Also known as: faricimab-svoa, Vabysmo
Vabysmo (faricimab-svoa) is an FDA-approved intravitreal biologic for neovascular age-related macular degeneration, diabetic macular edema, and macular edema following retinal vein occlusion. It is a bispecific antibody that targets both VEGF-A and Ang-2 pathways. Labeling reflects initial U.S. approval in 2022 with subsequent updates including RVO dosing changes in 2026.
Ocular Therapeutix stock surged 30% in premarket trading as the company prepared to release topline Phase 3 data for AXPAXLI in wet AMD. The SOL-1 trial results will be presented at the Macula Society meeting later in February. The company plans to file for FDA approval using one-year data if results are favorable.
4D Molecular Therapeutics said 4D-150 is in Phase 3 for wet AMD and nearing Phase 3 in diabetic macular edema. The company reported rapid enrollment, 18-month treatment burden reductions and favorable safety data.
The FDA approved updated labeling for Vabysmo to allow extended treatment of macular edema following retinal vein occlusion beyond six months. The label update removes the prior 6-month restriction and retains monthly 6 mg intravitreal dosing.
The FDA approved an updated Vabysmo label for macular edema following retinal vein occlusion beyond six months. The decision extends treatment based on data showing visual acuity gains and central subfield thickness reductions maintained through week 72.
Sanofi has submitted a revised acquisition bid for Ocular Therapeutix ahead of pivotal Phase 3 trial results for AXPAXLI, a sustained-release treatment for wet AMD. The deal could position Sanofi to re-enter the ophthalmology market it previously abandoned. The acquisition would give Sanofi access to innovative hydrogel delivery technology with potential applications beyond eye disease.
Ocular Therapeutix's Axpaxli outperformed low-dose Eylea in a Phase 3 trial for wet AMD, while Oculis Holding reported narrowed Q4 losses and expects Phase 3 trial readouts for OCS-01 in Q2 2026.
AAV-based gene therapy offers sustained intraocular delivery of anti-angiogenic agents with a single treatment for neovascular AMD, with leading clinical candidates including RGX-314, ADVM-022, 4D-150, and NG101.
