Drugs / Avacincaptad Pegol
Avacincaptad Pegol
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn diffuse secondary choroid atrophy 4 milestones | |||||
| Filed | US (FDA) | IZERVAY | diffuse secondary choroid atrophy | 2025-01-06 | “FDA accepted the revised supplemental New Drug Application (sNDA) for IZERVAY TM” astellas.com ↗ |
| Withdrawn | EU (EMA) | — | diffuse secondary choroid atrophy | 2024-10-28 | “today announced the company's decision to withdraw its marketing authorization application from the European Medicines Agency (EMA) for avacincaptad pegol intravitreal solution (ACP)” astellas.com ↗ |
| Filed | US (FDA) | IZERVAY | diffuse secondary choroid atrophy | 2024-04-01 | “U.S. FDA Accepts Astellas’ Supplemental New Drug Application for IZERVAY TM (avacincaptad pegol intravitreal solution) for Geographic Atrophy” astellas.com ↗ |
| Filed | EU (EMA) | — | diffuse secondary choroid atrophy | 2023-08-18 | “the European Medicines Agency (EMA) has accepted for regulatory review the marketing authorization application (MAA) for avacincaptad pegol (ACP)” astellas.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Label expansion | US (FDA) | IZERVAY | — | 2025-02-12 | fda.gov ↗ |
| Approved | US (FDA) | IZERVAY | — | 2023-08-04 | fda.gov ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06961370 | Jul 2025 → Jan 2027 expected | age-related macular degeneration, diffuse secondary choroid atrophy | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 1 | NCT00709527 | Oct 2008 → Dec 2009 | wet macular degeneration | Ophthotech Corporation | Completed | No outcome recorded |
| Phase 25 trials · 1 missed | ||||||
| Phase 2 | NCT03374670 | Nov 2018 → Dec 2019 | — | Ophthotech Corporation | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03364153 | Jan 2018 → Mar 2025 | Stargardt disease | Astellas Pharma Global Development, Inc. | Completed | Missed primary |
| Phase 2 | NCT03362190 | Oct 2017 → Oct 2018 | wet macular degeneration | Ophthotech Corporation | Completed | No outcome recorded |
| Phase 2 | NCT05571267 | Oct 2016 → Apr 2018 | wet macular degeneration | IVERIC bio, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02397954 | Mar → Oct 2015 | — | Ophthotech Corporation | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT02686658 | Dec 2015 → Sep 2019 | diffuse secondary choroid atrophy, dry age related macular degeneration | IVERIC bio, Inc. | Completed | Met primary |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT05536297 | Sep 2022 → Apr 2025 | age-related macular degeneration, diffuse secondary choroid atrophy | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04435366 | Jun 2020 → Jul 2022 | age-related macular degeneration, diffuse secondary choroid atrophy | IVERIC bio, Inc. | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT06970665 | Jul 2025 → Jun 2027 expected | age-related macular degeneration, diffuse secondary choroid atrophy | Astellas Pharma Inc | Active not recruiting | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT00950638 Comparator | Jul 2009 → Mar 2011 | dry age related macular degeneration | Ophthotech Corporation | Completed | No outcome recorded |
| Phase 2 | NCT06659445 Comparator | Oct 2025 → Nov 2028 expected | dry age related macular degeneration | ONL Therapeutics | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2026-05-14 | Astellas Pharma Inc | Regulatory China’s National Medical Products Administration Accepts New Drug Application for IZERVAY™ (avacincaptad pegol) for the Treatment of Geographic Atrophy Secondary to Age-Related Macular Degeneration astellas.com ↗
ACP has also been granted Priority Review status in China. |
| 2026-05-12 | Astellas Pharma Inc | Results IZERVAY® (avacincaptad pegol intravitreal solution) Demonstrated Increased Probability of Maintaining Driving Eligibility in Geographic Atrophy Patients astellas.com ↗
At 24 months, the risk of progressing to loss of driving eligibility was 12.6% for IZERVAY monthly (EM) or every-other-month (EOM) compared to 20.1% for sham, representing a 41% relative risk reduction for IZERVAY (nominal p-value=0.0594) |
| 2025-10-19 | Astellas Pharma Inc | Results IZERVAY™ (avacincaptad pegol intravitreal solution) Showed Increased Benefit in Reducing Geographic Atrophy Progression Over Time and Consistent Long-Term Safety astellas.com ↗
Study results found no new safety signals and no cases of retinal vasculitis or occlusive vasculitis after IZERVAY treatment of up to 3.5 years |
| 2025-09-19 | Astellas Pharma Inc | Regulatory Astellas Receives Conditional Approval for IZERVAY, making it the first and only approved treatment for the Suppression of Geographic Atrophy Growth in Japan astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted Conditional Approval of IZERVAY (avacincaptad pegol intravitreal solution: ACP) for the suppression of geographic atrophy (GA) growth in atrophic age-related macular degeneration (AMD). |
| 2025-02-13 | Astellas Pharma Inc | Regulatory U.S. FDA Approves Expanded Label for Astellas’ IZERVAY TM (avacincaptad pegol intravitreal solution) for Geographic Atrophy astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the U.S. Food and Drug Administration (FDA) approved expanded U.S. Prescribing information for IZERVAY TM (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). |
| 2025-02-05 | Astellas Pharma Inc | Regulatory Astellas Submits New Drug Application for Conditional Approval of Avacincaptad Pegol for Geographic Atrophy in Japan astellas.com ↗
Today’s submission comes as good news to people in Japan living with geographic atrophy who have no approved treatment options for this devastating disease. |
| 2025-01-24 | Astellas Pharma Inc | Regulatory Notice Regarding Progress in Core Business, Impairment Loss and Revision of Financial Forecasts for FY2024 astellas.com ↗
As a result of the withdrawal of the marketing authorization application for IZERVAY™ (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy secondary to age-related macular degeneration in Europe |
| 2025-01-09 | Astellas Pharma Inc | Regulatory U.S. FDA Confirms Class 1 Resubmission of the Supplemental New Drug Application for IZERVAY TM (avacincaptad pegol intravitreal solution) for Geographic Atrophy astellas.com ↗
The application was refiled following a December 20, 2024, meeting between the FDA and Astellas and has been designated as a Class 1 resubmission, with a 60-day review period. |
| 2024-11-19 | Astellas Pharma Inc | Regulatory Astellas Provides Update on IZERVAY TM (avacincaptad pegol intravitreal solution) Supplemental New Drug Application astellas.com ↗
The FDA stated the agency cannot approve the sNDA in its present form by the Prescription Drug User Fee Act (PDUFA) action date of November 19, 2024. |
| 2024-10-28 | Astellas Pharma Inc | Regulatory Astellas Provides Update on Marketing Authorization Application for Avacincaptad Pegol (ACP) in the European Union astellas.com ↗
The company's decision to withdraw its application followed interactions with the EMA’s Committee for Medicinal Products for Human Use (CHMP). |
| 2024-04-01 | Astellas Pharma Inc | Regulatory U.S. FDA Accepts Astellas’ Supplemental New Drug Application for IZERVAY TM (avacincaptad pegol intravitreal solution) for Geographic Atrophy astellas.com ↗ |
| 2023-11-04 | Astellas Pharma Inc | Results IZERVAY TM (avacincaptad pegol intravitreal solution) Monthly or Every Other Month Reduced Geographic Atrophy Lesion Growth Through 2 Years astellas.com ↗
IZERVAY dosed EM through 2 years demonstrated a statistically significant year-over-year reduction of 14% in the mean rate of GA growth at 2 years from baseline vs. sham (p=0.0165), the primary objective of the year 2 analyses from GATHER2. |
| 2023-09-18 | Astellas Pharma Inc | Results Iveric Bio Announces Positive 24-Month Topline Results from Phase 3 Study of IZERVAY TM (avacincaptad pegol intravitreal solution) for Geographic Atrophy astellas.com ↗
Topline results demonstrated that the IZERVAY monthly dosing regimen met the primary objective to significantly slow GA growth compared to sham at 24 months. |
| 2023-08-18 | Astellas Pharma Inc | Regulatory European Medicines Agency Accepts Iveric Bio’s Marketing Authorization Application for Avacincaptad Pegol for Geographic Atrophy astellas.com ↗
This acceptance of our EU Marketing Authorization Application is a key milestone in our global effort to help patients living with GA, a leading cause of blindness worldwide. |
| 2023-08-05 | Astellas Pharma Inc | Regulatory Iveric Bio Receives U.S. FDA Approval for IZERVAY TM (avacincaptad pegol intravitreal solution), a New Treatment for Geographic Atrophy astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”), today announced the U.S. Food and Drug Administration (FDA) approved IZERVAY TM (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) on August 4, 2023. |
All press releases naming this drug 17 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | avacincaptad pegol | “Drug: Avacincaptad Pegol” NCT05571267 ↗ |
| Known as | Izervay | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06961370 ↗ |
| Known as | Zimura | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03374670 ↗ |
| Action | Inhibit | “Zimura™ (Anti-C5 Aptamer)” NCT02397954 ↗ |
| Modality | Aptamer | “Zimura™ (Anti-C5 Aptamer)” NCT02397954 ↗ |
| Route | Intravitreal | “monthly intravitreous injections” NCT02397954 ↗ |
| Target | C5 | “Zimura™ (Anti-C5 Aptamer)” NCT02397954 ↗ |