Dry And Wet Age-Related Macular Degeneration – Unmet Need – Detailed, Expanded Analysis: Geographic Atrophy (US/EU)
Geographic atrophy (GA), an advanced form of dry age-related macular degeneration (AMD), is a leading cause of visual impairment and blindness in the United States and Europe. Degradation of cells in the retinal pigment epithelium under the retina and the related atrophy of macular photoreceptors are characteristics of GA. Eye-specific AREDS vitamin and mineral supplements are often recommended to GA patients even though they have not been shown to be effective in reducing GA progression specifically. In February 2023, the first approved pharmacotherapy for GA launched in the United States—Apellis Pharmaceuticals’ Syfovre (pegcetacoplan). In August 2023, Astellas / Iveric Bio’s Izervay (avacincaptad pegol, formerly Zimura) launched for GA in the United States. These therapies have clinical shortcomings in terms of efficacy, safety, and/or delivery, creating opportunities for new and improved alternatives; indeed, the GA pipeline is replete with agents progressing to later stages of development. Our content examines the key treatment drivers, the areas of greatest unmet need, and prescriber perceptions of the risk / benefit profiles of the two GA treatments.
QUESTIONS ANSWERED
- What are the treatment drivers and goals for GA?
- Which drug attributes are key influences, which have limited impact, and which are hidden opportunities?
- How do current therapies perform on key treatment drivers and goals for GA?
- What are the prevailing areas of unmet need and opportunity in GA?
- What trade-offs across different clinical attributes and price are acceptable to U.S. and European ophthalmologists for a hypothetical new GA drug?
PRODUCT DESCRIPTION
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, France, Germany, United Kingdom
Primary research: Survey of 60 U.S. and 30 European ophthalmologists fielded in June 2023
Key companies: Apellis Pharmaceuticals, Astellas, Iveric Bio
Key drugs: Syfovre, Izervay (N.B., Izervay was not launched at the time of survey fielding), AREDS1 and AREDS 2 supplements
Table of contents
- Dry And Wet Age-Related Macular Degeneration - Unmet Need - Detailed, Expanded Analysis: Geographic Atrophy (US/EU)
- Executive Summary
- Unmet Need - Geographic Atrophy - Executive Summary - September 2023
- Introduction
- Overview
- Methodology
- Rationale for treatment drivers and goals selection
- Rationale for drug selection
- Products for GA 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 GA
- Importance of efficacy attributes to prescribing decisions in GA: United States
- Importance of efficacy attributes to prescribing decisions in GA: Europe
- Importance of safety and tolerability attributes to prescribing decisions in GA: United States
- Importance of safety and tolerability attributes to prescribing decisions in GA: Europe
- Importance of convenience of administration attributes to prescribing decisions in GA: United States
- Importance of convenience of administration attributes to prescribing decisions in GA: Europe
- Importance of nonclinical factors to prescribing decisions in GA: United States
- Importance of nonclinical factors to prescribing decisions in GA: 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 GA United States
- Stated vs. derived importance of key efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to prescribing decisions in GA: Europe
- Product performance against treatment drivers and goals
- Key findings
- Overall performance of key therapies for GA: United States
- Overall performance of key therapies for GA: Europe
- Mean overall performance of key therapies for GA: United States and Europe
- Relative performance of key therapies for GA across select efficacy attributes: United States
- Relative performance of key therapies for GA across select efficacy attributes: Europe
- Relative performance of key therapies for GA across select safety and tolerability attributes: United States
- Relative performance of key therapies for GA across select safety and tolerability attributes: Europe
- Relative performance of key therapies for GA across select convenience of administration attributes: United States
- Relative performance of key therapies for GA across select convenience of administration attributes: Europe
- Relative performance of key therapies for GA across select nonclinical attributes: United States
- Relative performance of key therapies for GA across select nonclinical attributes: Europe
- Assessment of unmet need
- Key findings: unmet need in GA
- Surveyed ophthalmologistsu2019 satisfaction with the performance of key therapies for GA on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: United States
- Surveyed ophthalmologistsu2019 satisfaction with the performance of key therapies for GA on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: Europe
- Surveyed ophthalmologists' ascribed level of unmet need across key efficacy attributes in GA: United States
- Surveyed ophthalmologists' ascribed level of unmet need across key efficacy attributes in GA: Europe
- Surveyed ophthalmologists' ascribed level of unmet need across key safety and tolerability attributes in GA: United States
- Surveyed ophthalmologists' ascribed level of unmet need across key safety and tolerability attributes in GA: Europe
- Surveyed ophthalmologists' ascribed level of unmet need across key convenience of administration attributes in GA: United States
- Surveyed ophthalmologists' ascribed level of unmet need across key convenience of administration attributes in GA: Europe
- Surveyed ophthalmologists' ascribed level of unmet need across key nonclinical factors in GA: United States
- Surveyed ophthalmologists' ascribed level of unmet need across key nonclinical factors in GA: Europe
- Key findings: unmet need in GA and related indications
- Surveyed ophthalmologists' ascribed level of unmet need in GA and related indications: United States
- Surveyed ophthalmologists' ascribed level of unmet need in GA and related indications: Europe
- Opportunity analysis
- Areas of opportunity in the GA market and emerging therapy insights
- Opportunity: a novel agent that reduces GA lesion growth
- Opportunity: a therapy with a lower risk of serious ocular side effects
- Opportunity: a novel agent with a lower incidence of new-onset exudative AMD
- Areas of opportunity in the GA market and emerging therapy insights
- Target product profiles
- Assessing drug development opportunities
- Target product profile methodology
- Attributes and attribute levels
- Attribute importance and part-worth utilities
- GA target product profile: attribute importance
- Reduction in GA area growth from baseline at two years relative to placebo
- Mean change from baseline in BCVA at two years
- Effect on vision-related quality of life
- Incidence of serious ocular adverse events at two years
- Incidence of new-onset exudative AMD at two years
- Delivery profile
- Price per year
- Conjoint analysis-based simulation of a market scenario
- GA market simulation: share of preference of target product profiles included in the market scenario
- GA market simulation: likelihood to prescribe of target product profiles included in the market scenario
- GA market simulation: target product profiles included in the market scenario
- Appendix
- Key abbreviations
- Bibliography
- Executive Summary
Andrea S. Witt, Ph.D., is Director 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.