FDA approves new Roche nAMD drug

Roche has announced significant updates regarding Susvimo, a therapeutic option for neovascular or 'wet' age-related macular degeneration (nAMD). This disease impacts approximately 20 million people globally and can lead to blindness if not treated. Susvimo offers an alternative to the conventional frequent eye injections that nAMD patients typically require. This drug leverages a refillable implant that continuously delivers medication into the eye. The implant is surgically placed in a one-time procedure and only needs to be refilled twice a year.

Initially approved by the FDA in 2021, Susvimo faced challenges and was voluntarily recalled by Roche's Genentech in the subsequent year due to performance issues. However, Roche has since made essential updates to both the implant and the refill needle to ensure they comply with the necessary standards.

Recently, Roche achieved another significant milestone in ophthalmology treatments. The FDA approved its bispecific antibody, Vabysmo, in a single-dose prefilled syringe (PFS). This new formulation is designed for the treatment of nAMD, diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). The single-dose PFS format aims to simplify the administration process for retina specialists, who previously had to prepare the treatment from vials.

These advancements mark important progress in the field of ophthalmology, offering improved treatment options and enhanced convenience for both patients and healthcare providers.