FDA approves updated Roche nAMD drug

Roche announced that the FDA has approved updates to Susvimo, a treatment for neovascular or 'wet' age-related macular degeneration (nAMD).

Susvimo offers an alternative to the regular eye injections currently needed for nAMD, which affects 20 million people globally and can lead to blindness if untreated. The drug delivers medication continuously through a refillable implant — surgically inserted into the eye during a one-time procedure — requiring only two refills a year. 

Initially approved by the FDA in 2021, Susvimo was voluntarily recalled by Roche's Genentech the following year due to performance issues. The company has since updated the implant and refill needle, ensuring they meet the necessary standards.

A few weeks ago, Roche marked another milestone in its ophthalmology treatments when the FDA approved its bispecific antibody, Vabysmo, in a single-dose prefilled syringe (PFS) for treating nAMD, diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). This new format will simplify administration for retina specialists, who previously prepared the treatment from vials.