FDA Label Expansions for Bispecifics in RVO-ME
Key Questions
What recent FDA label updates have been approved for Vabysmo and faricimab?
The FDA has approved label expansions for Vabysmo and faricimab to treat macular edema secondary to retinal vein occlusion (RVO) beyond 6 months. These updates are based on long-term data from the BALATON and COMINO studies. They strengthen bispecific options for retinal vascular disease management.
Which drugs now have extended labeling for RVO-associated macular edema?
Vabysmo and faricimab have received FDA label updates allowing treatment of macular edema due to RVO beyond 6 months. Vabysmo was previously approved for macular edema treatment, with this update extending its use. Faricimab's label now explicitly includes RVO beyond 6 months.
What data supported the FDA's label expansions for bispecifics in RVO?
The expansions are supported by long-term data from the BALATON and COMINO studies. These studies demonstrate the durability and efficacy of Vabysmo and faricimab in managing macular edema secondary to RVO. This bolsters their role in retinal vascular disease practice.
FDA approves Vabysmo and faricimab label updates for macular edema secondary to RVO beyond 6 months, based on BALATON/COMINO long-term data, bolstering durable bispecific options in retinal vascular disease practice.