Search the database for deliberate release of GM medicinal products

Displaying 1 - 3 of 3

EU record number	Title	Company / Sponsor	Treated organism	Genetic modification
B/BE/25/BVW7	A Randomized, Controlled, Partially Masked, Phase 3b Study to Assess the Injection Burden, Efficacy, Safety, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec (ABBVRGX-314) in a Real-World Context in Subjects with Neovascular Age-Relate	AbbVie Deutschland GmbH & Co. KG	Humans	Non-replicating recombinant vector derived from adeno-associated virus AAV8 carrying the human anti-vascular endothelial growth factor (VEGF) antigen-binding fragment.
B/BE/25/BVW3	Phase 3, Open-label, Single-dose Study of CSL222 in Adolescent Male Subjects (≥ 12 to < 18 Years of Age) with Severe or Moderately Severe Hemophilia B	CSL Behring LLC	Humans	Recombinant adeno associated viral vector containing the codon-optimised human PADUA factor IX (FIX) gene
Only notified under the "contained use" procedure. Dossier submitted on 21/02/2018.	Efficacy and safety of bilateral intravitreal injection of GS010: a randomized, double-masked, placebo-controlled trial in subjects affected with G11778A ND4 leber hereditary optic neuropathy for up to one year.	GenSight Biologics	Humans	human wild-type MT-NDA (mitochondrial NADH Dehydrogenase 4)