Diabetic Macular Edema / Diabetic Retinopathy – Unmet Need – Detailed, Expanded Analysis: Diabetic Macular Edema (US & EU)
Diabetic macular edema (DME) is caused by diabetes and is characterized by leaking fluid from abnormal blood vessels in the eye; this fluid can lead to swelling of the macula and visual impairment. Intravitreal vascular endothelial growth factor (VEGF) inhibitors, such as Regeneron / Bayer’s Eylea, Roche / Novartis’s Lucentis, and Roche’s Avastin, are the most common pharmacotherapies for treating DME, owing to their proven efficacy and safety. AbbVie’s Ozurdex and Alimera Sciences’ Iluvien, two long-acting corticosteroid implants, are also used to treat DME. However, these drugs all have clinical shortcomings in terms of efficacy, safety, and/or delivery, creating opportunities for new and improved alternatives. Our content examines the key treatment drivers and analyzes the greatest areas of unmet need, thereby presenting the opportunities in this space.
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QUESTIONS ANSWERED
- What are the treatment drivers and goals for DME?
- What drug attributes are key influencers, which have limited impact, and which are hidden opportunities?
- How do current therapies perform on key treatment drivers and goals for DME?
- What are the prevailing areas of unmet need and opportunity in DME?
- What trade-offs across different clinical attributes and price are acceptable to U.S. and European ophthalmologists for a hypothetical new DME drug?
PRODUCT DESCRIPTION
Unmet Need provides quantitative insight into U.S. and European physician perceptions of key treatment drivers and goals and the current level of unmet need for a specific disease. Commercial opportunities are analyzed, and the extent to which emerging therapies may capitalize on these opportunities is evaluated.
Markets covered: United States, United Kingdom, France, Germany
Primary research: Survey of 60 U.S. and 30 European ophthalmologists fielded in March 2022
Key companies: Roche, Regeneron, Novartis, Bayer, AbbVie, Alimera Sciences
Key drugs: Eylea, Lucentis, Avastin, Ozurdex, Iluvien
Table of contents
- Diabetic Macular Edema / Diabetic Retinopathy - Unmet Need - Detailed, Expanded Analysis: Diabetic Macular Edema (US & EU)
- Executive summary
- Unmet need - DME - executive summary - June 2022
- Introduction
- Overview
- Methodology
- Rationale for treatment drivers and goals selection
- Rationale for drug selection
- Products for diabetic macular edema and rationale for drug selection
- Treatment drivers and goals
- Key findings: attribute importance
- Relative importance of efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to surveyed ophthalmologists' prescribing decisions in DME
- Importance of efficacy attributes to prescribing decisions in DME: United States
- Importance of efficacy attributes to prescribing decisions in DME: Europe
- Importance of safety and tolerability attributes to prescribing decisions in DME: United States
- Importance of safety and tolerability attributes to prescribing decisions in DME: Europe
- Importance of convenience of administration attributes to prescribing decisions in DME: United States
- Importance of convenience of administration attributes to prescribing decisions in DME: Europe
- Importance of nonclinical factors to prescribing decisions in DME: United States
- Importance of nonclinical factors to prescribing decisions in DME: Europe
- Key findings: stated vs. derived importance
- Stated vs. derived importance of key efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to prescribing decisions in DME: United States
- Stated vs. derived importance of key efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to prescribing decisions in DME: Europe
- Product performance against treatment drivers and goals
- Key findings
- Overall performance of key therapies for DME: United States
- Overall performance of key therapies for DME: Europe
- Mean overall performance of key therapies for DME: United States and Europe
- Relative performance of key therapies for DME across select efficacy attributes: United States
- Relative performance of key therapies for DME across select efficacy attributes: Europe
- Relative performance of key therapies for DME across select safety and tolerability attributes: United States
- Relative performance of key therapies for DME across select safety and tolerability attributes: Europe
- Relative performance of key therapies for DME across select convenience of administration attributes: United States
- Relative performance of key therapies for DME across select convenience of administration attributes: Europe
- Relative performance of key therapies for DME across select nonclinical attributes: United States
- Relative performance of key therapies for DME across select nonclinical attributes: Europe
- Assessment of unmet need
- Key findings: unmet need in DME
- Surveyed ophthalmologistsu2019 satisfaction with the performance of key therapies for DME on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: United States
- Surveyed ophthalmologistsu2019 satisfaction with the performance of key therapies for DME on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: Europe
- Surveyed ophthalmologists' ascribed level of unmet need across key efficacy attributes in DME: United States
- Surveyed ophthalmologists' ascribed level of unmet need across key efficacy attributes in DME: Europe
- Surveyed ophthalmologists' ascribed level of unmet need across key safety and tolerability attributes in DME: United States
- Surveyed ophthalmologists' ascribed level of unmet need across key safety and tolerability attributes in DME: Europe
- Surveyed ophthalmologists' ascribed level of unmet need across key convenience of administration attributes in DME: United States
- Surveyed ophthalmologists' ascribed level of unmet need across key convenience of administration attributes in DME: Europe
- Surveyed ophthalmologists' ascribed level of unmet need across key nonclinical factors in DME: United States
- Surveyed ophthalmologists' ascribed level of unmet need across key nonclinical factors in DME: Europe
- Key findings: unmet need in DME and related indications
- Surveyed ophthalmologists' ascribed level of unmet need in DME and related indications: United States
- Surveyed ophthalmologists' ascribed level of unmet need in DME and related indications: Europe
- Opportunity analysis
- Areas of opportunity in the DME market and emerging therapy insights
- Opportunity: a new DME therapy with more-convenient dosing
- Opportunity: a novel therapy that is more effective in reducing the intraretinal fluid in DME patients
- Areas of opportunity in the DME market and emerging therapy insights
- Target product profiles
- Assessing drug development opportunities
- Target product profile methodology
- Attributes and attribute levels
- Attributes of key current and newly launched therapies for DME
- Attribute importance and part-worth utilities
- DME Target Product Profile: attribute importance
- Mean change in BCVA as measured by ETDRS letter score from baseline at one year
- Proportion of patients with absence of intraretinal fluid at one year
- Mean change from baseline in CST as measured by OCT at one year
- Incidence of serious ocular side effects at two years
- Incidence of APTC-defined ATEs at two years
- Delivery profile
- Price per year relative to Eylea (assuming five injections per year)
- Conjoint analysis-based simulation of a market scenario
- DME market simulation: share of preference of target product profiles included in the market scenario
- DME market simulation: likelihood to prescribe target product profiles included in the market scenario
- DME market simulation: target product profiles included in the market scenario
- Appendix
- Key abbreviations
- Bibliography
- Executive summary
Carolina Ruivo Pereira, Ph.D., is an analyst on the CNS/Ophthalmology Disorders team at Clarivate. Prior to joining the team, she worked as a content specialist in Cortellis, the suite of life science intelligence solutions from Clarivate. She holds a Ph.D. in biomedical sciences from Pompeu Fabra University in Barcelona, Spain, where she focused on identifying and characterizing novel genes implicated in lung carcinogenesis. She also holds a B.S. in biology from the University of Aveiro in Portugal.
Andrea S. Witt, Ph.D., is Therapy Leader of the Central Nervous System and Ophthalmology Disorders Portfolio at Clarivate, where she oversees a team of Business Insights Analysts and Senior Directors responsible for market research encompassing Neurology, Psychiatry, Pain, and Ophthalmology.
Her interests beyond specific CNS indications included the market potential for neuroprotectants and the impact of biomarkers on CNS markets. Dr. Witt’s research, analysis, and commentaries have appeared in Barron’s, Pharmaceutical Executive, PharmaVoice, Nature Medicine, and CNBC. Dr. Witt’s previous experience includes 10 years of scientific research conducted on neurodegenerative disorders at Harvard Medical School/Brigham and Women’s Hospital, Duke University, and the University of Texas-Southwestern Medical Center, where she earned her Ph.D. degree.