
FDA approves Vabysmo to treat vision-threatening retinal conditions
pharmafile | January 31, 2022 | News story | Sales and Marketing |
The FDA has approved vabysmo (faricimab-svoa) for the treatment of neovascular or “wet” age-related macular degeneration and diabetic macular edema. Neovascular AMD and DME are two leading causes of vision loss worldwide.
Vabysmo is the first and only FDA-approved injectable eye medicine for nAMD and DME, which improves and maintains vision with treatments from one to four months apart in the first year following four initial monthly doses.
The approval is based on positive results across four Phase III studies in wet AMD and DME. The studies consistently demonstrated that patients treated with Vabysmo, administered at intervals of up to four months, achieved non-inferior vision gains versus aflibercept, given every two months in the first. Vabysmo was generally well tolerated in all four studies, with a favourable benefit-risk profile.
The treatment will be available in the US in the coming weeks, according to Roche. The EMA is also currently evaluating the Vabysmo Marketing Authorisation Application for wet AMD and DME.
“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 III investigator. “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.”
Lina Adams






