Overview
Avacincaptad pegol is an RNA aptamer covalently bound to a branched polyethylene glycol (PEG) molecule. It was developed to treat an advanced form of age-related macular degeneration (AMD) called geographic atrophy (GA). AMD is the leading cause of vision loss in developed countries for people over 50 years old, with a global estimate of 170 million individuals affected. AMD eventually progresses to bilateral and irreversible loss of vision, whether or not the patients have the non-neovascular (dry) or the neovascular (wet) form of AMD. Although anti-VEGF therapy is available for the neovascular form of AMD, no treatment was approved for GA. Avacincaptag pegol was approved by the FDA on August 4, 2023, under the brand name IZERVAY for the treatment of GA secondary to AMD. This approval is based on the positive results obtained from 2 phase 3 clinical trials GATHER1 and GATHER2.
Background
Avacincaptad pegol is an RNA aptamer covalently bound to a branched polyethylene glycol (PEG) molecule. It was developed to treat an advanced form of age-related macular degeneration (AMD) called geographic atrophy (GA). AMD is the leading cause of vision loss in developed countries for people over 50 years old, with a global estimate of 170 million individuals affected. AMD eventually progresses to bilateral and irreversible loss of vision, whether or not the patients have the non-neovascular (dry) or the neovascular (wet) form of AMD. Although anti-VEGF therapy is available for the neovascular form of AMD, no treatment was approved for GA. Avacincaptag pegol was approved by the FDA on August 4, 2023, under the brand name IZERVAY for the treatment of GA secondary to AMD. This approval is based on the positive results obtained from 2 phase 3 clinical trials GATHER1 and GATHER2.
Indication
Avacincaptad pegol is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Associated Conditions
- Dry Macular Degeneration
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/14 | Phase 3 | Recruiting | |||
2022/10/07 | Phase 2 | Terminated | |||
2022/09/10 | Phase 3 | Completed | |||
2020/06/17 | Phase 3 | Completed | |||
2017/12/15 | Phase 2 | Withdrawn | Ophthotech Corporation | ||
2017/12/06 | Phase 2 | Completed | |||
2017/12/05 | Phase 2 | Completed | Ophthotech Corporation | ||
2016/02/19 | Phase 2 | Completed | |||
2015/03/25 | Phase 2 | Completed | Ophthotech Corporation | ||
2009/08/03 | Phase 1 | Completed | Ophthotech Corporation |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Astellas Pharma US, Inc. | 82829-002 | INTRAVITREAL | 20 mg in 1 mL | 12/11/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||