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Izervay (AVACINCAPTAD PEGOL)
Izervay works by binding to and inhibiting the activity of Complement C5, a protein involved in the immune response.
Izervay, a complement C5 inhibitor developed by Astellas Pharma, is currently marketed for the treatment of geographic atrophy secondary to AMD. Its key strength lies in its mechanism of action, which directly targets the complement C5 protein, a critical component of the immune response implicated in the progression of GA. The primary risk to Izervay's market position is the presence of several competitors targeting the same pathway, including eculizumab, pozelimab, and off-patent drugs like oxaprozin and raloxifene.
At a glance
| Generic name | AVACINCAPTAD PEGOL |
|---|---|
| Sponsor | Astellas Pharma |
| Target | Complement C5 |
| Modality | Oligonucleotide |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2023 |
Mechanism of action
Avacincaptad pegol is an RNA aptamer, PEGylated oligonucleotide that binds to and inhibits complement protein C5. By inhibiting C5, avacincaptad pegol may prevent its cleavage to C5a and C5b thus decreasing membrane attack complex (MAC) formation.
Approved indications
- Geographic atrophy (GA) secondary to AMD
Common side effects
- Conjunctival hemorrhage
- Increased IOP
- Blurred vision
- Choroidal neovascularization
- Eye pain
- Vitreous floaters
- Blepharitis
Key clinical trials
- Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy (PHASE3)
- Zimura Compared to Sham in Patients With Autosomal Recessive Stargardt Disease (STGD1) (PHASE2)
- A Study to Investigate Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Immunogenicity of RO7669330 in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) (PHASE1)
- A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy
- A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration (PHASE4)
- Study to Evaluate Efficacy and Safety of ONL1204 in Patients With GA Associated With AMD (PHASE2)
- A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor) (PHASE3)
- ZIMURA in Combination With LUCENTIS in Patients With Neovascular Age Related Macular Degeneration (NVAMD) (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Izervay CI brief — competitive landscape report
- Izervay updates RSS · CI watch RSS
- Astellas Pharma portfolio CI