FDA approves Vabysmo for nAMD, DME
The U.S. Food and Drug Administration approved Vabysmo (faricimab-svoa; Roche) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME), according to a company press release.
Approval is based on results from four phase 3 studies that demonstrated non-inferior vision gains in patients treated with Vabysmo given at intervals of up to 4 months compared to patients treated with aflibercept given every 2 months in the first year.
Vabysmo was generally well tolerated in the studies, with conjunctival hemorrhage the most common adverse reaction.
“Vabysmo represents an important step forward for ophthalmology. It is the first bispecific antibody approved for the eye and a major advance in treating retinal conditions such as neovascular AMD and diabetic macular edema,” said Charles Wykoff, MD, PhD, Director of Research at Retina Consultants of Texas in Houston and a Vabysmo phase 3 investigator in a statement. “With Vabysmo, we now have the opportunity to offer patients a medicine that could improve their vision, potentially lowering treatment burden with fewer injections over time.”
Read the full press release here.