Outlook of Diabetic Macular Edema – Current Landscape and the Way Forward

Date: Jul 03 2020
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MP Advisors
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Number of Pages: 81
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Category: Pharmaceuticals and Biotech

Global market for DME was ~$3.7 billion in 2019 with US alone contributing to 51% market share, owing to the higher incidence rates of diabetes amongst the developed nations. In 2018, ~2.4m people in the US had DME, of that only ~70% got diagnosed and treated. Following is the current treatment paradigm for DME - the first line includes Eylea (Regeneron), Lucentis (Roche/Genentech) and the second line treatment includes short term steroids implants such as dexamethasone (Ozurdex, Allergen; once every six months) or longer lasting fluocinolone acetonide (Iluvien, Alimera; once every three years). Anti-VEGFs lead the DME market due to its proven efficacy as compared to steroids, making it a premium priced segment. As a result of high cost, approved anti-VEGFs, the market witnesses extensive use of off-label us of Avastin (Roche/Genentech) and Triamcinolone acetonide - Kenalog (BMS). Despite being the last entrant in the anti-VEGF segment, Eylea has emerged as a leader owing to its superior efficacy with US market share ~69% by value ($4.6 billion) in 2019.

Although the multifactorial nature of DME has become clearer with involvement of several pathways, approved therapies target only one pathway and half of the patients continue to lose vision even after the treatments. In addition, high cost, adverse effects associated with intra-vitreal injections and limited patient convenience highlights the high unmet need. As a result, a few dozen initiatives are being undertaking to develop improved therapies for DME by a range of pharma companies globally. The late stage pipeline comprises of long-lasting VEGF blockers and compounds with VEGF-independent mechanisms such as Tie-2/Angiopoietin pathway modulators and integrin inhibitors. In the long run, non-invasive therapies (oral and topical), prophylactic treatment and gene therapy is likely to transform DME’s treatment paradigm. Current major players in the DME market, including Regeneron and Roche, are focusing on maintaining the market share with formulations improvements reducing the frequency of administration, as their products heads for patent cliff. Despite biosimilars entry, the DME drug market in the US is estimated to grow rapidly (~ $2 billion - 2020) to reach $3.3 billion by 2025 (CAGR 10%), with over 90% contribution from anti-VEGF. In the coming decade, DME treatment is likely witness a paradigm shift from invasive injectable treatments to non-invasive options. The future therapies will empower ophthalmologists with better options to manage the debilitating condition without compromising the patient’s vision and safety

.This report provides insights into:
• Epidemiology, multifactorial pathophysiology of DME, and significant role of inflammatory cascade in the progression of DME
• Current treatment paradigm, clinical development outcomes of approved and off-label drugs, real-world data comparison of the approved therapies and limitations of the current therapies
• Current and future market landscape of DME drugs (anti-VEGFs and steroids), along with the potential impact of biosimilars entry on the Innovator molecules
• In depth analyses of development pipeline (Pre-clinical -PhIII), while identifying the novel therapies with the potential to change the treatment paradigm

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
Charts & Figures:
Figures 1: PROGRESSION OF DMEFigures 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

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