Diabetic macular edema (DME) occurs as a consequence of diabetes. It typically develops in the advanced stage of diabetic retinopathy and is characterized by leaking fluid from abnormal blood vessels in the eye, which can lead to swelling of the macula and visual impairment. Intravitreal vascular endothelial growth factor (VEGF) inhibitors, such as Regeneron/Bayer HealthCare’s Eylea, Roche/Genentech/Novartis’s Lucentis, and Roche/Genentech’s Avastin, are the most common pharmacotherapies used to treat DME because of their proven efficacy and safety. Allergan’s Ozurdex and Alimera Sciences’ Iluvien, two long-acting corticosteroid implants, are also used to treat DME. However, all of these drugs present clinical shortcomings in 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 and thereby the opportunities in this space.

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 physicians perceive the current therapies as performing 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 drug for DME?

Product Description

Unmet Need: Provides quantitative insight into U.S. and European physicians’ 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 ophthalmologists in the United States and 32 ophthalmologists in Europe

Key companies: Roche/Genentech, Novartis, Regeneron, Bayer HealthCare, Allergan, Alimera Sciences

Key drugs:Lucentis, Eylea, Avastin, Ozurdex, Iluvien, triamcinolone

Key metrics included:

  • Stated versus derived analysis of U.S. and European physicians’ prescribing behavior.
  • Conjoint analysis with U.S. and European physicians, including market simulator.
  • Assessment of current drug performance against treatment drivers and goals.
  • Physician perceptions of unmet need in disease/subpopulation covered and related diseases/subpopulations.
  • Analysis of remaining drug development opportunities.

Table of contents

  • Diabetic Macular Edema / Diabetic Retinopathy - Unmet Need - Detailed, Expanded Analysis: Diabetic Macular Edema (US & EU )
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Efficacy
        • Safety and Tolerability
        • Convenience of Administration
        • Nonclinical Factors
      • Rationale for Drug Selection
        • Products for DME
    • 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
      • 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 Ophthalmologists’ Satisfaction with the Performance of Key Therapies for DME on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
      • Surveyed Ophthalmologists’ 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 Novel Therapy Offering Greater Effect on Visual Acuity in Patients with DME
        • Opportunity: A New Therapy for DME with a More-Convenient Delivery Profile
    • Target Product Profiles
      • Assessing Drug Development Opportunities
      • Target Product Profile Methodology
        • Attributes and Attribute Levels
      • 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
        • Percentage of Patients with ≥ 15 Letter Gain in BCVA from Baseline at One Year
        • Mean Change from Baseline in CRT 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 Simulations of Market Scenarios
        • DME Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 1
        • DME Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 1
        • DME Market Simulations: Target Product Profiles Included in Scenario 1
        • DME Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 2
        • DME Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 2
        • DME Market Simulations: Target Product Profiles Included in Scenario 2
    • Appendix
      • Key Abbreviations
      • Bibliography

Author(s): Niyati Khetarpal, Ph.D

"Niyati Khetarpal is a business insights analyst on the Central Nervous System, Pain, and Ophthalmology team at Decision Resources Group. In this role, she conducts primary and secondary research to analyze pharmaceutical markets, with a focus on neurology indications, including epilepsy and MS. She also has specific expertise in patent/IP research. Prior to joining the company, Niyati obtained her doctorate from the International Centre for Genetic Engineering and Biotechnology for her research on Dengue virus vaccines. She received the Fulbright-Nehru doctoral scholarship in 2014 for her research on Dengue and West Nile virus envelope proteins.”


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