On July 24, 2026 local time, Outlook Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Lytenava (bevacizumab-vikg) for marketing. Lytenava (bevacizumab-vikg) is a recombinant humanized IgG1 monoclonal antibody that specifically targets human vascular endothelial growth factor (VEGF). This approval makes it the first FDA-approved ophthalmic bevacizumab formulation for wet AMD in the United States.
Indication
The U.S. Food and Drug Administration (FDA) approved Lytenava (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (nAMD), commonly known as "wet AMD."
Mechanism of Action
Lytenava (bevacizumab-vikg) is a recombinant humanized IgG1 monoclonal antibody that specifically targets human vascular endothelial growth factor (VEGF). Bevacizumab binds to VEGF and prevents it from binding to the receptors (Flt-1 and KDR) on the surface of endothelial cells. Lytenava (bevacizumab-vikg) binds to all VEGF-A isoforms, thereby blocking interactions with VEGFR-1 and VEGFR-2 receptors. By inhibiting VEGF-A, Lytenava (bevacizumab-vikg) inhibits endothelial cell proliferation, neovascularization, and vascular permeability. Inhibition of these activities addresses the pathophysiological processes leading to vision loss.
Contraindications
1. Ocular or periocular infection.
2. Active intraocular inflammation.
3. Hypersensitivity to bevacizumab products or to any ingredient in Lytenava (bevacizumab-vikg) (hypersensitivity reactions may manifest as severe intraocular inflammation).
Warnings and Precautions
1. Intravitreal injections may be associated with endophthalmitis and retinal detachment. Aseptic injection technique must always be used during administration. Patients should be monitored after injection to enable early treatment in case of infection.
2. Elevated intraocular pressure may occur after injection (up to 60 minutes). Intraocular pressure should be monitored before and after injection and managed appropriately.
3. Although the incidence of arterial thromboembolic events (ATE) was low in Lytenava clinical trials, there is a potential risk of ATE (defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death, including death of unknown cause) with intravitreal use of VEGF inhibitors.
Adverse Reactions
The most common adverse reactions (≥1%) in patients treated with Lytenava were conjunctival hemorrhage (4%), eye pain (2%), and vitreous floaters (2%). These are not all the possible side effects of Lytenava.
Lytenava (bevacizumab-gamma) has also received a centralized marketing authorization from the European Commission in the European Union and marketing authorization from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom for the treatment of wet AMD.
