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FDA approves Roche ’s Vabysmo, the first bispecific antibody for the eye, to treat two leading causes of vision loss
Vabysmo (faricimab-svoa) targetsand inhibitstwodiseasepathways that drive neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME)Vabysmo is the only injectable eye medicine approved simultaneously in the US for nAMD and DME, with flexible dosing regimens based on patient needBasel, 31  January 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved Vabysmo™ (faricimab-svoa) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME). Neovascular AMD and DM E...
Source: Roche Media News - January 31, 2022 Category: Pharmaceuticals Source Type: news

The Lancet publishes studies showing Roche ’s faricimab improved and maintained vision in two leading causes of vision loss, extending time between treatments up to four months
Two papers in The Lancet highlight one-year results from Roche ’s phase III trials evaluatingfaricimab inneovascular or “wet” age-related macular (nAMD) and diabetic macular edema (DME)Across four studies, about half of eligiblefaricimab patients were able to go four months between treatments, and approximately three-quarters could be treated every three months or longerReductions in central subfield thickness (CST) and resolution ofintraretinal fluid consistentlyfavouredfaricimab overaflibercept in DME, and meaningful and comparable CST reductions were seen innAMD in the first yearBasel, 24 January 2022 - Roche (SIX...
Source: Roche Media News - January 24, 2022 Category: Pharmaceuticals Source Type: news

FDA accepts application for Roche ’s faricimab for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME)
Basel, 29 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company ’s Biologics License Application (BLA), under Priority Review, for faricimab for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME). The FDA has also accepted the company’s submission for diabetic retinopathy.Faricimab will be the first and only bispecific antibody designed for the eye, if approved. It targets two distinct pathways – via angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) ...
Source: Roche Media News - July 29, 2021 Category: Pharmaceuticals Source Type: news