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Ophthalmic Drugs Market Forecast 2015-2025

Prospects for Leading Companies in Dry Eye, Glaucoma, Retinal Disorders, Allergic, Inflammatory & Infective Drugs

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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

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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

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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

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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

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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-

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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

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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

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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

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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

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Contents

9.5.2 Santen: Recent Developments

9.5.2.1 Santen Acquires Novagali Pharma

9.5.2.2 Santen Acquires Merck’s Ophthalmic Drugs Portfolio

9.5.3 Santen: Sales Forecast 2015-2025

9.5.4 Santen: Ophthalmic Drugs Development Pipeline, 2015

9.6 Regeneron

9.6.1 Regeneron: Ophthalmic Drugs Portfolio, 2015

9.6.2 Regeneron: Recent Developments

9.6.2.1 Expanding Indications For Eylea

9.6.2.2 Eylea/Zaltrap And The Davis-Smyth Patent Agreements

9.6.3 Regeneron: Sales Forecast 2015-2025

9.6.4 Regeneron: Ophthalmic Drugs Development Pipeline, 2015

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 2015-2025

9.7.4 Valeant: Ophthalmic Drugs Development Pipeline, 2015

9.8 Pfizer

9.8.1 Pfizer: Ophthalmic Drugs Portfolio, 2015

9.8.1.1 Xalatan/Xalacom – Pfizer’s Leading Ophthalmic Products

9.8.1.2 Macugen - Valeant/Pfizer

9.8.2 Pfizer: Recent Developments

9.8.2.1 Pfizer Attempts to Acquire AstraZeneca

9.8.3 Pfizer: Sales Forecast 2015-2025

9.8.4 Pfizer: Ophthalmic Drugs Development Pipeline, 2015

9.9 Bayer

9.9.1 Bayer: Ophthalmic Drugs Portfolio

9.9.2 Bayer: Sales Forecast 2015-2025

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Contents

9.10 Senju

9.10.1 Senju: Ophthalmic Drugs Portfolio

9.10.2 Senju: Sales Forecast 2015-2025

9.10.3 Senju: Ophthalmic Drugs Development Pipeline, 2015

9.10.3.1 Y 39983 (SNJ 1656)

9.10.3.2 Difluprednate (SJE-2079)

10.1 The Ophthalmic Drugs Pipeline: Intensive Development Efforts In Retinal Disorders

10.2 Drugs For Retinal Disorders: Development Pipeline, 2015

10.2.1 Will Bevasiranib (RXi Pharmaceuticals) Resume Development?

10.2.2 Retinal Disorders: Filed or Recently Launched

10.2.2.1 Compaq Sipp (conbercept) - Chengdu Kanghong Pharmaceutical

10.2.2.2 Lipidil (fenofibrate) - Abbott

10.2.2.3 Iluvien (fluocinolone) – Alimera Sciences

10.2.3 Drugs In Phase 3 Development For Retinal Disorders

10.2.3.1 Fovista and Zimura – Ophthotech Corporation

10.2.3.2 Lampalizumab (anti-Factor D Fab) - Roche

10.2.3.3 MC-1101 (hydralazine) - MacuCLEAR

10.2.3.4 Tandospirone (serotonin 1A agonist) – Alcon (Novartis)

10.2.3.5 UF-021 (unoprostone) - R-Tech Ueno

10.2.4 Drugs In Phase 2 Development For Retinal Disorders

10.2.4.1 AKB-9778 (Tie2 activator) - Aerpio Therapeutics

10.2.4.2 Luminate (ALG-1001; Integrin peptide therapy) - Allegro/Senju

10.2.4.3 AGN150998 And MP0260 (Anti-VEGF DARPins) - Allergan

10.2.4.4 AGN208397 (beclomethasone) - Allergan

10.2.4.5 CPC 551 - Colby Pharmaceutical

10.2.4.6 Darapladib And GSK933776 – GlaxoSmithKline

10. Ophthalmic Drugs: Research And Development Pipeline, 2015-

2025

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Contents

10.2.4.7 ESBA1008 (anti-VEGF mAb) – Alcon (Novartis)

10.2.4.8 iCo-007 (antisense inhibitor of C-raf kinase mRNA) - iCo Therapeutics

10.2.4.9 iSONEP (sonepcizumab) - Lpath

10.2.4.10 LFG316 (anti-C5 mAb) - Novartis

10.2.4.11 Novadur (Intravitreal brimonidine implant) - Allergan

10.2.4.12 Optina (danazol) - Ampio Pharmaceuticals

10.2.4.13 PF-655 (synthetic siRNA) - Quark/Pfizer

10.2.4.14 Premiplex (protein replacement therapy) - Shire

10.2.4.15 Renexus (ciliary neurotrophic factor) - Neurotech

10.2.4.16 Squalamine (anti-angiogenic drug) - OHR Pharmaceutical

10.2.4.17 Zybrestat (fosbretabulin) - Oxigene/Symphony VIDA

10.2.5 Drugs In Phase 1 And Pre-clinical Development For Retinal Disorders

10.2.5.1 BDM-E - BioDiem

10.2.5.2 NADPH Oxidase Inhibitors – Alimera Sciences

10.2.5.3 NS2 (aldehyde trap) - Aldeyra Therapeutics

10.2.5.4 PAN-90806 (topical VEGF inhibitor) - PanOptica

10.2.5.5 Plasma Kallikrein Inhibitors (KVD001) - KalVista

10.2.5.6 QLT091001 (synthetic retinoid) – QLT

10.3 Drugs For Allergic, Inflammatory And Infective Ophthalmic Conditions: Development Pipeline,

2015

10.3.1 Drugs In Phase 3 Development For Allergic, Inflammatory And Infective Ophthalmic

Conditions

10.3.1.1 EGP-437 (dexamethasone) – EyeGate Pharmaceuticals

10.3.1.2 IBI-10090 and IBI-20089 - Icon Bioscience

10.3.1.3 LE-MPP (loteprednol etabonate) - Kala

10.3.2 Drugs In Phase 2 Development For Allergic, Inflammatory And Infective Ophthalmic

Conditions

10.3.2.1 CF101 (adenosine A3 receptor agonist) - Can-Fite BioPharma and

OphthaliX

10.3.2.2 FST-100 (povidone-iodine/dexamethasone) - ForeSight Biotherapeutics

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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

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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

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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

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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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Ophthalmic Drugs Market Forecast 2015-2025: Prospects for Leading Companies in Dry Eye, Glaucoma, Retinal Disorders, Allergic, Inflammatory & Infective Drugs

Table 6.10 Azopt: Novartis Sales Forecast ($m, AGR%, CAGR%), 2014-2025

2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025Azopt ($m) 177 166 160 138 130 124 120 122 125 129 133 137AGR (%) -6.4 -3.6 -13.7 -5.5 -4.6 -3.2 1.2 2.7 3.0 3.2 3.2CAGR (%) 2014-19CAGR (%) 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

(%)

Rev

enue

($m

)

Year

Market Size ($m) AGR (%)

Source: Visiongain 2015

Source: Visiongain 2015

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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 2025Italy ($m) 530 540 552 562 573 583 594 604 617 632 650 670AGR (%) 2.0 2.2 1.8 1.9 1.7 1.9 1.8 2.1 2.4 2.8 3.1CAGR (%) 2014-19CAGR (%) 2014-25

1.9 2019-25 2.32.2

Source: Visiongain 2015

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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 SignalNeovascular-associated corneal graft rejection

Omidria (OMS302) phenylephrine/ketorolac Omeros Mydriasis during surgery

DE-109 sirolimus Santen Uveitisbrimonidine brimonidine Valeant Eye whitening

IBI-80090 intraocular mephalan injection

Icon Bioscience Retinoblastoma

Source: Visiongain 2015

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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.