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Aflibercept · 2 trials · 1 indication
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (\<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment. An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. Invalid BCVA values were excluded. 97.5% CI is a rounding of 97.52% CI.
| Arm | Type | Description |
|---|---|---|
| A: Faricimab 6 mg Q8W | EXPERIMENTAL | Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100. |
| B: Faricimab 6 mg PTI | EXPERIMENTAL | Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100. |
| C: Aflibercept 2 mg Q8W | ACTIVE_COMPARATOR | Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100. |
| Name | Type | Description |
|---|---|---|
| Aflibercept | DRUG | Aflibercept 2 mg was administered by intravitreal (IVT) injection into the study eye once every 8 weeks (Q8W). |
| Faricimab | DRUG | Faricimab 6 mg was administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or according to a personalized treatment interval (PTI) in arm B. |
| Sham Procedure | PROCEDURE | The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It was administered to participants in all three treatments arms at applicable visits to maintain masking among treatment arms. |
Inclusion Criteria: * Documented diagnosis of diabetes mellitus (Type 1 or Type 2) * Hemoglobin A1c (HbA1c) of less than or equal to (≤)10% within 2 months prior to Day 1 * Macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea * Decreased visual acuity attri...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901, Aflibercept |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Oculis Holding AG | OCS | 2 | PHASE3 | Dexamethasone, Vehicle |
| AbbVie, Inc. | ABBV | 3 | PHASE2 | ABBV-RGX-314 Dose 1, Steroid, Aflibercept |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | bevacizumab |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-150 IVT, Aflibercept IVT |
| Alvotech | ALVO | 1 | PHASE3 | AVT29, Eylea HD |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 Dose 1, RGX-314 Dose 2, Aflibercept |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
Aflibercept is an investigational small molecule being studied for the treatment of Diabetic Macular Edema, a condition that causes vision loss due to fluid buildup in the macula. It is currently in Phase 3 clinical development, though the trials listed for this asset have been completed.
Aflibercept is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting late-stage clinical research on this drug for Diabetic Macular Edema.
Aflibercept is in Phase 3 clinical development for Diabetic Macular Edema. The two Phase 3 trials associated with this drug have been completed, and it remains an investigational agent, not yet approved for any use.
Aflibercept has been studied in two completed Phase 3 trials: NCT03622580, which enrolled 940 participants, and NCT03622593, which enrolled 951 participants. Both trials were randomized, double-blind, and active-controlled, and both evaluated the drug in patients with Diabetic Macular Edema.
Aflibercept is also known as Faricimab, with the code name RO6867461. The clinical trials for this drug, including NCT03622580 and NCT03622593, refer to it as Faricimab (RO6867461) in their titles.