Dry And Wet Age-Related Macular Degeneration – Unmet Need – Detailed, Expanded Analysis: Wet Age-Related Macular Degeneration (US/EU)
Wet age-related macular degeneration (also known as exudative or neovascular AMD) is characterized by leakage from newly formed blood vessels, distorting the surface of the retina and causing visual impairment. Intravitreal VEGF inhibitors, such as Roche / Genentech / Novartis’s Lucentis, Regeneron/ Bayer HealthCare/ Santen’s Eylea, and Roche / Genentech / Chugai’s Avastin, are the most common pharmacotherapies used to treat wet AMD, owing to their proven efficacy and safety. In November 2021, Roche’s Susvimo launched in the United States, the first refillable permanent implant designed for long-term drug delivery. In 2022, a new therapeutic option, Roche / Chugai’s Vabysmo, launched in the United States, the United Kingdom, and Germany. Vabysmo is a bispecific antibody targeting VEGF and angiopoetin-2 and, as such, represents a novel mechanism of action to treat wet AMD. Additionally, biosimilar versions of ranibizumab launched in July 2022 in the United States and the United Kingdom, potentially addressing the high cost of wet AMD treatment. However, these agents present clinical shortcomings in efficacy, safety, and / or delivery, creating opportunities for new and improved alternatives. Our content examines the key drivers of clinical decision-making in wet AMD and prescriber perceptions of the risk / benefit profiles of available treatments, all of which will help identify levers for new product positioning and differentiation in this space.
QUESTIONS ANSWERED
- What are the treatment drivers and goals for wet AMD?
- What 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 wet AMD?
- What are the prevailing areas of unmet need and opportunity in wet AMD?
- What trade-offs across different clinical attributes and price are acceptable to U.S. and European ophthalmologists for a hypothetical new wet AMD 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, United Kingdom, France, Germany
Primary research: Survey of 60 U.S. and 31 European ophthalmologists fielded in January 2023
Key companies: Roche, Genentech, Regeneron, Novartis, Biogen / Samsung Bioepis, Coherus, Formycon / Bioeq / Teva
Key drugs: Eylea, Lucentis, Beovu, Susvimo, Vabysmo, biosimilar ranibizumab, Avastin
Table of contents
- Dry And Wet Age-Related Macular Degeneration - Unmet Need - Detailed, Expanded Analysis: Wet Age-Related Macular Degeneration (US/EU)
- Executive summary
- Unmet Need - wet age-related macular degeneration - executive summary - March 2023
- Introduction
- Overview
- Methodology
- Rationale for treatment drivers and goals selection
- Rationale for drug selection
- Products for wet AMD 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 wet AMD
- Importance of efficacy attributes to prescribing decisions in wet AMD: United States
- Importance of efficacy attributes to prescribing decisions in wet AMD: Europe
- Importance of safety and tolerability attributes to prescribing decisions in wet AMD: United States
- Importance of safety and tolerability attributes to prescribing decisions in wet AMD: Europe
- Importance of convenience of administration attributes to prescribing decisions in wet AMD: United States
- Importance of convenience of administration attributes to prescribing decisions in wet AMD: 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 wet AMD: United States
- Stated vs. derived importance of key efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to prescribing decisions in wet AMD: Europe
- Product performance against treatment drivers and goals
- Key findings
- Overall performance of key therapies for wet AMD: United States
- Overall performance of key therapies for wet AMD: Europe
- Mean overall performance of key therapies for wet AMD: United States and Europe
- Relative performance of key therapies for wet AMD across select efficacy attributes: United States
- Relative performance of key therapies for wet AMD across select efficacy attributes: Europe
- Relative performance of key therapies for wet AMD across select safety and tolerability attributes: United States
- Relative performance of key therapies for wet AMD across select safety and tolerability attributes: Europe
- Relative performance of key therapies for wet AMD across select convenience of administration attributes: United States
- Relative performance of key therapies for wet AMD across select convenience of administration attributes: Europe
- Assessment of unmet need
- Key findings: unmet need in wet AMD
- Surveyed ophthalmologistsu2019 satisfaction with the performance of key therapies for wet AMD on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: United States
- Surveyed ophthalmologistsu2019 satisfaction with the performance of key therapies for wet AMD on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: Europe
- Surveyed ophthalmologists' ascribed level of unmet need across key efficacy attributes in wet AMD: United States
- Surveyed ophthalmologists' ascribed level of unmet need across key efficacy attributes in wet AMD: Europe
- Surveyed ophthalmologists' ascribed level of unmet need across key safety and tolerability attributes in wet AMD: United States
- Surveyed ophthalmologists' ascribed level of unmet need across key safety and tolerability attributes in wet AMD: Europe
- Surveyed ophthalmologists' ascribed level of unmet need across key convenience of administration attributes in wet AMD: United States
- Surveyed ophthalmologists' ascribed level of unmet need across key convenience of administration attributes in wet AMD: Europe
- Key findings: unmet need in wet AMD and related indications
- Surveyed ophthalmologists' ascribed level of unmet need in wet AMD and related indications: United States
- Surveyed ophthalmologists' ascribed level of unmet need in wet AMD and related indications: Europe
- Opportunity analysis
- Areas of opportunity in the wet AMD market and emerging therapy insights
- Opportunity: a new wet AMD therapy with more-convenient delivery profile
- Opportunity: a novel therapy that is effective in improving visual acuity in a higher percentage of wet AMD patients
- Areas of opportunity in the wet AMD 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 late-phase emerging therapies for wet AMD
- Attribute importance and part-worth utilities
- Wet AMD target product profile: attribute importance
- Mean change in BCVA on the ETDRS from baseline at 12 months
- Percentage of patients with u2265 15 letter gain from baseline BCVA at 12 months
- Percentage of patients with absence of SRF / IRF at 12 months
- Rate of serious ocular side effects (e.g., endophthalmitis, vasculitis) at 12 months
- Rate of serious non-ocular side effects (e.g., APTC-defined ATEs) at 12 months
- Delivery profile
- Price per year
- Conjoint analysis-based simulation of a market scenario
- Wet AMD market simulation: share of preference of target product profiles included in the market scenario
- Wet AMD market simulation: likelihood to prescribe of target product profiles included in the market scenario
- Wet AMD market simulation: target product profiles included in the market scenario
- Appendix
- Key abbreviations
- Bibliography
- Executive summary
Amanda Le, M.S., Healthcare Research & Data Analyst, CNS and Ophthalmology. Prior to joining the company, she worked on research projects focusing on the effects of aging on the development of oral premalignancies, head and neck cancers, and handedness in surgery. She holds a master’s degree in medical sciences from Boston University School of Medicine and a bachelor’s degree in biochemistry from Boston College.
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.