NDAINTRAVITREALSOLUTIONPriority Review
Approved
Aug 2023
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
11
Data completeness
5/8 — Partial
Priority Review
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IZERVAY (avacincaptad pegol) is a small-molecule intravitreal solution approved in August 2023 for retinal degenerative diseases including geographic atrophy, age-related macular degeneration, idiopathic polypoidal choroidal vasculopathy, and Stargardt macular dystrophy. The drug's mechanism of action targets complement-mediated retinal damage, addressing a critical unmet need in vision-threatening eye conditions. Astellas' intravitreal delivery approach enables direct ocular targeting with minimal systemic exposure.
$0.216MPart D
Growth8.2 years to LOEEarly-stage growth product with modest Medicare claims volume but significant market potential in large retinal disease patient population; small but expanding commercial team.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (11)
A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration
Started Jul 2025
20 enrolled
Geographic AtrophyAge-Related Macular Degeneration
A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy
Started Jan 2025
1,000 enrolled
Geographic AtrophyMacular Degeneration
Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy
Started Sep 2022
278 enrolled
Geographic AtrophyAge-Related Macular Degeneration
A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)
Started Jun 2020
448 enrolled
Geographic AtrophyMacular Degeneration
Zimura Compared to Sham in Patients With Autosomal Recessive Stargardt Disease (STGD1)
Started Jan 2018
121 enrolled
Stargardt's Macular Dystrophy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.