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    1. Development
    2. Drug Approvals

    FDA OKs Roche vision loss drug in prefilled syringe

    July 5, 2024

    The U.S. FDA has approved Roche's bispecific antibody, Vabysmo, in a single-dose prefilled syringe (PFS) for the treatment of three leading causes of vision loss.
     
    Vabysmo PFS will become available to U.S. retina specialists in the coming months for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). 

    The treatment became the first FDA-approved bispecific antibody treatment for the eye when it won FDA approval in 2022 to treat AMD and DME.  Vabysmo was approved for a third indication — treatment of RVO — last October.

    The treatment was originally packaged in a vial and prepared by retina specialists for injection into the eye, with dosing every one to four months for wet AMD and DME and monthly for RVO. According to Roche, the newly approved PFS ready-to-use version will simplify administration. 

    AMD, DME and RVO affect the macula — the part of the eye that provides sharp vision — as damaged blood vessels leak fluid and blood and cause swelling. Vabysmo aims to prevent further destabilization of blood vessels in the eye, reducing inflammation and vessel leakage.