MarketVue®: Geographic Atrophy (GA)
The MarketVue®: Geographic Atrophy market landscape report combines primary (KOL interviews and survey data) and secondary market research to empower strategic decision-making and provide a complete view of the market.Every MarketVue® includes a disease overview, epidemiology (US and EU5), current treatment, unmet needs, pipeline and access and reimbursement chapter.
Topics covered in this report:
• Disease overview: Review the disease pathophysiology and potential druggable targets
• Epidemiology: Understand prevalence, diagnosed and drug-treated prevalence of the population and key market segments
• Current treatment: Understand the treatment decision tree and strengths and weaknesses of current on-label and off-label treatment
• Unmet needs: Identify opportunities to address treatment or disease management gaps
• Pipeline analysis: Compare current and emerging therapy clinical development strategy; their performance on efficacy, safety, and delivery metrics; and their potential to address unmet needs
• Value and access: Review the evidence needed to assess and communicate value to key stakeholders (e.g., providers, payers, regulators) and learn what competitors have done or are doing
Methodology:
Research for the MarketVue®: Geographic Atrophy report is supported by 4 qualitative interviews with key opinion leaders, a quantitative survey with 25 U.S. physicians and secondary research.
Geographies covered:
United States plus epidemiology for EU5 (France, Germany, Italy, Spain, United Kingdom)
Key companies mentioned:
• Apellis Pharmaceuticals
• Astellas Pharma
• Iveric Bio
• Novartis Pharmaceuticals
• Alexion/AstraZeneca
• Alkeus Pharmaceuticals
• Belite Bio
• ONL Therapeutics
• Genentech
• Ionis Pharmaceuticals
• Evergreen Therapeutics
• Janssen
• Aviceda Therapeutics
• Perceive Biotherapeutics
• Cognition Therapeutics
Key drugs mentioned:
• Pegcetacoplan (Syfovre)
• AREDS/AREDS2
• Avacincaptad pegol (Zimura)
• Iptacopan (Fabhalta)
• Danicopan (Voydeya)
• ALK-001
• LBS-008 / Tinlarebant
• ONL1204
• GT005
• IONIS-FB-LRx
• ASP7317
• EG-301
• JNJ-81201887
• AVD-104
• VOY-101
• CT1812
• OpRegen
Key takeaways from the report:
Prior to the approvals of Syfovre and Izervay, the treatment for GA consisted of nonspecific therapies that do not target GA pathophysiology directly (e.g., dietary supplements and surgeries).
Despite the availability of Syfovre for GA and significant number of patients receiving the drug already, interviewed ophthalmologists feel the functional benefit and safety profile of the drug could be improved.
Ophthalmologist, U.S.: “With Syfovre, the vision’s not getting better. In fact, the trials show it gets worse, not because of the drug but because of the natural history of the disease. Unfortunately, you can’t measure improvement on visual acuity but if you did microperimetry you would see that you’re maintaining these patients’ vision, but not improving.”
When asked about what improvements they’d like to see over Syfovre and Izervay, ophthalmologists report they would like to see less frequently administered products with fewer adverse events and treatments able to demonstrate improved functional benefit.
Fortunately for GA patients, the pipeline is full of novel incoming treatment options in development. Ongoing phase 3 trials include:
• Alkeus’ oral chemically modified Vitamin A – ALK-001
• Belite’s oralanti-RBP4– LBS-008
Bayley Koopman, Research Associate at REACH: “While approximately once monthly intravitreal injections represent the current standard of care, orally administered or ‘one-and-done’ treatments such as cell and gene therapies are in development for GA and could potentially reduce the burden of treatment if these therapies are able to demonstrate efficacy.”
Please note: the online download version of this report is for a global site license.
- 1. DISEASE OVERVIEW
- A progressive macular degeneration of the retina characterized by irreversible central vision loss
- Figure 1.1. Risk factors for GA
- Figure 1.2. Physician-reported proportion of their AMD patients that progress to GA
- Disease mechanism
- Figure 1.3. Overactivation of the complement cascade in GA leads to retinal degeneration
- 2. EPIDEMIOLOGY & PATIENT POPULATIONS
- Disease definition
- Figure 2.1. U.S. and EU5 diagnosed prevalent cases of GA by region
- Table 2.1. Prevalent cases of GA in populations aged 50-85 years in the U.S. and EU5
- 3. DIAGNOSIS & CURRENT TREATMENT
- Overview
- Figure 3.1. Referral and treatment pathway for GA
- Physician insights on diagnosis of GA
- Before Syfovre, physicians had no treatment options besides convincing patients to enroll in clinical trials
- Figure 3.2. Current treatment patient share
- Figure 3.3. Evolving treatment goals for GA, pre- and post-Syfovre approval
- Syfovre approval is viewed as a first step in GA management; physicians find efficacy underwhelming
- Figure 3.4. Physician-reported experience/impression of Syfovre
- Overview of Syfovre’s OAKS and DERBY trial data
- Syfovre demonstrates increasing effects over time with accelerated treatment effect between 18-24 months
- Table 3.1. Lesion growth reduction was similar in pts with extrafoveal & subfoveal lesions at 18-24 mos
- Table 3.2. Key insights from OAKS and DERBY trials
- Ophthalmologists’ perspectives on Syfovre
- Physicians report that there are few but significant barriers to Syfovre uptake
- Figure 3.5. Ophthalmologist-reported most impactful barriers to receiving treatment with Syfovre
- Figure 3.6. Percentage of non-prescribers citing reasons for not yet prescribing Syfovre
- Key treatment dynamics that will shape disease management and drug use in GA
- Figure 3.7. Important dynamics of GA market evolution
- 4. UNMET NEED
- Overview
- Figure 4.1. Ophthalmologist-reported unmet needs in GA patients
- Physicians emphasize on the need for txs that not only slow down lesion growth but also provide functional benefit
- 5. PIPELINE ANALYSIS
- Overview
- Figure 5.1. Number of emerging therapies in Ph 3 and Ph 2 addressing key unmet needs in GA
- Figure 5.2. Ophthalmologist-reported most promising mechanisms of action in the pipeline
- GA pipeline is active with several therapies in Ph 2 and 3 development
- Table 5.1. Key Phase 3 trials of drugs in development for GA
- Complement inhibitors and cell/gene therapies dominate the mid-late stage GA pipeline
- Table 5.2. Ongoing key Phase 2 trials of therapies in development for GA
- Complement inhibitors and cell/gene therapies appear to be the future of GA management
- Table 5.2. (contd.) Ongoing key Phase 2 trials of therapies in development for GA
- Astellas Pharmaceutical’s Zimura is poised to compete for GA patient share, if approved
- Figure 5.3. Select results from Phase 3 trials of Zimura in GA patients
- There have been several failures of complement-targeted therapies in clinical development for GA
- Table 5.3. Clinical trial failures of complement-targeted therapies
- Figure 5.4. Physician-reported most meaningful trial outcomes to assess functional benefit
- Physician perspectives on patient selection and outcomes in clinical trials
- 6. VALUE AND ACCESS
- Overview
- Table 6.1. Current pricing of select GA treatments
- Table 6.2. Typical U.S. commercial payer coverage of Syfovre
- Syfovre access and reimbursement dynamics in GA
- Figure 6.1. GA patients by insurance type, U.S.
- Figure 6.2. Figure 6.2. Reimbursement and Access Considerations for Emerging Therapies in GA
- Figure 6.3. Ophthalmologist-reported percentage of patients who have difficulty accessing and/or staying on Syfovre due to insurance restrictions, high OOP costs, or prior authorizations
- 7. METHODOLOGY
- Primary market research approach
- Epidemiology methodology
- Disease definition
- Diagnosed prevalence estimates
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