Diabetic Macular Edema / Diabetic Retinopathy – Unmet Need – Detailed, Expanded Analysis: Diabetic Macular Edema (US & EU )

Diabetic macular edema (DME) represents the second-largest ophthalmology market for intravitreal anti-VEGF therapies, including Roche / Novartis’s Lucentis and Regeneron / Bayer’s market-leading Eylea. Because these therapies require regular injections to be effective, they present a major delivery burden that often impacts patient compliance. The corticosteroid implants Ozurdex (AbbVie) and Iluvien (Alimera Sciences) provide a longer duration of action between doses but are associated with side effects that relegate them to later-line treatment. Therefore, unmet need remains for therapies that provide strong efficacy for improving visual acuity with less-frequent dosing.

QUESTIONS ANSWERED

  • What are the key treatment drivers and goals for DME that influence ophthalmologists’ choice of therapies?
  • What drug attributes are key influences, which have limited impact, and which are hidden opportunities in the DME market?
  • How do ophthalmologists perceive the performance of current therapies on key treatment drivers and goals for DME?
  • What are the prevailing areas of market opportunity in the treatment of DME? Will emerging therapies, such as Novartis’s Beovu or Roche’s faricimab, fulfill these unmet needs?
  • What trade-offs are acceptable to U.S. and European ophthalmologists for a hypothetical DME drug?

PRODUCT DESCRIPTION

Unmet Need supports clinical development decisions by identifying key attributes and assessing areas of unmet need for a specific disease or subpopulation. Based on surveys with U.S. and European physicians, this report provides insight into key treatment drivers and goals, the performance of current therapies, and the remaining commercial opportunities. One market scenario is profiled in detail by Clarivate experts, and additional customized market scenarios can be evaluated with the corresponding TPP simulator.

Markets covered: United States, United Kingdom, France, Germany

Primary research: Survey of 60 U.S. and 30 European ophthalmologists fielded in February 2021

Key companies: Roche / Genentech, Regeneron / Bayer, Novartis, AbbVie (Allergan), Alimera Sciences, Kodiak Sciences

Key drugs: Lucentis, Eylea, Avastin, Ozurdex, Iluvien, Beovu, ranibizumab port delivery system, high-dose aflibercept, KSI-301, faricimab

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 - April 2021
    • 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 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 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
          • Attributes of Key Current and Late-Phase Emerging 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
          • % 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 APTCu2013Defined 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

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