Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 clinical development for ophthalmology indications, including neovascular (wet) age-related macular degeneration and chorioretinal vascular disease. It is being developed by Amgen Inc. (ticker AMGN) and is studied as a potential treatment for retinal vascular conditions.
ABP 938 is being studied for the treatment of neovascular (wet) age-related macular degeneration, a retinal condition involving abnormal blood vessel growth. It is also being evaluated in chorioretinal vascular disease. The drug remains investigational and has not been established as a marketed therapy for these indications.
ABP 938 is developed by Amgen Inc., which trades under the ticker AMGN. Amgen is running the clinical program, including Phase 3 studies in neovascular age-related macular degeneration and chorioretinal vascular disease.
ABP 938 is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The program includes completed and recruiting Phase 3 trials in retinal vascular diseases, with total reported enrollment across studies of 576 participants in the completed neovascular AMD trial and additional participants in other studies.
ABP 938 has been studied in Phase 3 trials including NCT04270747 in neovascular (wet) age-related macular degeneration, NCT05704725 in chorioretinal vascular disease, and the recruiting trial NCT07614776 comparing ABP 938 8 mg with EYLEA HD (aflibercept) in neovascular AMD across the United States, Europe, and Asia.