| Product Name | Brolucizumab ELISA Kit |
|---|---|
| Synonyms | ESBA-1008, ESBA1008, RTH258, CAS: 1531589-13-5 |
| Method | Quantitative |
| Detection Range | 1.5625 ng/mL — 100 ng/mL |
| Sample Types | Plasma, Serum |
| Reconstitution | Detection method: Colorimetric. Recovery: 80-120%. Specifications: Brolucizumab |
| Storage | The stability of ELISA kit is determined by the loss rate of activity. The loss rate of this kit is less than 10% prior to the expiration date under appropriate storage condition. |
| Notes | Detection method: Colorimetric. Recovery: 80-120% |
| Background | Brolucizumab is the first and only single-chain variable fragment (scFv) targeting vascular endothelial growth factor (VEGF)-A. It has a smaller molecular weight (26 kDa). The mAb is undergoing evaluation as a treatment for neovascular age-related macular degeneration (nAMD). In June 2017, Novartis announced that the primary efficacy endpoint of non-inferiority to aflibercept (EYLEA®) in mean change in best-corrected visual acuity from baseline to week 48 was met in the Phase 3 HAWK (NCT02307682) and HARRIER (NCT02434328) studies, which included more than 1,800 patients. The two studies compared the efficacy and safety of intravitreal injections of 6 mg brolucizumab or 3 mg brolucizumab (HAWK study only) versus 2 mg aflibercept in patients with nAMD. Of patients receiving 6 mg brolucizumab, 57% (HAWK) and 52% (HARRIER) were maintained exclusively on an every 12 week dosing interval immediately following the loading phase and continuing through week 48.54 Key secondary endpoints were also met. Novartis is developing a competitive, low cost of goods formulation, and expects to complete the PK study with antibody derived from the final manufacturing process to enable filing in 2018. |
| Supplier | ARP |
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