For an Executive Summary of this report please contact ben.suntivarakom@visiongain.com (+44 (0)20 7549 9976) or refer to our website: https://www.visiongain.com/Report/1407/Pharma-Leader-Series-Top-25-Biosimilar-Drug-Manufacturers-2015-2025

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Contents
1. Report Overview
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 Visiongain Reports
1.10 About Visiongain
2. Introduction to Ophthalmic Drugs
2.1 The Pharmaceutical Industry: a Very Brief Overview
2.2 The Global Burden of Eye Disease
2.3 Ophthalmic Drugs: Market Segmentation
2.4 Glaucoma: the ‘Silent Thief of Sight’
2.4.1 A Classification of Glaucoma
2.4.1.1 Primary Open-Angle Glaucoma
2.4.1.2 Acute Angle-Closure Glaucoma
2.4.1.3 Congenital Glaucoma
2.4.1.4 Secondary Glaucoma
2.4.1.5 Normal-Tension Glaucoma
1. Report Overview
2. Introduction to Ophthalmic Drugs

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Contents
2.4.1.6 Ocular Hypertension
2.4.2 Risk Factors for Glaucoma
2.4.3 Diagnosis of Glaucoma
2.4.4 Drug Treatment of Glaucoma
2.4.5 Laser Treatment and Surgery for Glaucoma
2.5 Age-Related Macular Degeneration (AMD)
2.5.1 Dry (non-exudative) AMD
2.5.2 Wet (exudative) AMD
2.5.3 Risk Factors for AMD
2.5.4 Diagnosis of AMD
2.5.5 Treatment of AMD
2.6 Diabetic Retinopathy (DR)
2.6.1 Diagnosis of Diabetic Retinopathy
2.6.2 Treatment of Diabetic Retinopathy
2.7 Ocular Allergy and Allergic Conjunctivitis
2.7.1 Diagnosis of Ocular Allergy
2.7.2 Treatment of Ocular Allergy
2.8 Ocular Inflammatory Disease
2.8.1 Treatment of Ocular Inflammatory Disease
2.9 Eye Infections
2.9.1 Treatment of Eye Infections
2.10 Dry Eye Syndrome
2.10.1 Treatment of Dry Eye Syndrome
2.11 Phases of Clinical Trials

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Contents
2.12 Currency Exchange Rates in This Report
3. Ophthalmic Drugs: World Market 2015-2025
3.1 The World Ophthalmic Drugs Market in 2014
3.2 World Ophthalmic Drugs Market: Sales Forecast 2015-2025
3.3 Leading Ophthalmic Drugs
3.4 Leading Companies in the Ophthalmic Drugs Market
3.4.1 Top 25 Ophthalmic Drug Manufacturers
3.5 Ophthalmic Drugs Market Segments: Sales Forecasts 2015-2025
3.5.1 Retinal Disorders Drugs Market: Sales Forecast 2015-2025
3.5.2 Allergic, Inflammatory and Infective Drugs Market: Sales Forecast 2015-2025
3.5.3 Glaucoma Drugs Market: Sales Forecast 2015-2025
3.5.4 Dry Eye Drugs Market: Sales Forecast 2015-2025
3.5.5 Other Ophthalmic Drugs Market: Sales Forecast 2015-2025
3.6 How Will Segmental Market Shares Change to 2025?
3.7 CAGR Forecasts of Ophthalmic Drugs Markets From 2014-2025
3.8 Market Attractiveness of Ophthalmic Drugs Markets in 2019
3.9 Market Attractiveness of Ophthalmic Drugs Markets in 2025
3.10 World Ophthalmic Drugs Market: Drivers and Restraints 2015-2025
3.10.1 World Ophthalmic Drugs Market: Analysis of Drivers
3.10.2 World Ophthalmic Drugs Market: Analysis of Restraints
3. Ophthalmic Drugs: World Market 2015-2025

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Contents
4. Leading US Ophthalmic Drug Manufacturers
4.1 Allergan Overview
4.1.1 Allergan: Ophthalmic Product Portfolio
4.1.1.1 Restasis: Generic Launch in 2015?
4.1.1.2 Restasis: Sales Forecast 2015-2025
4.1.1.3 Lumigan and Ganfort: Marketed in Over 67 Countries
4.1.1.4 Lumigan and Ganfort: Sales Forecast 2015-2025
4.1.1.5 Refresh Brand Products: the Range
4.1.1.6 Refresh Brand Products: Sales Forecast 2015-2025
4.1.1.7 Alphagan/Alphagan P and Combigan: Extended Lifecycle
4.1.1.8 Alphagan/Alphagan P and Combigan: Sales Forecast 2015-2025
4.1.1.9 Acular: New Forms Receiving FDA Approvals
4.1.1.10 Acular: Sales Forecast 2015-2025
4.1.1.11 Ozurdex (Dexamethasone Intravitreal Implant): The First Drug Therapy for
Diabetic Macular Oedema
4.1.2 Allergan: Ophthalmic Product Pipeline
4.1.2.1 Novadur (Intravitreal Brimonidine Implant)
4.1.2.2 AGN 208397 (Beclomethasone Intravitreal Injection)
4.1.2.3 Anti-VEGF DARPins (VEGF Inhibitors)
4.1.3 Allergan: Ophthalmic Revenue Forecast 2015-2025
4.1.3.1 Allergan: Ophthalmic Drugs Market Share Forecast 2015-2025
4.1.4 Allergan: SWOT Analysis
4.2 Merck Overview
4. Leading US Ophthalmic Drug Manufacturers 2015-2025

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Contents
4.2.1 Merck: Exiting the Ophthalmic Drugs Market
4.2.2 Merck: Ophthalmic Product Pipeline
4.2.3 Merck: Ophthalmic Drugs Sales in 2013 and 2014
4.3 Pfizer Overview
4.3.1 Pfizer: Ophthalmic Product Portfolio
4.3.1.1 Xalatan/Xalacom: First Ophthalmic Blockbuster
4.3.1.2 Xalatan/Xalacom: Sales Forecast 2015-2025
4.3.2 Pfizer: Ophthalmic Product Pipeline
4.3.3 Pfizer: Revenue Forecast 2015-2025
4.3.3.1 Pfizer: Ophthalmic Drugs Market Share Forecast 2015-2025
4.3.4 Pfizer: SWOT Analysis
4.4 Regeneron Overview
4.4.1 Regeneron: Ophthalmic Product Portfolio
4.4.1.1 Eylea: Superior Clinical Outcomes than Lucentis and Avastin?
4.4.1.2 Eylea: US Sales Forecast 2015-2025
4.4.2 Regeneron: Ophthalmic Product Pipeline
4.4.3 Regeneron: Revenue Forecast 2015-2025
4.4.3.1 Regeneron: Ophthalmic Drugs Market Share Forecast 2015-2025
4.4.4 FDA Approves Zaltrap (aflibercept)
4.4.5 Eylea/Zaltrap and the Davis-Smyth Patent Agreements
4.4.6 Regeneron: SWOT Analysis
4.5 Akorn Overview
4.5.1 Akorn: Ophthalmic Product Portfolio
4.5.1.1 AzaSite: AzaSite Plus and AzaSite Xtra Set to Drive AzaSite Sales

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Contents
4.5.1.2 AzaSite: Sales Forecast 2015-2025
4.5.1.3 Zioptan: Acquired from Merck
4.5.1.4 Zioptan: Sales Forecast 2015-2025
4.5.1.5 Cosopt/Cosopt PF: Acquired from Merck
4.5.1.6 Cosopt/Cosopt PF: US Sales Forecast 2015-2025
4.5.2 Akorn: Revenue Forecast 2015-2025
4.5.2.1 Akorn: Ophthalmic Drugs Market Share Forecast 2015-2025
4.5.3 Akorn: SWOT Analysis
5. Leading European Ophthalmic Drug Manufacturers
5.1 Bayer Overview
5.1.1 Eylea: non-US Sales Forecast 2015-2025
5.1.2 Bayer: Revenue Forecast 2015-2025
5.1.2.1 Bayer: Ophthalmic Drugs Market Share Forecast 2015-2025
5.2 Novartis (including Alcon) Overview
5.2.1 Novartis: Ophthalmic Product Portfolio
5.2.1.1 Lucentis: Best-Selling Ophthalmic Drug in 2014
5.2.1.2 Lucentis: Non-US Sales Forecast 2015-2025
5.2.1.3 Travatan/Travatan Z and DuoTrav: DuoTrav Awaiting US Approval
5.2.1.4 Travatan/Travatan Z and DuoTrav: Sales Forecast 2015-2025
5.2.1.5 Vigamox: Competes with Alcon’s Moxeza
5.2.1.6 Vigamox: Sales Forecast 2015-2025
5.2.1.7 Azopt: Marketed in Major Markets
5.2.1.8 Azopt: Sales Forecast 2015-2025
5. Leading European Ophthalmic Drug Manufacturers 2015-2025

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Contents
5.2.1.9 Jetrea: Sales Revenues Fall Short
5.2.1.10 Jetrea: Non-US Sales Forecast 2015-2025
5.2.2 Novartis: Ophthalmic Product Pipeline
5.2.2.1 Finafloxacin (MerLion Pharmaceuticals/Novartis)
5.2.2.2 AKB-9778 (Aerpio Therapeutics)
5.2.3 Novartis: Revenue Forecast 2015-2025
5.2.3.1 Novartis: Ophthalmic Drugs Market Share Forecast 2015-2025
5.2.4 Novartis: SWOT Analysis
5.3 Roche Overview
5.3.1 Roche: Ophthalmic Product Portfolio
5.3.1.1 Lucentis: US Sales Forecast 2015-2025
5.3.1.2 Avastin: Will It Remain Off-Label Use for Wet AMD?
5.3.1.3 Avastin: Sales Forecast 2015-2025
5.3.2 Roche: Ophthalmic Product Pipeline
5.3.2.1 Lampalizumab (RG7417)
5.3.3 Roche: Revenue Forecast 2015-2025
5.3.3.1 Roche: Ophthalmic Drugs Market Share Forecast 2015-2025
5.3.4 Roche: SWOT Analysis
5.3.4.1 Lucentis Granted Fourth Approval in the US
6. Leading Asia-Pacific and Other Ophthalmic Drug Manufacturers
2015-2025
6.1 Santen Overview
6.1.1 Santen: Ophthalmic Product Portfolio
6. Leading Asia-Pacific and Other Ophthalmic Drug Manufacturers
2015-2025

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Contents
6.1.1.1 Eylea: Japan Sales Forecast 2015-2025
6.1.1.2 Hyalein: Santen’s Best Selling Drug in 2014
6.1.1.3 Hyalein: Sales Forecast 2015-2025
6.1.1.4 Cosopt: Non-US Sales Forecast 2015-2025
6.1.1.5 Tapros/Taflotan: Sales Forecast 2015-2025
6.1.1.6 Diquas: Sales Forecast 2015-2025
6.1.1.7 Cravit: Higher Concentration Showing Significant Efficacy
6.1.1.8 Cravit: Sales Forecast 2015-2025
6.1.1.9 Trusopt: Non-US Sales Forecast 2015-2025
6.1.2 Santen: Ophthalmic Product Pipeline
6.1.3 Santen: Revenue Forecast 2015-2025
6.1.3.1 Santen: Ophthalmic Drugs Market Share Forecast 2015-2025
6.1.4 Santen: SWOT Analysis
6.2 Senju Overview
6.2.1 Senju: Ophthalmic Product Portfolio
6.2.2 Senju: Ophthalmic Product Pipeline
6.2.2.1 Y-39983 (SNJ-1656)
6.2.2.2 Difluprednate (SJE-2079)
6.2.3 Senju: Revenue Forecast 2015-2025
6.2.3.1 Senju: Ophthalmic Drugs Market Share Forecast 2015-2025
6.2.4 Senju: SWOT Analysis
6.3 Valeant Overview
6.3.1 Valeant: Ophthalmic Product Portfolio
6.3.1.1 Timoptic: US Sales Forecast 2015-2025

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Contents
6.3.1.2 Bromday: New Formulation Released
6.3.1.3 Bromday: Sales Forecast 2015-2025
6.3.2 Valeant: Ophthalmic Product Pipeline
6.3.2.1 Vesneo (BOL-303259-X)
6.3.2.2 MIM-D3 (tyrosine kinase receptor antagonist, Valeant)
6.3.2.3 Brimonidine for Eye Whitening (Valeant)
6.3.3 Valeant: Revenue Forecast 2015-2025
6.3.3.1 Valeant: Ophthalmic Drugs Market Share Forecast 2015-2025
6.3.4 Valeant: SWOT Analysis
6.3.4.1 Valeant’s Acquisition of Bausch and Lomb: Aggressive Expansion?
7. Emerging Ophthalmic Drug Manufacturers
7.1 Pipeline and Other Companies, 2015
7.2 Abbott: Fenofibrate Approved in Australia for Diabetic Retinopathy
7.3 Acucela
7.4 Aerie Pharmaceuticals
7.5 Aerpio Therapeutics: Developing AKB-9778
7.6 Alimera Sciences
7.6.1 Iluvien Gained Recent FDA Approval
7.6.2 NADPH Oxidase Inhibitors Offer Potential for Dry AMD
7.7 Altheos
7.8 Amakem
7.9 Ampio Pharmaceuticals
7.10 BioDiem
7. Emerging Ophthalmic Drug Manufacturers in 2015

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Contents
7.10.1 BDM-E: A High-Value Divestment?
7.11 Can-Fite BioPharma/OphthaliX
7.12 Chengdu Kanghong Pharmaceutical
7.13 Eleven Biotherapeutics
7.14 EyeGate Pharmaceuticals
7.15 Gene Signal
7.15.1 Aganirsen: Preventing Corneal Graft Rejection
7.16 GSK
7.16.1 Darapladib for Diabetic Macular Oedema
7.17 Icon Bioscience
7.18 Lpath
7.18.1 iSONEP: Antibodies Against Bioactive Lipids
7.19 MacuCLEAR
7.19.1 MC-1101: a Potential Therapy for Dry AMD
7.20 Neurotech
7.20.1 Renexus (NT-501) for Dry AMD
7.21 Omeros
7.22 Ophthotech
7.22.1 Will Roche Succeed in Acquiring Fovista?
7.22.2 Fovista: Significant Improvement on Lucentis in Phase 2 Trials
7.22.3 Zimura: Complement C5 Inhibitor
7.23 Otsuka Pharmaceutical
7.24 OXiGENE: Developing Zybrestat for Wet AMD
7.25 RXi Pharmaceuticals: Will Bevasiranib Resume Development?

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Contents
7.26 Shire
7.26.1 Lifitegrast (SHP606) for Dry Eye
7.26.2 Premiplex (SHP607): Preventing Retinopathy of Prematurity
7.27 ThromboGenics
7.27.1 Jetrea (ocriplasmin)
7.27.1.1 Jetrea: US Sales Forecast 2015-2025
7.27.2 TB-403: Anti-Placental Growth Factor
8. Qualitative Analysis of the Ophthalmic Drugs Market 2015-2025
8.1 Porter’s Five Forces Analysis of the Ophthalmic Drugs Market
8.1.1 Rivalry Among Competitors [Medium]
8.1.2 Threat of New Entrants [Low]
8.1.3 Power of Suppliers [Low]
8.1.4 Power of Buyers [Medium]
8.1.5 Threat of Substitutes [Medium]
9. Research Interviews
9.1 Interview with Dan Myers, President and CEO, Alimera Sciences
9.1.1 Alimera Sciences’ Key Products
9.1.2 Expectations for the Launch of Iluvien in the US and EU
9.1.3 Alimera Sciences’ Plans for Growth
9.1.4 Alimera Sciences’ Ophthalmic Pipelines
9.1.5 Challenges in the Ophthalmic Drugs Market
8. Qualitative Analysis of the Ophthalmic Drugs Market 2015-2025
9. Research Interviews

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Contents
9.1.6 Treatment Change in Retinal Disorders in the Next Decade
9.1.7 Successful Therapies in Ophthalmology in the Next Decade
9.1.8 Trends and Developments in the Ophthalmic Drugs Market
9.2 Interview with Dr. Leigh Hsu, Vice President, Corporate Development and Strategy, Lpath
Inc.
9.2.1 Lpath’s Work in Ophthalmology
9.2.2 Progress Update on iSONEP in Clinical Development
9.2.3 Planned Phase 3 Trials in 2015?
9.2.4 Lpath’s Plans for Growth
9.2.5 Main Unmet Needs in Ophthalmology
9.2.6 Promising New Drug Targets in Development
9.2.7 Potential Treatments for Retinal Disorders in the Next Decade
9.2.8 Trends in Ophthalmology: Combination Therapy, Implants, Delivery Methods
9.3 Interview with a Spokesperson for Vanda Pharmaceuticals, Washington DC, US
9.3.1 Commercialising Hetlioz
9.3.2 Future Prospects for Vanda
10. Conclusions
10.1 Ophthalmic Pharmaceuticals: A Growing Niche Market
10.2 The World Ophthalmic Drugs Market in 2014
10.2.1 Leading Ophthalmic Drugs Market Segments
10.2.2 Leading Ophthalmic Drugs
10.2.3 Leading Ophthalmic Drugs Companies
10.3 World Ophthalmic Drugs Market Forecast 2015-2025
10. Conclusions

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Contents
10.4 The Future of the Ophthalmic Drugs Market?
10.4.1 Increasing Revenue Concentration among Specialist Companies
10.4.2 The Rise of Generics
10.4.3 Small Companies Can Have a Big Impact
10.4.4 What Will Succeed in the Ophthalmic Drugs Market?

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Pharma Leader Series: Top 25 Ophthalmic
Drug Manufacturers 2015-2025
3.5.2 Allergic, Inflammatory and Infective Drugs Market: Sales Forecast
2015-2025
Visiongain estimates that the world market for allergic, inflammatory and infective drugs reached
revenues of $4,916m in 2014. Despite a decline in 2016 reflecting the impact of generic
competition for leading drugs, the market will grow with a CAGR of 1.9% over 2014-2019 to reach
$5,390m in 2019, and will grow at a CAGR of 3.0% over 2019-2025 to reach revenues of $6,421m
in 2025, representing an overall CAGR of 2.5% over 2014-2025.
The market for allergic, inflammatory and infective drugs will grow steadily during the forecast
period. An increase in the prevalence of ocular allergy will be offset by the competitive nature of
this market, which is characterised by a mixture of branded prescription drugs, generics and over-
the-counter (OTC) drugs, which compete to some degree on price. While various new anti-
inflammatory agents are being developed for indications such as uveitis, visiongain believes
existing therapies are likely to remain the current standard of care. The sharp drop in growth in
2016 is because of the patent expiry of Pataday and Patanol; in 2020 the decrease is due to the
patent expiry of Vigamox.
Table 3.8 and Figure 3.8 show visiongain’s forecast of the allergic, inflammatory and infective
drugs segment through to 2025.
Table 3.8 Allergic, Inflammatory and Infective Drugs Market Forecast: Revenues ($m),
AGR (%), CAGR (%), 2014-2025
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Allergic, Inflammatory &
Infective Drugs ($m)
4,916 5,071 5,000 5,111 5,251 5,390 5,420 5,576 5,770 5,976 6,192 6,421
Annual Growth Rate (%) 3.2 -1.4 2.2 2.8 2.6 0.6 2.9 3.5 3.6 3.6 3.7
CAGR (%, 2014-2019
and 2019-2025)
1.9 3.0
CAGR (%, 2014-2025) 2.5
Source: visiongain 2015

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Pharma Leader Series: Top 25 Ophthalmic
Drug Manufacturers 2015-2025
development work appears to have been undertaken in either wet AMD or diabetic
macular oedema.
Current pipeline drugs for Novartis include:
• LFG316 (anti-C5 mAb) for wet AMD
• ESBA105 (TNF-alpha antibody) for dry eye
• AL-8309 (tandospirone, a serotonin 1A agonist) for geographic atrophy
• ESBA1008 (anti-VEGFA mAb) for wet AMD.
In addition, Novartis plans to file for approval of Lucentis to treat “Choroidal neovascularization
(CNV) and macular edema (ME) secondary to conditions other than age related macular
degeneration, diabetic macular edema, retinal vein occlusion and pathologic myopia” in 2016. In
July 2013 Lucentis gained approval in the EU for choroidal neovascularisation secondary to
pathologic myopia.
5.2.2.1 Finafloxacin (MerLion Pharmaceuticals/Novartis)
In January 2011, Alcon signed a development and commercialisation agreement with MerLion
Pharmaceuticals for the rights to MerLion’s fluoroquinolone antibiotic, finafloxacin, for treating ear
infections. Under the agreement, Alcon gained the rights to develop the drug in this indication for
the North American market. Additionally, Alcon has the option to develop the drug for ophthalmic
infections, as well as having the option to license the drug for further regional markets. In pre-
clinical studies, finafloxacin demonstrated activity against many Gram-positive and Gram-negative
bacteria. In April 2012, MerLion announced that phase 3 trials for finafloxacin in treating acute otitis
externa were ready to begin in the US and Canada. The company has planned two phase 3 trials,
enrolling up to 1,000 patients across the region. However, there is little information available on the
development status of finafloxacin for eye infections.
5.2.2.2 AKB-9778 (Aerpio Therapeutics)
Novartis operates an investment platform called Novartis Venture Funds (NVF), which invests in
smaller pharmaceutical and medical devices companies with promising products. Recently, NVF
has funded Aerpio Therapeutics, Inc., a company developing AKB-9778. This drug candidate is a
first-in-class inhibitor of human protein tyrosine phosphatase beta (HPTPβ), which actives the Tie2
receptor on vascular endothelial cells to prevent abnormal growth of blood vessels and bleeding
from these vessels. AKB-9778 is being developed to treat diabetic macular oedema. The drug is
currently in phase 2 development after a phase 1/2 trial demonstrated safety and efficacy in 24

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Drug Manufacturers 2015-2025
Table 5.17 Roche: Ophthalmic Drugs Revenue ($m), AGR (%), CAGR(%), 2014-2025
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Roche ($m) 2,029 2,087 2,168 2,245 2,244 2,161 2,043 1,937 1,841 1,705 1,509 1,310
Annual Growth Rate (%) 2.9 3.9 3.5 0.0 -3.7 -5.5 -5.2 -5.0 -7.4 -11.5 -13.2
CAGR (%, 2014-2019
and 2019-2025)
1.3 -8.0
CAGR (%, 2014-2025) -3.9
Figure 5.13 Roche: Ophthalmic Drugs Revenue ($m), AGR (%), 2014-2025
5.3.3.1 Roche: Ophthalmic Drugs Market Share Forecast 2015-2025
Between 2014 and 2025, Roche’s ophthalmic drug market share will decrease from 9.4% in 2014
to 3.5% in 2025. Table 5.18 and Figure 5.14 shows Roche’s predicted share of the ophthalmic
drugs market in the forecast period.
-16.0
-14.0
-12.0
-10.0
-8.0
-6.0
-4.0
-2.0
0.0
2.0
4.0
6.0
0
500
1,000
1,500
2,000
2,500
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
AGR(%)
Sales($m)
Year Sales ($m) AGR (%)
Source: visiongain 2015
Source: visiongain 2015

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Pharma Leader Series: Top 25 Ophthalmic
Drug Manufacturers 2015-2025
Table 5.19 Roche: Ophthalmic Drugs Market SWOT Analysis, 2015-2025
Strengths Weaknesses
Lucentis is the leading brand in the
ophthalmic drugs market
Roche is dependent on Lucentis as the
major source of revenue in this sector
Lucentis is approved for mutiple indications
in major markets
Lucentis market share is limited by off-
label use of Avastin
Opportunities Threats
Lampalizumab is a promising pipeline
candidate for the untapped dry AMD market
Lucentis faces competition in the wet
AMD market from Regeneron's Eylea
Roche may have an opportunity to acquire
Fovista from Ophthotech
A Fovista approval and subsequent
acquisition by Regeneron/Bayer could
slash Lucentis revenues
Roche will take comfort from the fact that Lucentis has been approved for wider indications.
Additionally, results from a 24-month study from the two pivotal phase 3 trials (RISE and RIDE)
assessing the efficacy and safety of Lucentis in people with diabetic macular oedema were
encouraging for Roche. The data presented at the American Diabetes Association’s 71st Scientific
Sessions in June 2012 in San Diego showed that patients who received Lucentis experienced
significant, rapid and sustained improvement in vision compared with those who received placebo
(sham) injections. Patients who received Lucentis were significantly more likely to achieve 20/40
vision and experience less progression of the underlying diabetic retinopathy.
Towards the second half of the forecast period, a combination product incorporating Lucentis and
Fovista (Ophthotech) could enter the market, stealing market share from Lucentis. Fovista is in
phase 3 clinical development as a combination therapy for wet AMD. Phase 2b results reported by
Ophthotech were very positive. Three phase 3 trials of Fovista in various combinations began in
August 2013 and have an estimated primary completion date of July 2016. The competitive threat
from Fovista could become an opportunity if Roche is able to license the drug or acquire its
developer. Also in the second half of the forecast period, an approval of lampalizumab could
establish Roche as the first company in the untapped dry AMD pharmaceutical market. Some
reports suggest that lampalizumab could generate $2bn in peak sales, instantly transforming the
outlook for Roche’s future ophthalmic portfolio.
5.3.4.1 Lucentis Granted Fourth Approval in the US
The FDA has recently (Feb 2015) expanded approval on Roche’s eye blockbuster Lucentis. The
agency has given the green light for Lucentis to treat diabetic retinopathy (DR) in patients with
diabetic macular oedema (DME). The approval is based on two Phase III studies involving 759
Source: visiongain 2015

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Pharma Leader Series: Top 25 Ophthalmic
Drug Manufacturers 2015-2025
positive results. Renexus has received Orphan Drug and Fast Track designation from the FDA for
the treatment of visual loss due to retinitis pigmentosa. Currently, Renexus is in two phase 1 trials
for ischaemic optic neuropathy and glaucoma, ended in December 2013; a phase 2 trial in retinitis
pigmentosa due to end in September 2016; and a phase 2 trial in macular telangiectasia, due to
end in June 2016.
7.21 Omeros
Omeros is a Seattle, US-based clinical-stage biotech developing a range of products. Its most
advanced is Omidria (OMS302), a combination of phenylephrine and ketorolac, used to achieve
mydriasis (pupil dilation) during lens replacement surgery. Omidria received the FDA approval in
June 2014 for the use in cataract and other intraocular lens replacement procedures and it is
awaiting the European Medicines Agency (EMA) approval. The product is expected to be launched
in the US in early 2015.
7.22 Ophthotech
Ophthotech Corporation is a biopharmaceutical company based in Princeton, New Jersey, and
New York. The company is focused on developing therapies for dry and wet AMD based on
aptamer therapeutics. Figure 7.4 shows a summary of Ophthotech’s ophthalmic pipelines in 2015.
Figure 7.4 Ophthotech: Ophthalmic Drug Pipeline Progress, 2015
Aptamers are single-stranded oligonucleotides which fold in well-defined and specific three-
dimensional shapes, giving them high binding affinity and specificity to protein targets, with minimal
immunogenicity. Aptamers are also chemically stable and thus resistant to metabolic degradation
in the body, and the fact that they interact with surface proteins means they are not required to
cross cell membranes, making it easier to deliver therapeutically-efficacious levels of aptamer to
Fovista for wet AMD
Zimura for wet AMD
Preclinical Phase 1 Phase 2 Phase 3 Market
Source: Company reports; visiongain 2015