DED is one of the most common ocular conditions in the United States and Europe. Inflammation plays a prominent role in the pathogenesis of DED, and the condition may eventually lead to damage to the ocular surface. Patients can present with different signs and symptoms, making diagnosis and disease management highly complex, particularly for patients with moderate to severe DED. Indeed, few therapies are approved specifically for the treatment of DED in the United States or Europe, with a high failure rate in clinical trials. As such, unmet need remains strong in DED, and multiple opportunities exist for novel therapies that offer improvements over existing options.

QUESTIONS ANSWERED

  • How do ophthalmologists rate Allergan’s Restasis and Takeda’s Xiidra (in the United States) and Santen’s Ikervis (in Europe) as performing on key treatment drivers and goals for moderate to severe DED?
  • Which attributes are key influencers, which have limited impact, and which are hidden opportunities for drug differentiation in moderate to severe DED?
  • What are the prevailing areas of unmet need and opportunity in the treatment of moderate to severe DED?
  • What trade-offs across key drug attributes and price are acceptable to ophthalmologists for a hypothetical new drug for moderate to severe DED?

CONTENT HIGHLIGHTS

Geographies: United States, France, Germany, United Kingdom

Primary Research: Survey of 63 U.S. and 31 European ophthalmologists

Key Drugs Covered: Restasis (U.S.), Xiidra (U.S.), Ikervis (Europe), Cequa (U.S.), KPI-121 0.25%, CyclASol, HL036, voclosporin ophthalmic solution

Key Metrics Included:

Target Product Profile (TPP) simulator based on conjoint analysis methodology.

Stated versus derived importance of product attributes on prescribing behavior.

Assessment of current drug performance against treatment drivers and goals.

Physician perceptions of unmet needs in the indication and related indications.

Analysis of remaining drug development opportunities.

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. Two market scenarios are profiled in detail by DRG experts, and additional customized market scenarios can be evaluated with the corresponding TPP simulator.

Table of contents

  • Dry Eye - Unmet Need - Detailed, Expanded Analysis (US/EU5)
    • 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 Moderate to Severe Dry Eye Disease
    • 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 Moderate to Severe Dry Eye Disease
      • Importance of Efficacy Attributes to Prescribing Decisions in Moderate to Severe Dry Eye Disease: United States
      • Importance of Efficacy Attributes to Prescribing Decisions in Moderate to Severe Dry Eye Disease: Europe
      • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Moderate to Severe Dry Eye Disease: United States
      • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Moderate to Severe Dry Eye Disease: Europe
      • Importance of Convenience of Administration Attributes to Prescribing Decisions in Moderate to Severe Dry Eye Disease: United States
      • Importance of Convenience of Administration Attributes to Prescribing Decisions in Moderate to Severe Dry Eye Disease: Europe
      • Importance of Nonclinical Factors to Prescribing Decisions in Moderate to Severe Dry Eye Disease: United States
      • Importance of Nonclinical Factors to Prescribing Decisions in Moderate to Severe Dry Eye Disease: 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 Moderate to Severe Dry Eye Disease: United States
      • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Moderate to Severe Dry Eye Disease: Europe
    • Product Performance Against Treatment Drivers and Goals
      • Key Findings
      • Overall Performance of Key Therapies for Moderate to Severe Dry Eye Disease: United States
      • Overall Performance of Key Therapies for Moderate to Severe Dry Eye Disease: Europe
      • Mean Overall Performance of Key Therapies for Moderate to Severe Dry Eye Disease: United States and Europe
      • Relative Performance of Key Therapies for Moderate to Severe Dry Eye Disease Across Select Efficacy Attributes: United States
      • Relative Performance of Key Therapies for Moderate to Severe Dry Eye Disease Across Select Efficacy Attributes: Europe
      • Relative Performance of Key Therapies for Moderate to Severe Dry Eye Disease Across Select Safety and Tolerability Attributes: United States
      • Relative Performance of Key Therapies for Moderate to Severe Dry Eye Disease Across Select Safety and Tolerability Attributes: Europe
      • Relative Performance of Key Therapies for Moderate to Severe Dry Eye Disease Across Select Convenience of Administration Attributes: United States
      • Relative Performance of Key Therapies for Moderate to Severe Dry Eye Disease Across Select Convenience of Administration Attributes: Europe
      • Relative Performance of Key Therapies for Moderate to Severe Dry Eye Disease Across Select Nonclinical Attributes: United States
      • Relative Performance of Key Therapies for Moderate to Severe Dry Eye Disease Across Select Nonclinical Attributes: Europe
    • Assessment of Unmet Need
      • Key Findings: Unmet Need in Moderate to Severe Dry Eye Disease
      • Surveyed Ophthalmologists’ Satisfaction with the Performance of Key Therapies for Moderate to Severe Dry Eye Disease on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
      • Surveyed Ophthalmologists’ Satisfaction with the Performance of Key Therapies for Moderate to Severe Dry Eye Disease on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
      • Surveyed Ophthalmologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Moderate to Severe Dry Eye Disease: United States
      • Surveyed Ophthalmologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Moderate to Severe Dry Eye Disease: Europe
      • Surveyed Ophthalmologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Moderate to Severe Dry Eye Disease: United States
      • Surveyed Ophthalmologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Moderate to Severe Dry Eye Disease: Europe
      • Surveyed Ophthalmologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Moderate to Severe Dry Eye Disease: United States
      • Surveyed Ophthalmologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Moderate to Severe Dry Eye Disease: Europe
      • Surveyed Ophthalmologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Moderate to Severe Dry Eye Disease: United States
      • Surveyed Ophthalmologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Moderate to Severe Dry Eye Disease: Europe
      • Key Findings: Unmet Need in Moderate to Severe Dry Eye Disease and Related Indications
      • Surveyed Ophthalmologists' Ascribed Level of Unmet Need in Moderate to Severe Dry Eye Disease and Related Indications: United States
      • Surveyed Ophthalmologists' Ascribed Level of Unmet Need in Moderate to Severe Dry Eye Disease and Related Indications: Europe
    • Opportunity Analysis
      • Areas of Opportunity in the Moderate to Severe Dry Eye Disease Market and Emerging Therapy Insights
        • Opportunity: A Therapy Offering a Greater Reduction in the Severity and/or Frequency of Symptoms in Moderate to Severe Dry Eye Disease
        • Opportunity: A Therapy Offering Greater Improvement in the Signs of Ocular Surface Damage in Moderate to Severe Dry Eye Disease
        • Opportunity: A Therapy Offering Greater Improvement in Tear Production in Moderate to Severe Dry Eye Disease
        • Opportunity: A Therapy Offering an Earlier Onset of Action for Improvement in the Signs and/or Symptoms of Dry Eye Disease
        • Key Attributes of Notable Late-Phase Therapies for Dry Eye Disease in the United States and Europe
    • Target Product Profiles
      • Assessing Drug Development Opportunities
      • Target Product Profile Methodology
        • Attributes and Attribute Levels
        • Attributes of Key Current Therapies for Moderate to Severe Dry Eye Disease
      • Attribute Importance and Part-Worth Utilities
        • Moderate to Severe Dry Eye Disease Target Product Profile: Attribute Importance
        • Signs: Mean Change from Baseline in the Total CFS Score at Week 12 (by Oxford Scale)
        • Tear Production: Mean Change from Baseline in STT (Unanesthetized) at Week 12
        • Symptom Severity: Mean Change from Baseline in EDS on VAS at Week 12
        • Symptom Frequency: Mean Change from Baseline in Total OSDI at Week 12
        • Onset of Action for Improvement in Signs and/or Symptoms of Dry Eye
        • Ocular Side Effect: % of Patients with Eye Irritation at Week 12
        • Price per Treated Day
      • Conjoint Analysis-Based Simulations of Market Scenarios
        • Moderate to Severe Dry Eye Disease Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 1
        • Moderate to Severe Dry Eye Disease Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 1
        • Moderate to Severe Dry Eye Disease Market Simulations: Target Product Profiles Included in Scenario 1
        • Moderate to Severe Dry Eye Disease Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 2
        • Moderate to Severe Dry Eye Disease Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 2
        • Moderate to Severe Dry Eye Disease Market Simulations: Target Product Profiles Included in Scenario 2
    • Appendix
      • Key Abbreviations
      • Experts Interviewed
      • Bibliography

Author(s): Himanshu Jain, M.S. Pharm

Himanshu joined the CNS / ophthalmology team at Decision Resources Group in 2016. He has authored content for psychiatry and ophthalmology (retinal / nonretinal) indications, including schizophrenia, age-related macular degeneration, diabetic retinopathy / diabetic macular edema, dry eye disease, glaucoma, and uveitis.

Himanshu has more than ten years of experience working in market research and consulting firms, and has managed multiple market assessment projects, including bottom-up forecasts, across multiple therapy areas. He holds a M.S. degree in Pharmacology and Toxicology from the National Institute of Pharmaceutical Education and Research in India and an Executive Post-Graduate Diploma in International Business from the Indian Institute of Foreign Trade.


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