Table of Content

CHAPTER 1: EXECUTIVE SUMMARY  
CHAPTER 2: DME IS JUST NOT A VEGF DISEASE - INFLAMMATORY CASCADE AND ANGIOGENESIS, WHAT IMPACTS THE MOST?
• Multifactorial nature of DME has become clearer, inflammation is a very early event in the development of DME
• Targeting pathways beyond VEGF such as inflammatory and oxidative pathways holds the key for future treatment success 

CHAPTER 3: DME - AN INCREASING ECONOMIC AND QUALITY OF LIFE BURDEN GLOBALLY 
• Increasing incidences of DME driven by the rising rates of diabetes and ageing population globally
• Geographic differences with current DME related treatment burden will be diminished in the future as the treatment paradigm standardizes

CHAPTER 4: SHIFTING TREATMENT PARADIGMS OF DME
• Anti-VEGF treatments have replaced laser as first line therapy with proven efficacy
• A definite role of steroids in the treatment paradigm, as inflammatory pathway has a major role to play
• Large unmet need remains as half of the DME patients have sub-optimal responses to the current therapies; greater personalization is still in need
• Clinical data comparison of current treatments with real world data are indicative of early stage treatment and optimal number of dosage frequencies for better outcome 
• Geography specific difference in the treatment of DME – availability of new treatments to change the treatment paradigm 

CHAPTER 5: NOVEL PIPELINE CANDIDATES TO TRANSFORM THE TREATMENT PARADIGM BY ADDRESSING THE KEY UNMET NEEDS - LONGER DURABILITY AND IMPROVED DELIVERY PROFILES
• Next generation anti-VEGF agents in development focus on durability with less frequent dosing than the current treatments
• Drugs in clinical development with potential as a combination therapy with existing standard of care anti-VEGF-A therapies to address DME patients who respond sub-optimally or become refractory to existing therapies
• Non-VEGF targets to act upstream to address all oxidative pathways with potential to reduce treatment burden, improve visual outcomes – A solution to the sub-optimal efficacy of current treatment
• Potential of gene therapy to transform the DME treatment landscape - One-time treatment for the patients who have demonstrated a strong dependence on frequent anti-VEGF treatments
• Novel oral and topical therapies could transform the standard of care with non-invasive and prophylactic treatment
• Sustained drug delivery treatment to address the current need for frequent intravitreal injections

CHAPTER 6: EVEN AMIDST BIOSIMILARS ENTRY, THE HIGH-COST DME DRUG MARKET IN THE US IS ESTIMATED TO GROW RAPIDLY DUE TO THE ENTRY OF DRUGS WITH MORE DURABILITY, NON-INVASIVE TREATMENT OPTIONS AND EVENTUALLY WITH THE ENTRY OF GENE THERAPY
• Anti-VEGFs leads the current DME market due to its proven efficacy compared to steroids
• Off-label use of Avastin and Triamcinolone acetonide are indicative of price sensitivity influence on prescription and insurance coverage
• Current market landscape of anti-VEGFs, steroids and potential pipeline compounds to drive market growth in the DME sector
• Impact of biosimilars in the current landscape

Table 1: NOVEL DME THERAPIES IN DEVELOPMENT AND UPCOMING DEVELOPMENT  
               MILESTONES
Table 2: TREATMENT OF DIABETIC MACULAR EDEMA IN THE US
Table 3: STUDIES OF ANTI-VEGF AGENTS AND CHANGE IN BCVA IN DME PATIENTS 
Table 4: STUDIES OF STERIOD AGENTS AND CHANGE IN BCVA IN DME PATIENTS
Table 5: NEW TRIAMCINOLONE ACETONIDE (MAQAID) DETAILS
Table 6: INDIRECT COMAPRISON OF MAQAID WITH OTHER OPHTHALMIC
                STERIODS FOR DME
Table 7: NOVEL DME THERAPIES IN DEVELOPMENT
Table 8: DME PIPELINE -PHASE III
Table 9: DME PIPELINE -PHASE II
Table 10: DME PIPELINE -PHASE I
Table 11: DME PIPELINE -PRE-CLINICAL

Figures 1: PROGRESSION OF DME
Figures 2: PATHOLOGY OF DME VISIBLE ON OCT IMAGING
Chart 1: NUMBER OF DME TREATED PATIENTS IN THE US (2014-2019)
Chart 2: US DME THERAPEUTIC MARKET SIZE IN 2019 AND 2025
Chart 3: US ANTI-VEGF THERAPEUTIC MARKET SIZE, 2014-2019
Chart 4: VALUE AND VOLUME SHARES OF CURRENT OPHTHALMIC ANTI-VEGF’S IN THE  
                US
Chart 5: US DME ANTI-VEGF THERAPEUTIC MARKET SIZE – 2019
Chart 6: US DME ANTI-VEGF THERAPEUTIC MARKET SIZE, 2020-2025
Chart 7: US DME-ANTI-VEGF OPHTHALMIC VALUE MARKET SHARE IN 2025
Chart 8: US STERIOD OPHTHALMIC MARKET SIZE BY VALUE, 2014-2019
Chart 9: US STERIOD OPHTHALMIC MARKET SIZE BY VOLUME, 2014-2019
Chart 10:  US DME STERIODS THERAPEUTIC MARKET SIZE IN 2019 AND IN 2025