Genentech Shares One-Year Phase III Results for Vamikibart in Uveitic Macular Edema
Genentech reported one-year data from the Phase III MEERKAT and SANDCAT studies of vamikibart in uveitic macular edema. The treatment showed sustained vision improvements and reductions in macular thickness, with about two-thirds of eligible patients needing no retreatment after 16 weeks. The FDA has accepted Genentech's Biologics License Application, with a decision expected by July 2027.
Genentech, part of the Roche Group, reported 52-week results from the Phase III MEERKAT and SANDCAT trials at the AAO 2026 meeting in New Orleans. Vamikibart was compared with a sham procedure mimicking intravitreal injections in adults with uveitic macular edema, a leading cause of moderate to severe vision loss among uveitis patients.
Roughly two-thirds of eligible participants needed no further treatment after 16 weeks. The FDA accepted the Biologics License Application, with a decision anticipated by July 2027; submissions were also accepted in the EU, China and Japan. If cleared, it would be the first non-steroid targeted therapy for the condition.
Patients with uveitic macular edema, a sight-threatening inflammatory condition, could gain an alternative to long-term ocular steroids, which carry risks such as glaucoma and cataracts. A non-steroid targeted option may reduce reliance on off-label treatments. If approved, access and cost could shape how widely the therapy reaches patients, and the July 2027 decision timeline means any real-world benefit remains years away. Ophthalmology practices may need to adapt monitoring and retreatment protocols.