FDA approves Vabysmo for treatment of wet AMD, DME
Click Here to Manage Email Alerts
The FDA has approved Vabysmo for the treatment of wet age-related macular degeneration and diabetic macular edema, according to a press release from Genentech.
Vabysmo (faricimab-svoa) is an injectable eye medicine that works by targeting and inhibiting Ang-2 and VEGF-A pathways.
“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 wet AMD and diabetic macular edema,” Charles C. Wykoff, MD, PhD, director of research at Retina Consultants of Texas in Houston and a Vabysmo phase 3 investigator, said in the release. “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.”
The approval is based on positive results from four phase 3 studies investigating the therapy’s efficacy and safety in patients with wet AMD and DME. In the first year, patients treated with Vabysmo at intervals spanning up to 4 months experienced noninferior vision gains compared with patients treated every 2 months with aflibercept.
Genentech is administering long-term extension studies in patients with wet AMD and DME and is conducting two phase 3 trials investigating the safety and efficacy of Vabysmo in patients with macular edema following retinal vein occlusion.
Vabysmo will be available in the U.S. in the coming weeks, according to the release. In addition, the European Medicines Agency is evaluating a marketing authorization application for Vabysmo for wet AMD and DME.
Read more about
Click Here to Manage Email Alerts