Approval Probability
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SOK583A1 · 3 trials · 2 indications
Number of participants with ocular treatment emergent adverse events were reported.
Number of participants with non-ocular treatment emergent adverse events were reported.
The primary aim of the study is to demonstrate equivalence of change in BCVA score from Baseline at Week 8 between participants with nAMD treated with SOK583A1 and participants treated with Eylea EU. The primary analysis will be performed on the Per-Protocol Set (PPS), which is the most appropriate analysis set to use when testing for equivalence. ETDRS: Early Treatment Diabetic Retinopathy Study EU: European
| Arm | Type | Description |
|---|---|---|
| SOK583A1 | EXPERIMENTAL | SOK583A1 will be provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL) |
| SOK583A1 (40 mg/mL) | EXPERIMENTAL | participants received a single dose of 2 mg SOK583 in 0.05 mL (40 mg/mL) and completed the study |
| Eylea EU (40 mg/mL) | ACTIVE_COMPARATOR | IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48. EU: European |
| Name | Type | Description |
|---|---|---|
| SOK583A1 | DRUG | SOK583A1 will be provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL) |
| SOK583A1 (40 mg/mL) | DRUG | SOK583A1 provided in a Prefilled Syringe (PFS), which includes 2 mg aflibercept in 0.05 mL for IVT administration |
| Prefilled Syringe (PFS) | DEVICE | Prefilled Syringe (PFS) |
| Eylea EU (40 mg/mL) | BIOLOGICAL | IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48. |
Inclusion Criteria: * Patients ≥ 50 years of age at baseline * Patients diagnosed with nAMD (uni- or bilateral) * Patients already under IVT Eylea treatment (last injection of the induction period or maintenance phase) * Willing and able to comply with all study procedures, and be likely to complet...
SOK583A1 is an investigational monoclonal antibody being developed for the treatment of neovascular age-related macular degeneration (nAMD), a condition that causes vision loss due to abnormal blood vessel growth in the eye. It is administered via intravitreal injection and is currently in Phase 3 clinical development.
SOK583A1 is being developed by Novartis AG (ticker: NVS), a global pharmaceutical company. The drug is in Phase 3 clinical trials for neovascular age-related macular degeneration, with studies conducted in multiple countries including the United States, Japan, and several European nations.
SOK583A1 is in Phase 3 clinical development. It is an investigational drug, not yet approved by regulatory authorities. Two Phase 3 trials have been completed, including a large efficacy study and two smaller safety studies focused on different delivery methods.
SOK583A1 has been studied in three completed Phase 3 trials. The main efficacy trial, NCT04864834, compared SOK583A1 to Eylea in 485 patients with nAMD. Two additional safety studies, NCT05161806 and NCT05282004, evaluated the drug in prefilled syringes and vial kits, respectively.
In the Phase 3 trial NCT04864834, SOK583A1 was compared directly against Eylea (aflibercept) in 485 patients with neovascular age-related macular degeneration. The study was randomized, double-blind, and active-controlled, meaning patients received either SOK583A1 or the comparator Eylea to assess efficacy, safety, and immunogenicity.
No, SOK583A1 is not the same as Eylea. SOK583A1 is a separate investigational monoclonal antibody developed by Novartis, while Eylea is a different approved treatment for nAMD. In clinical trials, SOK583A1 has been tested against Eylea as an active comparator to evaluate its relative efficacy and safety.