Phase 3 (BLA Filing)
Amp Volatility Score
Catalyst Info & Data Links
TITLE: Lucentis® (ranibizumab) Biosimilar in Ophthalmology (anti-VEGF) - BLA Filing
WHAT IS THE CATALYST EVENT?
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
01-2020: 38th Annual J.P. Morgan Global Healthcare Conference (slides 11, 12, 21, 23, 24, 29)
MECHANISM OF ACTION / RATIONALE
Ranibizumab binds to the receptor binding site of active forms of VEGF-A, including the biologically active, cleaved form of this molecule, VEGF110. VEGF-A has been shown to cause neovascularization and leakage in models of ocular angiogenesis and vascular occlusion and is thought to contribute to pathophysiology of neovascular AMD, macular edema following RVO, and DME. The binding of ranibizumab to VEGF-A prevents the interaction of VEGF-A with its receptors (VEGFR1 and VEGFR2) on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation.
source - FDA Label (section 12.1)
Updated by MV
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Trial Design / Revenue (click to view full image)
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