Genentech Reports the US FDA Acceptance of sBLA for Vabysmo to Treat Retinal Vein Occlusion
Shots:
- The US FDA has accepted the sBLA for Vabysmo to treat macular edema. The sBLA was based on the P-III studies (BALATON) & (COMINO) evaluating Vabysmo (6.0mg, up to q16w) vs aflibercept (2.0mg) in 553 patients with branch retinal vein occlusion & 729 patients with central retinal or hemiretinal vein occlusion
- Both studies met their 1EPs & showed non-inferior visual acuity gains over aflibercept with early & sustained vision improvement, and vision gains in both trials were +16.9 vs +17.5 letters & 16.9 vs +17.3 letters @24wks.
- The 2EPs showed a rapid & robust drying of retinal fluid, reductions in CST were comparable across treatment arms. In both studies, 34% vs 21% & 44% vs 30% had an absence of macular leakage
Ref: Businesswire | Image: Genentech
Related News:- Genentech Reports P-III (BALATON) and (COMINO) Study Results of Vabysmo (faricimab-svoa) for Retinal Vein Occlusion
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