Posterior Uveitis – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Posterior Uveitis – Pipeline Review, H2 2016’, provides an overview of the Posterior Uveitis pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Posterior Uveitis, complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of key players involved in therapeutic development for Posterior Uveitis and features dormant and discontinued projects.

Global Markets Direct’s report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Direct’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis.

The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage.

Note: Certain sections in the report may be removed or altered based on the availability and relevance of data.

Scope

The report provides a snapshot of the global therapeutic landscape of Posterior Uveitis

The report reviews pipeline therapeutics for Posterior Uveitis by companies and universities/research institutes based on information derived from company and industry-specific sources

The report covers pipeline products based on various stages of development ranging from pre-registration till discovery and undisclosed stages

The report features descriptive drug profiles for the pipeline products which includes, product description, descriptive MoA, R&D brief, licensing and collaboration details & other developmental activities

The report reviews key players involved Posterior Uveitis therapeutics and enlists all their major and minor projects

The report assesses Posterior Uveitis therapeutics based on drug target, mechanism of action (MoA), route of administration (RoA) and molecule type

The report summarizes all the dormant and discontinued pipeline projects

The report reviews latest news related to pipeline therapeutics for Posterior Uveitis

Reasons to buy

Gain strategically significant competitor information, analysis, and insights to formulate effective R&D strategies

Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

Identify and understand important and diverse types of therapeutics under development for Posterior Uveitis

Identify potential new clients or partners in the target demographic

Develop strategic initiatives by understanding the focus areas of leading companies

Plan mergers and acquisitions effectively by identifying key players and it’s most promising pipeline therapeutics

Devise corrective measures for pipeline projects by understanding Posterior Uveitis pipeline depth and focus of Indication therapeutics

Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope

Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline

Companies mentioned

Aciont Inc.

Neuroptis Biotech

Oculis ehf

pSivida Corp.

Regeneron Pharmaceuticals Inc

Sandoz International GmbH

Santen Pharmaceutical Co., Ltd.

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 4

List of Figures 4

Introduction 5

Global Markets Direct Report Coverage 5

Posterior Uveitis Overview 6

Therapeutics Development 7

Pipeline Products for Posterior Uveitis - Overview 7

Posterior Uveitis - Therapeutics under Development by Companies 8

Posterior Uveitis - Pipeline Products Glance 9

Late Stage Products 9

Clinical Stage Products 10

Early Stage Products 11

Posterior Uveitis - Products under Development by Companies 12

Posterior Uveitis - Companies Involved in Therapeutics Development 13

Aciont Inc. 13

Neuroptis Biotech 14

Oculis ehf 15

pSivida Corp. 16

Regeneron Pharmaceuticals Inc 17

Sandoz International GmbH 18

Santen Pharmaceutical Co., Ltd. 19

Posterior Uveitis - Therapeutics Assessment 20

Assessment by Monotherapy Products 20

Assessment by Target 21

Assessment by Mechanism of Action 23

Assessment by Route of Administration 25

Assessment by Molecule Type 27

Drug Profiles 29

adalimumab biosimilar - Drug Profile 29

Product Description 29

Mechanism Of Action 29

R&D Progress 29

dexamethasone acetate - Drug Profile 30

Product Description 30

Mechanism Of Action 30

R&D Progress 30

dexamethasone sodium phosphate - Drug Profile 31

Product Description 31

Mechanism Of Action 31

R&D Progress 31

EYS-606 - Drug Profile 33

Product Description 33

Mechanism Of Action 33

R&D Progress 33

fluocinolone acetonide SR - Drug Profile 34

Product Description 34

Mechanism Of Action 34

R&D Progress 34

NOP-3 - Drug Profile 43

Product Description 43

Mechanism Of Action 43

R&D Progress 43

sarilumab - Drug Profile 44

Product Description 44

Mechanism Of Action 44

R&D Progress 44

sirolimus - Drug Profile 49

Product Description 49

Mechanism Of Action 49

R&D Progress 49

Posterior Uveitis - Dormant Projects 52

Posterior Uveitis - Discontinued Products 53

Posterior Uveitis - Product Development Milestones 54

Featured News & Press Releases 54

Oct 04, 2016: Phase 3 trial of Medidur in Posterior Segment Uveitis Meets Enrollment Target 54

Aug 15, 2016: Topline Results from First Phase 3 Trial of pSividas Medidur Presented at ASRS Annual Meeting 54

Aug 09, 2016: Primary Endpoint Met in pSivida's Utilization Study of New Medidur Inserter with Smaller Diameter Needle 55

Jul 27, 2016: pSivida's Medidur Maintains Same High Statistical Significance in Primary Endpoint through 12 Months in First Phase 3 Trial (p Less Than

0.00000001) 55

Jul 14, 2016: Investigator-Sponsored Phase 2 Study Results Show pSivida’s Medidur Fully Controlled Uveitis for Two Years with No Recurrence of Disease While Visual Acuity Continued to Improve 56

May 02, 2016: pSividas Medidur for Posterior Uveitis Granted Orphan Drug Designation in Europe 57

Mar 15, 2016: Additional Favorable Six-Month Safety Results for pSividas Medidur for Posterior Uveitis 58

Dec 28, 2015: pSivida Plans Medidur EU Marketing Approval Application Based on Single Phase 3 Clinical Trial 58

Dec 22, 2015: pSivida Medidur Meets Primary Efficacy Endpoint in Phase 3 Trial: High Statistical Significance in Prevention of Recurrence of Posterior Uveitis 59

Sep 28, 2015: pSivida Announces NDA for Medidur Now Planned Using Six-Month Efficacy Data from Both Phase III Trials; FDA Concurs 61

May 19, 2015: pSivida Reports Positive IOP Safety Data in Phase III Trial of Medidur for Posterior Uveitis 61

Mar 26, 2015: pSivida Completes Targeted Enrollment of Phase III Trial of Medidur for Posterior Uveitis 62

Apr 15, 2013: Aciont To Present at ARVO 2013 Annual Meeting 63

Appendix 64

Methodology 64

Coverage 64

Secondary Research 64

Primary Research 64

Expert Panel Validation 64

Contact Us 64

Disclaimer 65

List of Tables

List of Tables

Number of Products under Development for Posterior Uveitis, H2 2016 7

Number of Products under Development by Companies, H2 2016 8

Comparative Analysis by Late Stage Development, H2 2016 9

Comparative Analysis by Clinical Stage Development, H2 2016 10

Comparative Analysis by Early Stage Development, H2 2016 11

Products under Development by Companies, H2 2016 12

Posterior Uveitis – Pipeline by Aciont Inc., H2 2016 13

Posterior Uveitis – Pipeline by Neuroptis Biotech, H2 2016 14

Posterior Uveitis – Pipeline by Oculis ehf, H2 2016 15

Posterior Uveitis – Pipeline by pSivida Corp., H2 2016 16

Posterior Uveitis – Pipeline by Regeneron Pharmaceuticals Inc, H2 2016 17

Posterior Uveitis – Pipeline by Sandoz International GmbH, H2 2016 18

Posterior Uveitis – Pipeline by Santen Pharmaceutical Co., Ltd., H2 2016 19

Assessment by Monotherapy Products, H2 2016 20

Number of Products by Stage and Target, H2 2016 22

Number of Products by Stage and Mechanism of Action, H2 2016 24

Number of Products by Stage and Route of Administration, H2 2016 26

Number of Products by Stage and Molecule Type, H2 2016 28

Posterior Uveitis – Dormant Projects, H2 2016 52

Posterior Uveitis – Discontinued Products, H2 2016 53

List of Figures

List of Figures

Number of Products under Development for Posterior Uveitis, H2 2016 7

Number of Products under Development by Companies, H2 2016 8

Comparative Analysis by Late Stage Development, H2 2016 9

Assessment by Monotherapy Products, H2 2016 20

Number of Products by Targets, H2 2016 21

Number of Products by Stage and Targets, H2 2016 21

Number of Products by Mechanism of Actions, H2 2016 23

Number of Products by Stage and Mechanism of Actions, H2 2016 23

Number of Products by Routes of Administration, H2 2016 25

Number of Products by Stage and Routes of Administration, H2 2016 25

Number of Products by Molecule Types, H2 2016 27

Number of Products by Stage and Molecule Types, H2 2016 27

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