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Label indication PAVBLU is indicated for the treatment of: PAVBLU is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) ( 1.1 ) Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.2 ) Diabetic Macular Edema (DME) ( 1.3 ) Diabetic Retinopathy (DR) ( 1.4 ) 1.1 Neovascular (Wet) Age-Related Macular Degeneration (AMD) 1.2… FDA label
Also known as PAVBLU™
ABP 938 · 3 trials · 4 indications
A successful injection was defined by whether the retinal specialist administering the IVT injection answered 'yes' to the following question: Did the PFS allow for the safe and effective administration of the prescribed dose? Percentage of successful injections and Clopper-Pearson 95% Confidence Interval is reported.
BCVA score was assessed based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart by the study eye at 4 meters. ETDRS letters score could range from 0 to 100 letters at each assessment. A positive change from Baseline in ETDRS letter score indicated an improvement in visual acuity in the study eye. Change from Baseline calculated as observed post-baseline value - Baseline value.
| Arm | Type | Description |
|---|---|---|
| ABP 938 8 mg | EXPERIMENTAL | Participants will receive intravitreal ABP 938 8 mg injections at Baseline, Week 4, and Week 8. Participants will then be assessed at scheduled study visits, with Dose Regimen Adjustment (DRA) decisions beginning at Week 16 based on predefined disease-activity criteria. Injections will be administered at protocol-defined intervals ranging from every 4 to 16 weeks through the end of the study. |
| Aflibercept (US) 8 mg | ACTIVE_COMPARATOR | Participants will receive intravitreal Aflibercept (US) 8 mg injections at Baseline, Week 4, and Week 8. Participants will then be assessed at scheduled study visits, with DRA decisions beginning at Week 16 based on predefined disease-activity criteria. Injections will be administered at protocol-defined intervals ranging from every 4 to 16 weeks through the end of the study. |
| ABP 938 | EXPERIMENTAL | Participants will be randomized in a ratio of 2:1 to receive either a single IVT injection of ABP 938 in a PFS or a single injection of aflibercept in a PFS. |
| Aflibercept | EXPERIMENTAL | Participants will be randomized in a ratio of 2:1 to receive either a single IVT injection of ABP 938 in a PFS or a single injection of aflibercept in a PFS. |
| ABP 938-Treatment Group A | EXPERIMENTAL | Subjects will receive 2 mg (0.05 mL) of ABP 938 by intravitreal (IVT) injection every 4 weeks for the first 3 doses (ie, baseline/day 1, week 4, and week 8) and every 8 weeks from week 16 until week 48. |
| Aflibercept-Treatment Group B1 | ACTIVE_COMPARATOR | Subjects will receive 2 mg (0.05 mL) of aflibercept (Treatment Group B) by IVT injection every 4 weeks for the first 3 doses (ie, baseline/day 1, week 4, and week 8). Subjects will be re-randomized to receive aflibercept by IVT injection every 8 weeks from week 16 until week 48. |
| ABP 938-Treatment group B2 | ACTIVE_COMPARATOR | Subjects will receive 2 mg (0.05 mL) of aflibercept (Treatment Group B) by IVT injection every 4 weeks for the first 3 doses (ie, baseline/day 1, week 4, and week 8). Subjects will be re-randomized to receive ABP 938 by IVT injection every 8 weeks from week 16 until week 48 |
| Name | Type | Description |
|---|---|---|
| ABP 938 8 mg | DRUG | IVT injection |
| Aflibercept (US) 8 mg | DRUG | IVT injection |
| ABP 938 | DRUG | IVT injection |
| Aflibercept | DRUG | IVT injection |
Inclusion Criteria: * Men or women ≥ 50 years old, capable of giving signed informed consent * Active, treatment-naïve subfoveal CNV lesions secondary to nAMD including juxtafoveal lesions that affect the fovea as confirmed by SD-OCT and FA in the study eye (SE) * Total area of CNV (including both ...
ABP 938 is an investigational small molecule in Phase 3 development by Amgen Inc. (ticker AMGN) for ophthalmology indications. It is being studied in chorioretinal vascular disease and neovascular (wet) age-related macular degeneration. It is not yet approved and remains in clinical development.
ABP 938 is being evaluated for the treatment of neovascular (wet) age-related macular degeneration, or nAMD, a form of chorioretinal vascular disease. Phase 3 studies compare ABP 938 8 mg with EYLEA HD (aflibercept) in participants with nAMD. It is investigational and not approved for this use.
ABP 938 is developed by Amgen Inc., which trades on Nasdaq under the ticker AMGN. Amgen is running the Phase 3 clinical program evaluating ABP 938 in chorioretinal vascular disease and neovascular age-related macular degeneration.
ABP 938 is in Phase 3 clinical development. Three Phase 3 studies have been registered: one completed study in chorioretinal vascular disease, one completed study in neovascular (wet) age-related macular degeneration, and one recruiting study in nAMD. ABP 938 is investigational and has not been approved.
ABP 938 has been studied in Phase 3 trials NCT04270747 in neovascular (wet) age-related macular degeneration, NCT05704725 in chorioretinal vascular disease, and NCT07614776, a recruiting Phase 3 study comparing ABP 938 8 mg with EYLEA HD (aflibercept) in nAMD. The nAMD study NCT04270747 enrolled 576 participants.