostene Bunod (VESNEO; BOL 303259-X) - Valeant
10.12.2 AMA0076 (ROCK inhibitor) - Amakem
10.12.3 Rhopressa (AR-13324; ROCK and NET inhibitor) And Roclatan (PG324; ROCK inhibitor) - Aerie
Pharmaceuticals
10.13 Drugs In Phase 1 And Pre-clinical Development For Glaucoma
10.14 Drugs For Dry Eye: Development Pipeline, 2016
10.15 Drugs In Phase 3 Development For Dry Eye
10.15.1 EBI-005 (IL-1R antagonist) - Eleven Biotherapeutics
10.15.2 Lifitegrast (integrin antagonist) - Shire
10.15.3 Tavilermide (formerly MIM-D3 tyrosine kinase receptor antagonist) - Allergan
10.15.4 SI-614 (modified hyaluronate) - Seikagaku
10.16 Drugs In Phase 2 Development For Dry Eye
10.16.1 ESBA105 (TNF-alpha antibody) - Alcon (Novartis)
10.16.2 Kineret (anakinra: IL-1 receptor antagonist) - Amgen/Sobi
10.17 Other Drugs In The Development Pipeline For Ophthalmic Conditions
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Contents
10.17.1 Brimonidine For Eye Whitening - Valeant
10.17.2 GS-101 (aganirsen) - Gene Signal
10.17.3 Omidria (phenylephrine/ketorolac) - Omeros
11.1 Market Factors Influencing Ophthalmic Drugs
11.2 SWOT Analysis Of The Global Ophthalmic Drugs Market, 2016-2026
11.3 Strengths
11.3.1 A Healthy R&D Pipeline
11.3.2 Advances In Drug Delivery Technologies
11.3.3 Support For Reimbursement And Payment Approvals
11.3.4 Gene Therapy And RNAi Technology
11.3.5 New Ophthalmic Therapeutic Applications For Drugs
11.3.6 Development Of Neuroprotective Anti-Glaucoma Medications
11.3.7 Biomarkers As Tools For Better Diagnosis And Treatment
11.4 Weaknesses
11.4.1 Low Levels of Patient Adherence To Treatment
11.4.2 High Treatment Burden On Patients And Healthcare Providers
11.4.3 Under-Diagnosis And Under-Treatment
11.5 Opportunities
11.5.1 Sustained-Release Ocular Implants
11.5.2 The Impact Of A Rapidly Ageing Global Population
11.5.3 Increasing Prevalence of Diabetes and Ocular Disease
11.5.4 Glaucoma And Retinal Disorders Set for Most-Marked Increases in Prevalence
11.5.5 Unmet Clinical Need In Many Disease Areas
11.5.6 Economic Growth In Emerging Market Provide Opportunity For Expansion
11. Qualitative Analysis Of The Ophthalmic Drugs
Market, 2016-2026
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Contents
11.6 Threats
11.6.1 Intensifying Price Regulation In The Market
11.6.2 Generic Competition – Likely to Cause Erosion of Sales for Market Leading Brands
11.6.3 Rising Cost Of R&D
11.6.4 Biosimilars – A Bigger Threat than Generics?
11.7 Porter’s Five Force Analysis Of The Global Ophthalmic Drugs Market, 2016-2026
11.7.1 Threat of New Entrants
11.7.2 Rivalry Among Competitors
11.7.3 Power of Suppliers
11.7.4 Threat of Substitutes
11.7.5 Power of Buyers
12.1 Overview Of Current Market Conditions And Market Forecast, 2015-2026
12.2 Leading Sectors In Ophthalmic Drugs In 2015
12.3 Leading Regions In The Ophthalmic Drugs Market In 2015
12.4 Leading Companies In The Ophthalmic Drugs Market, 2015
12.5 What Does The Future Hold For Ophthalmic Drugs?
12. Conclusions
Page 198www.visiongain.com
Ophthalmic Drugs Market Forecast 2016-2026: Prospects
for Leading Companies in Dry Eye, Glaucoma, Retinal
Disorders, Allergic, Inflammatory & Infective Drugs
Figure 8.18 The UK Ophthalmic Drugs Market: Market Forecast ($m, AGR%), 2015-2026
8.5.4.2 Brexit – Increased Uncertainty May Affect the UK Ophthalmic
Drug Market
On June 23
rd
2016, the people of the UK voted to leave the EU in a referendum on the UK’s EU
membership. This result led to a drop of approximately 10% in the value of the pound against the
dollar overnight and the implications of the vote to leave (commonly referred to as Brexit) on the
ophthalmic drugs market are unkown. However it should be noted that there will be a great deal of
uncertainty in the UK over the forecast period as the country negotiates its exit from the EU and re-
negotiates trade deals with its largest trading partner. Many speculate that there will be a negative
impact on the UK economy as a result of Brexit, which may act to hinder the market. Additionally,
there may be changes in patent law, which may impact novel product entering the market. There is
also the possibility that by cutting ties with the EU, the UK may forge stronger partnerships with
other parts of the world, which may cause the economy to grow more quickly than expected
towards the end of the forecast period, allowing for more money to be spent on healthcare and
ophthalmic drugs. It should also be noted that at the time of writing the UK has not yet started the
formal process of leaving the EU and that the UK government is under no obligation to respect the
result of the referendum, however it is likely that the public vote will be upheld.
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
0
100
200
300
400
500
600
700
800
900
2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026
AGR(%)
Revenue($m)
Year
UK ($m) AGR (%)
Source: visiongain 2016
Page 226www.visiongain.com
Ophthalmic Drugs Market Forecast 2016-2026: Prospects
for Leading Companies in Dry Eye, Glaucoma, Retinal
Disorders, Allergic, Inflammatory & Infective Drugs
Table 9.4 provides an overview of Novartis’ business.
Table 9.4 Novartis: Company Overview, 2016
Company Novartis International AG
Notable
Subsidiaries
Sandoz (1996), CIBA VISION (1996),
Chiron Corporation (2006), Alcon
(2010), Fougera Pharmaceuticals
(2012)
Business Areas
Pharmaceuticals, Medical Devices
and Diagnostics, Consumer Health
Established
1996 (Formed via merger,
constituents established from 1758
onwards)
Headquarters Basel, Switzerland
FY 2015 Revenue
($m) 49,414
FY2015 Ophthalmic
Drugs Revenue ($m) 5,873
9.3.1 Novartis: Ophthalmic Drugs Portfolio, 2015
Novartis markets several ophthalmic drug products through its Alcon ophthalmic division. The
company markets drugs for a wide variety of eye disorders. Marketed drugs include Lucentis
(ranibizumab) for wet AMD. This drug is marketed jointly with Roche, with Novartis marketing the
product outside of the US market. Novartis’s ophthalmic drug business has shown resilient growth
of the last few years in the face of generic competition, particularly in the prostaglandin segment in
glaucoma in selected markets, such as the US. Key drivers for Novartis in this segment include the
combination products – DuoTrav, Travatan and Azarga. Drugs that the company is marketing for
allergy, infective, inflammatory and dry eye conditions also continue to do well in the market.
We note that the sales of Novartis’s ophthalmic drugs increased by 5% in 2014 according to
reports from the company. Lucentis also grew its sales by 5%, driven by increased use of the
product din new indications beyond wet age-related macular degeneration.
Leading drugs in Novartis’s ophthalmology portfolio include:
• Lucentis (ranibizumab) in non-US markets, discussed in Chapter 4
• Travatan/Travatan Z and DuoTrav (travoprost), discussed in Chapter 6
Source: visiongain 2016
Page 289www.visiongain.com
Ophthalmic Drugs Market Forecast 2016-2026: Prospects
for Leading Companies in Dry Eye, Glaucoma, Retinal
Disorders, Allergic, Inflammatory & Infective Drugs
reportedly initiating four US trials of its lead product LE-MPP (loteprednol etabonate MPP) in 2014:
a Phase 3 trial in post-operative inflammation and pain after cataract surgery, a Phase 2 trial in dry
eye, a Phase 2 trial in meibomian gland disease, and an “exploratory” trial in diabetic macular
oedema and retinal vein occlusion.
In April 2015, efficacy and safety data from a Phase 3 trial in ocular inflammation and pain was
released by Kala Pharmaceuticals. Furthermore, around the same time, efficacy and adverse
events data from a Phase 2 trial of the drug in dry eyes were released by the company. The
company has not announced any further development milestones for KPI-121, although the fact
that the ocular inflammation trial is listed as a ‘1
st
Phase 3 trial’ indicates that Kala intend to carry
out another Phase 3 trial before submitting their data to regulators.
10.9 Drugs In Phase 2 Development For Allergic, Inflammatory And
Infective Ophthalmic Conditions
Visiongain has identified some drugs in Phase 2 development for allergic, inflammatory, and
infective ophthalmic conditions. Some of these products are profiled in Table 10.5.
Table 10.5 Allergic, Inflammatory and Infective Drugs Pipeline: Phase 2 Drugs, 2016
Name
Generic
name/Description
Company Indication
CF101
adenosine A3 receptor
agonist
Can-Fite BioPharma /
OphthaliX
Uveitis
EBI-005 IL-1R antagonist
Eleven
Biotherapeutics
Allergic conjunctivitis
EGP-437 dexamethasone EyeGate Dry eye
FST-100
povidone-iodine /
dexamethasone
ForeSight
Biotherapeutics
Adenoviral
conjunctivitis
LE-MPP
loteprednol
etabonate mucosal
penetrating product
Kala Pharmaceuticals Blepharitis
NVC-422
auriclosene
(aganocide)
NovaBay Viral conjunctivitis
sarilumab (REGN88) anti-IL6R mAb Regeneron Uveitis
Source: visiongain 2016

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Pha0128 Ophthalmic Drugs Market Forecast 2016-2026

  • 1. ©notice This material is copyright by visiongain. It is against the law to reproduce any of this material without the prior written agreement of visiongain.You cannot photocopy, fax, download to database or duplicate in any other way any of the material contained in this report. Each purchase and single copy is for personal use only. Ophthalmic Drugs Market Forecast 2016-2026 Prospects for Leading Companies in Dry Eye, Glaucoma, Retinal Disorders, Allergic, Inflammatory & Infective Drugs
  • 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 1. Report Overview 2. An Introduction to Ophthalmic Drugs
  • 3. www.visiongain.com Contents 2.5.3 Diagnosis Of Glaucoma 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 2015 3. The Global Ophthalmic Drugs Market, 2016-2026
  • 4. www.visiongain.com Contents 3.4 The Global Ophthalmic Drugs Market: Market Forecast 2016-2026 3.5 Ophthalmic Drugs: Changing Market Shares by Sector 2016-2026 4.1 Leading Products in the Retinal Disorder Drugs Market, 2015 4.2 Retinal Disorders: Market Trends And Developments, 2016 4.2.1 The Rise And Rise Of Eylea 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 Cause ThromboGenics to Switch Focus to Their Pipeline 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 2016-2026 4.3.1 Retinal Disorder Drugs: Changing Market Shares By Leading Drugs 2016-2026 4.4 Leading Drugs For The Treatment Of Retinal Disorders 4.5 Eylea (aflibercept) - Regeneron/ Bayer/ Santen 4.5.1 Recent Approvals For Eylea 4.5.2 Eylea: Superior Clinical Outcomes than Lucentis and Avastin? 4.5.3 Eylea: Sales Forecast 2016-2026 4.5.4 Possible Combination Therapies Involving Eylea 4.6 Lucentis (ranibizumab) – Roche/ Novartis 4.6.1 Lucentis: Sales Forecast 2016-2026 4.6.2 Less Frequent Dosing Approved In US For Lucentis 4.6.3 New Indications For Lucentis 4.6.4 Possible Combination Therapy Involving Lucentis 4.7 Avastin (bevacizumab) - Roche 4. The Retinal Disorder Drugs Market: Market Analysis and Forecast 2016-2026
  • 5. www.visiongain.com Contents 4.7.1 Avastin: Sales Forecast 2016-2026 4.7.2 Compounding Pharmacies And Safety Risks 4.8 Visudyne (verteporfin) - Valeant/ Novartis 4.8.1 Visudyne: Sales Forecast 2016-2026 4.9 Jetrea (ocriplasmin) - ThromboGenics/ Novartis 4.9.1 Jetrea: Recent Sales Performance 4.9.2 Clinical Study Plans For Jetrea 4.9.3 Jetrea: Sales Forecast 2016-2026 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 2016-2026 5.1 Leading Products In The Allergic, Inflammatory And Infective Drugs Market, 2015 5.2 Allergic, Inflammatory And Infective Drugs: Market Trends And Developments, 2016 5.2.1 The Growth Prospects For Allergic, Inflammatory And Infective Drugs 5.2.2 Topical NSAIDs Launched: Prolensa and Ilevro 5.3 Allergic, Inflammatory And Infective Drugs: Market Forecast 2016-2026 5.3.1 Allergic, Inflammatory And Infective Drugs: Changing Market Shares By Leading Drugs 2016-2026 5.4 Leading Drugs For The Treatment Of Allergic, Inflammatory And Infective Ophthalmic Conditions 5.5 Patanol And Pataday (olopatadine) - Alcon (Novartis) 5.5.1 Pataday: Sales Forecast 2016-2026 5.5.2 Impending Generic Competition For Patanol And Pataday 5. Allergic, Inflammatory & Infective Drugs Market: Market Analysis And Forecast 2016-2026
  • 6. www.visiongain.com Contents 5.5.3 Approval Of Pazeo Solution 5.5.4 Patanol: Sales Forecast 2016-2026 5.6 Vigamox (moxifloxacin) – Alcon (Novartis) 5.6.1 Intensifying Competition And Generics Drug Challenge To Vigamox 5.6.2 Moxeza: A Next-Generation Form of Vigamox 5.6.3 Vigamox: Sales Forecast 2016-2026 5.7 TobraDex (tobramycin/dexamethasone) – Alcon (Novartis) 5.7.1 The Development And Commercialisation Of TobraDex ST 5.7.2 TobraDex: Sales Forecast 2016-2026 5.8 Cravit (levofloxacin) - Santen 5.8.1 Cravit: Sales Forecast 2016-2026 5.9 Acular (ketorolac) – Allergan (Actavis) 5.9.1 5.9.1 Acular: Sales Forecast 2016-2026 5.10 AzaSite (azithromycin) - Akorn 5.10.1 AzaSite: Sales Forecast 2016-2026 5.11 Other Allergic, Inflammatory, And Infective Drugs: Sales Forecast 2016-2026 6.1 Glaucoma Drugs: Market Overview 6.1.1 Leading Products In The Glaucoma Drugs Market, 2015 6.2 Glaucoma Drugs: Market Trends And Developments, 2016 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 6.3 Simbrinza: First Beta-Blocker-Free Combination 6.4 Glaucoma Drugs: Market Forecast 2016-2026 6.4.1 Glaucoma Drugs: Changing Market Shares By Leading Drugs 2016-2026 6. Glaucoma Drugs Market: Market Analysis And Forecast 2016-2026
  • 7. www.visiongain.com Contents 6.5 Leading Drugs For The Treatment Of Glaucoma 6.6 Lumigan And Ganfort (bimatoprost) – Allergan (Actavis) 6.6.1 Lumigan And Ganfort: Sales Forecast 2016-2026 6.7 Xalatan And Xalacom (latanoprost) - Pfizer 6.7.1 Xalatan/Xalacom: Sales Forecast 2016-2026 6.8 Travatan/Travatan Z And DuoTrav (travoprost) - Novartis 6.8.1 Travatan/Travatan Z And DuoTrav: Sales Forecast 2016-2026 6.9 Alphagan/Alphagan P And Combigan (brimonidine) - Allergan 6.9.1 Alphagan/Alphagan P And Combigan: Sales Forecast 2016-2026 6.10 Trusopt And Cosopt/Cosopt PF (dorzolamide) – Merck/ Santen 6.10.1 Divestment Agreement With Santen And Akorn 6.10.2 Trusopt: Sales Forecast 2016-2026 6.10.3 Cosopt And Cosopt PF: Sales Forecast 2016-2026 6.11 Azopt (brinzolamide) - Novartis 6.11.1 Azopt: Sales Forecast 2016-2026 6.12 Tapros (tafluprost) – Santen 6.12.1 Tapros: Sales Forecast 2016-2026 6.13 Zioptan (tafluprost) - Akorn 6.13.1 Zioptan: Sales Forecast 2016-2026 6.14 Other Glaucoma Drugs: Sales Forecast 2016-2026 7.1 Dry Eye Drugs: Market Overview 7.1.1 Leading Products In The Dry Eye Drugs Market, 2015 7.2 Dry Eye Drugs: Market Trends And Developments, 2016 7.2.1 Restasis: Patent Elongations And Generic Challenges Creating Uncertainty 7.2.2 Intensifying Research Focused On Dry Eye 7. Dry Eye Drugs Market: Market Analysis And Forecast 2016-2026
  • 8. www.visiongain.com Contents 7.2.3 Improving Diagnostic Tools 7.3 Dry Eye Drugs: Market Forecast 2016-2026 7.3.1 Dry Eye Drugs: Changing Market Shares By Leading Drugs 2016-2026 7.4 Leading Drugs For The Treatment Of Dry Eye 7.5 Restasis (ciclosporin) – Allergan (Actavis) 7.5.1 Restasis – Generic launch in 2016? 7.5.2 Restasis: Sales Forecast 2016-2026 7.6 Refresh Brand Products – Allergan (Actavis) 7.6.1 Refresh Brand Products: Sales Forecast 2016-2026 7.7 Hyalein (hyaluronic acid) - Santen 7.7.1 Hyalein: Sales Forecast 2016-2026 7.8 Diquas (diaquafosol) - Santen 7.8.1 Diquas: Sales Forecast 2016-2026 7.9 Other Dry Eye Drugs: Sales Forecast 2016-2026 7.10 Other Ophthalmic Drugs 7.10.1 Hetlioz (tasimelteon) - Vanda Pharmaceuticals 7.10.2 Hetlioz: Sales Forecast 2016-2026 8.1 The Ophthalmic Drugs Market By Region 8.1.1 The Global Distribution Of Ophthalmic Drugs In 2015 8.2 Leading National Markets: Forecast 2016-2026 8.2.1 Changing Market Shares By Region, 2016-2026 8.3 Regional Ophthalmic Drugs Markets: Analysis And Forecasts, 2016-2026 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. Leading National Markets For Ophthalmic Drugs, 2016-2026
  • 9. www.visiongain.com Contents 8.4.2 US Ophthalmic Drugs Market: Market Forecast 2016-2026 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, 2016-2026 8.5.2 Germany 8.5.2.1 German Ophthalmic Drugs Market: Market Forecast 2016-2026 8.5.3 France 8.5.3.1 French Ophthalmic Drugs Market: Market Forecast 2016-2026 8.5.4 UK 8.5.4.1 UK Ophthalmic Drugs Market: Market Forecast 2016-2026 8.5.4.2 Brexit – Increased Uncertainty May Affect the UK Ophthalmic Drug Market 8.5.5 Italy 8.5.5.1 Italian Ophthalmic Drugs Market: Market Forecast 2016-2026 8.5.6 Spain 8.5.6.1 Spanish Ophthalmic Drugs Market: Market Forecast 2016-2026 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 2016-2026 8.7 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 2016-2026 8.8 Brazil 8.8.1 How Will Brazil’s Growing Healthcare Influence Ophthalmic Drugs 8.8.2 Brazilian Ophthalmic Drugs Market: Market Forecast 2016-2026 8.9 Russia 8.9.1 How Will Russia’s Economic Status Affect Its Pharma Industry?
  • 10. www.visiongain.com Contents 8.9.2 Russian Ophthalmic Drugs Market: Market Forecast 2016-2026 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 2016-2026 8.11 Rest of the World 8.11.1 Rest of the World Ophthalmic Drugs Market: Market Forecast 2016-2026 9.1 Ophthalmic Drugs – A Changing Market Landscape 9.2 Leading Companies In The Ophthalmic Drugs Market, 2015 9.2.1 Ophthalmic Drugs Market: Leading Companies Forecast 2016-2026 9.2.2 Ophthalmic Drugs: Changing Market Shares By Leading Companies 2016-2026 9.3 Novartis (Alcon) 9.3.1 Novartis: Ophthalmic Drugs Portfolio, 2015 9.3.2 Novartis: Sales Forecast 2016-2026 9.3.3 Novartis: Ophthalmic Drugs Development Pipeline, 2016 9.3.4 Novartis: Recent Developments 9.3.4.1 Novartis Restructures Following Strategic Review 9.3.4.2 Novartis Licenses Ophthotech’s Fovista 9.4 Regeneron 9.4.1 Regeneron: Ophthalmic Drugs Portfolio, 2015 9.4.2 Regeneron: Recent Developments 9.4.2.1 Expanding Indications For Eylea 9.4.2.2 Eylea/Zaltrap And The Davis-Smyth Patent Agreements 9.4.3 Regeneron: Sales Forecast 2016-2026 9.4.4 Regeneron: Ophthalmic Drugs Development Pipeline, 2015 9. Leading Companies in the Ophthalmic Drugs Market, 2016-2026
  • 11. www.visiongain.com Contents 9.5 Allergan (Actavis) 9.5.1 Allergan: Ophthalmic Drugs Portfolio 9.5.2 Allergan: Recent Developments 9.5.2.1 Ozurdex (Dexamethasone Intravitreal Implant): The First Drug Therapy for Diabetic Macular Oedema 9.5.2.2 How Real Is The Threat Of Generic Restasis? 9.5.2.3 Valeant’s Attempted Takeover Squashed By Actavis Bid 9.5.3 Allergan: Sales Forecast 2016-2026 9.5.4 Allergan: Ophthalmic Drugs Development Pipeline, 2016 9.6 Roche 9.6.1 Roche: Ophthalmic Drugs Portfolio, 2016 9.6.1.1 Lucentis: US Sales Forecast 2016-2026 9.6.2 Roche: Sales Forecast 2016-2026 9.6.3 Roche: Ophthalmic Drugs Development Pipeline, 2016 9.7 Valeant 9.7.1 Valeant: Ophthalmic Drugs Portfolio, 2015 9.7.2 Valeant: Recent Developments 9.7.2.1 Valeant’s Acquisition of Bausch and Lomb Still Driving Its Ophthalmic Portfolio 9.7.3 Valeant: Sales Forecast 2016-2026 9.7.4 Valeant: Ophthalmic Drugs Development Pipeline, 2016 9.7.5 Valeant: Difficult End to 2015 Leads to Uncertainty About Company Future 9.8 Santen 9.8.1 Santen: Ophthalmic Drugs Portfolio, 2015 9.8.2 Santen: Recent Developments 9.8.2.1 Santen Acquires Novagali Pharma 9.8.2.2 Santen Acquires Merck’s Ophthalmic Drugs Portfolio 9.8.3 Santen: Sales Forecast 2016-2026 9.8.4 Santen: Ophthalmic Drugs Development Pipeline, 2016 9.9 Bayer
  • 12. www.visiongain.com Contents 9.9.1 Bayer: Ophthalmic Drugs Portfolio 9.9.2 Bayer: Sales Forecast 2016-2026 9.10 Pfizer 9.10.1 Pfizer: Ophthalmic Drugs Portfolio, 2016 9.10.1.1 Xalatan/Xalacom – Pfizer’s Leading Ophthalmic Products 9.10.1.2 Macugen - Valeant/Pfizer 9.10.2 Pfizer: Recent Developments 9.10.2.1 Pfizer Attempts to Acquire AstraZeneca 9.10.2.2 Pfizer Attempts Merger with Allergan 9.10.3 Pfizer: Sales Forecast 2016-2026 9.10.4 Pfizer: Ophthalmic Drugs Development Pipeline, 2016 9.11 Senju 9.11.1 Senju: Ophthalmic Drugs Portfolio 9.11.2 Senju: Sales Forecast 2016-2026 9.11.3 Senju: Ophthalmic Drugs Development Pipeline, 2016 9.11.3.1 Y 39983 (SNJ 1656) 9.11.3.2 Difluprednate (SJE-2079) 10.1 The Ophthalmic Drugs Pipeline: Intensive Development Efforts In Retinal Disorders 10.2 Drugs For Retinal Disorders: Development Pipeline, 2016 10.2.1 Will Bevasiranib (RXi Pharmaceuticals) Resume Development? 10.3 Retinal Disorders: Filed or Recently Launched 10.3.1 Compaq Sipp (conbercept) - Chengdu Kanghong Pharmaceutical 10.3.2 Lipidil (fenofibrate) - Abbott 10.3.3 Iluvien (fluocinolone) – Alimera Sciences 10.4 Drugs In Phase 3 Development For Retinal Disorders 10. Ophthalmic Drugs: Research And Development Pipeline, 2016-2026
  • 13. www.visiongain.com Contents 10.4.1 AGN150998 And MP0260 (Anti-VEGF DARPins) - Allergan 10.4.2 Fovista and Zimura – Ophthotech Corporation 10.4.3 Lampalizumab (anti-Factor D Fab) - Roche 10.4.4 MC-1101 (hydralazine) - MacuCLEAR 10.4.5 Squalamine (anti-angiogenic drug) - OHR Pharmaceutical 10.4.6 Tandospirone (serotonin 1A agonist) – Alcon (Novartis) 10.4.7 UF-021 (unoprostone) - R-Tech Ueno 10.5 Drugs In Phase 2 Development For Retinal Disorders 10.5.1 AKB-9778 (Tie2 activator) - Aerpio Therapeutics 10.5.2 Luminate (ALG-1001; Integrin peptide therapy) - Allegro/Senju 10.5.3 AGN208397 (beclomethasone) - Allergan 10.5.4 CPC 551 - Colby Pharmaceutical 10.5.5 ESBA1008 (anti-VEGF mAb) – Alcon (Novartis) 10.5.6 iCo-007 (antisense inhibitor of C-raf kinase mRNA) - iCo Therapeutics 10.5.7 LFG316 (anti-C5 mAb) - Novartis 10.5.8 Intravitreal brimonidine implant - Allergan 10.5.9 Optina (danazol) - Ampio Pharmaceuticals 10.5.10 PF-655 (synthetic siRNA) - Quark/Pfizer 10.5.11 Premiplex (SHP-607) - Shire 10.5.12 Renexus (ciliary neurotrophic factor) - Neurotech 10.5.13 Zybrestat (fosbretabulin) - Oxigene/Symphony VIDA 10.6 Drugs In Phase 1 and Pre-clinical Development for Retinal Disorders 10.6.1 BDM-E - BioDiem 10.6.2 NADPH Oxidase Inhibitors – Alimera Sciences 10.6.3 PAN-90806 (topical VEGF inhibitor) - PanOptica 10.6.4 Plasma Kallikrein Inhibitors (KVD001) - KalVista 10.6.5 QLT091001 (synthetic retinoid) – QLT 10.7 Drugs For Allergic, Inflammatory And Infective Ophthalmic Conditions: Development Pipeline, 2016
  • 14. www.visiongain.com Contents 10.8 Drugs In Phase 3 Development For Allergic, Inflammatory And Infective Ophthalmic Conditions 10.8.1 EGP-437 (dexamethasone) – EyeGate Pharmaceuticals 10.8.2 IBI-10090 and IBI-20089 - Icon Bioscience 10.8.3 KPI-121 (loteprednol etabonate) - Kala 10.9 Drugs In Phase 2 Development For Allergic, Inflammatory And Infective Ophthalmic Conditions 10.9.1 CF101 (adenosine A3 receptor agonist) - Can-Fite BioPharma and OphthaliX 10.9.2 FST-100 (povidone-iodine/dexamethasone) - Shire 10.9.3 NVC-422 (auriclosene) - NovaBay 10.9.4 Sarilumab - Regeneron 10.10 Drugs In Phase 1 And Pre-clinical Development For Allergic, Inflammatory and Infective Ophthalmic Conditions 10.10.1 Finafloxacin - MerLion Pharmaceuticals/Novartis 10.11 Drugs For Glaucoma: Development Pipeline, 2016 10.12 Drugs In Phase 2&3 Development For Glaucoma 10.12.1 Latanoprostene Bunod (VESNEO; BOL 303259-X) - Valeant 10.12.2 AMA0076 (ROCK inhibitor) - Amakem 10.12.3 Rhopressa (AR-13324; ROCK and NET inhibitor) And Roclatan (PG324; ROCK inhibitor) - Aerie Pharmaceuticals 10.13 Drugs In Phase 1 And Pre-clinical Development For Glaucoma 10.14 Drugs For Dry Eye: Development Pipeline, 2016 10.15 Drugs In Phase 3 Development For Dry Eye 10.15.1 EBI-005 (IL-1R antagonist) - Eleven Biotherapeutics 10.15.2 Lifitegrast (integrin antagonist) - Shire 10.15.3 Tavilermide (formerly MIM-D3 tyrosine kinase receptor antagonist) - Allergan 10.15.4 SI-614 (modified hyaluronate) - Seikagaku 10.16 Drugs In Phase 2 Development For Dry Eye 10.16.1 ESBA105 (TNF-alpha antibody) - Alcon (Novartis) 10.16.2 Kineret (anakinra: IL-1 receptor antagonist) - Amgen/Sobi 10.17 Other Drugs In The Development Pipeline For Ophthalmic Conditions
  • 15. www.visiongain.com Contents 10.17.1 Brimonidine For Eye Whitening - Valeant 10.17.2 GS-101 (aganirsen) - Gene Signal 10.17.3 Omidria (phenylephrine/ketorolac) - Omeros 11.1 Market Factors Influencing Ophthalmic Drugs 11.2 SWOT Analysis Of The Global Ophthalmic Drugs Market, 2016-2026 11.3 Strengths 11.3.1 A Healthy R&D Pipeline 11.3.2 Advances In Drug Delivery Technologies 11.3.3 Support For Reimbursement And Payment Approvals 11.3.4 Gene Therapy And RNAi Technology 11.3.5 New Ophthalmic Therapeutic Applications For Drugs 11.3.6 Development Of Neuroprotective Anti-Glaucoma Medications 11.3.7 Biomarkers As Tools For Better Diagnosis And Treatment 11.4 Weaknesses 11.4.1 Low Levels of Patient Adherence To Treatment 11.4.2 High Treatment Burden On Patients And Healthcare Providers 11.4.3 Under-Diagnosis And Under-Treatment 11.5 Opportunities 11.5.1 Sustained-Release Ocular Implants 11.5.2 The Impact Of A Rapidly Ageing Global Population 11.5.3 Increasing Prevalence of Diabetes and Ocular Disease 11.5.4 Glaucoma And Retinal Disorders Set for Most-Marked Increases in Prevalence 11.5.5 Unmet Clinical Need In Many Disease Areas 11.5.6 Economic Growth In Emerging Market Provide Opportunity For Expansion 11. Qualitative Analysis Of The Ophthalmic Drugs Market, 2016-2026
  • 16. www.visiongain.com Contents 11.6 Threats 11.6.1 Intensifying Price Regulation In The Market 11.6.2 Generic Competition – Likely to Cause Erosion of Sales for Market Leading Brands 11.6.3 Rising Cost Of R&D 11.6.4 Biosimilars – A Bigger Threat than Generics? 11.7 Porter’s Five Force Analysis Of The Global Ophthalmic Drugs Market, 2016-2026 11.7.1 Threat of New Entrants 11.7.2 Rivalry Among Competitors 11.7.3 Power of Suppliers 11.7.4 Threat of Substitutes 11.7.5 Power of Buyers 12.1 Overview Of Current Market Conditions And Market Forecast, 2015-2026 12.2 Leading Sectors In Ophthalmic Drugs In 2015 12.3 Leading Regions In The Ophthalmic Drugs Market In 2015 12.4 Leading Companies In The Ophthalmic Drugs Market, 2015 12.5 What Does The Future Hold For Ophthalmic Drugs? 12. Conclusions
  • 17. Page 198www.visiongain.com Ophthalmic Drugs Market Forecast 2016-2026: Prospects for Leading Companies in Dry Eye, Glaucoma, Retinal Disorders, Allergic, Inflammatory & Infective Drugs Figure 8.18 The UK Ophthalmic Drugs Market: Market Forecast ($m, AGR%), 2015-2026 8.5.4.2 Brexit – Increased Uncertainty May Affect the UK Ophthalmic Drug Market On June 23 rd 2016, the people of the UK voted to leave the EU in a referendum on the UK’s EU membership. This result led to a drop of approximately 10% in the value of the pound against the dollar overnight and the implications of the vote to leave (commonly referred to as Brexit) on the ophthalmic drugs market are unkown. However it should be noted that there will be a great deal of uncertainty in the UK over the forecast period as the country negotiates its exit from the EU and re- negotiates trade deals with its largest trading partner. Many speculate that there will be a negative impact on the UK economy as a result of Brexit, which may act to hinder the market. Additionally, there may be changes in patent law, which may impact novel product entering the market. There is also the possibility that by cutting ties with the EU, the UK may forge stronger partnerships with other parts of the world, which may cause the economy to grow more quickly than expected towards the end of the forecast period, allowing for more money to be spent on healthcare and ophthalmic drugs. It should also be noted that at the time of writing the UK has not yet started the formal process of leaving the EU and that the UK government is under no obligation to respect the result of the referendum, however it is likely that the public vote will be upheld. 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 0 100 200 300 400 500 600 700 800 900 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 AGR(%) Revenue($m) Year UK ($m) AGR (%) Source: visiongain 2016
  • 18. Page 226www.visiongain.com Ophthalmic Drugs Market Forecast 2016-2026: Prospects for Leading Companies in Dry Eye, Glaucoma, Retinal Disorders, Allergic, Inflammatory & Infective Drugs Table 9.4 provides an overview of Novartis’ business. Table 9.4 Novartis: Company Overview, 2016 Company Novartis International AG Notable Subsidiaries Sandoz (1996), CIBA VISION (1996), Chiron Corporation (2006), Alcon (2010), Fougera Pharmaceuticals (2012) Business Areas Pharmaceuticals, Medical Devices and Diagnostics, Consumer Health Established 1996 (Formed via merger, constituents established from 1758 onwards) Headquarters Basel, Switzerland FY 2015 Revenue ($m) 49,414 FY2015 Ophthalmic Drugs Revenue ($m) 5,873 9.3.1 Novartis: Ophthalmic Drugs Portfolio, 2015 Novartis markets several ophthalmic drug products through its Alcon ophthalmic division. The company markets drugs for a wide variety of eye disorders. Marketed drugs include Lucentis (ranibizumab) for wet AMD. This drug is marketed jointly with Roche, with Novartis marketing the product outside of the US market. Novartis’s ophthalmic drug business has shown resilient growth of the last few years in the face of generic competition, particularly in the prostaglandin segment in glaucoma in selected markets, such as the US. Key drivers for Novartis in this segment include the combination products – DuoTrav, Travatan and Azarga. Drugs that the company is marketing for allergy, infective, inflammatory and dry eye conditions also continue to do well in the market. We note that the sales of Novartis’s ophthalmic drugs increased by 5% in 2014 according to reports from the company. Lucentis also grew its sales by 5%, driven by increased use of the product din new indications beyond wet age-related macular degeneration. Leading drugs in Novartis’s ophthalmology portfolio include: • Lucentis (ranibizumab) in non-US markets, discussed in Chapter 4 • Travatan/Travatan Z and DuoTrav (travoprost), discussed in Chapter 6 Source: visiongain 2016
  • 19. Page 289www.visiongain.com Ophthalmic Drugs Market Forecast 2016-2026: Prospects for Leading Companies in Dry Eye, Glaucoma, Retinal Disorders, Allergic, Inflammatory & Infective Drugs reportedly initiating four US trials of its lead product LE-MPP (loteprednol etabonate MPP) in 2014: a Phase 3 trial in post-operative inflammation and pain after cataract surgery, a Phase 2 trial in dry eye, a Phase 2 trial in meibomian gland disease, and an “exploratory” trial in diabetic macular oedema and retinal vein occlusion. In April 2015, efficacy and safety data from a Phase 3 trial in ocular inflammation and pain was released by Kala Pharmaceuticals. Furthermore, around the same time, efficacy and adverse events data from a Phase 2 trial of the drug in dry eyes were released by the company. The company has not announced any further development milestones for KPI-121, although the fact that the ocular inflammation trial is listed as a ‘1 st Phase 3 trial’ indicates that Kala intend to carry out another Phase 3 trial before submitting their data to regulators. 10.9 Drugs In Phase 2 Development For Allergic, Inflammatory And Infective Ophthalmic Conditions Visiongain has identified some drugs in Phase 2 development for allergic, inflammatory, and infective ophthalmic conditions. Some of these products are profiled in Table 10.5. Table 10.5 Allergic, Inflammatory and Infective Drugs Pipeline: Phase 2 Drugs, 2016 Name Generic name/Description Company Indication CF101 adenosine A3 receptor agonist Can-Fite BioPharma / OphthaliX Uveitis EBI-005 IL-1R antagonist Eleven Biotherapeutics Allergic conjunctivitis EGP-437 dexamethasone EyeGate Dry eye FST-100 povidone-iodine / dexamethasone ForeSight Biotherapeutics Adenoviral conjunctivitis LE-MPP loteprednol etabonate mucosal penetrating product Kala Pharmaceuticals Blepharitis NVC-422 auriclosene (aganocide) NovaBay Viral conjunctivitis sarilumab (REGN88) anti-IL6R mAb Regeneron Uveitis Source: visiongain 2016