FDA Approves Ophthalmic Bevacizumab for Wet AMD

The FDA approved bevacizumab-vikg (Lytenava, Outlook Therapeutics), an ophthalmic vascular endothelial growth factor (VEGF) inhibitor, for patients with neovascular age-related macular degeneration (nAMD), commonly known as wet AMD.he approval makes Lytenava the first and only FDA-approved ophthalmic formulation of bevacizumab for wet AMD in the US. The formulation was developed specifically for the eye and is administered by intravitreal injection. The manufacturer contrasted it with repackaged bevacizumab formulations originally intended for intravenous use, which have been used in retina care despite the previous absence of an FDA-approved ophthalmic formulation.

Bevacizumab is a recombinant humanized monoclonal antibody that binds VEGF-A and prevents its interaction with VEGF receptors. Inhibition of VEGF-A suppresses endothelial cell proliferation, neovascularization, and vascular permeability. Inhibition of such activity targets a pathophysiologic process that contributes to vision loss.

Lytenava is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to bevacizumab products or the formulation’s ingredients. Warnings and precautions address endophthalmitis and retinal detachment associated with intravitreal injections, postinjection increases in intraocular pressure, and the potential risk of arterial thromboembolic events. The most common adverse reactions reported in at least 1% of patients were conjunctival hemorrhage, eye pain, and vitreous floaters.

Outlook Therapeutics said it expects to make Lytenava available before the end of 2026.

Sources: Outlook Therapeutics. Outlook Therapeutics announces LYTENAVA FDA approval as the first and only FDA-approved ophthalmic bevacizumab for the treatment of wet AMD. News release. Outlook Therapeutics; July 24, 2026. Accessed July 27, 2026. 

US Food and Drug Administration. Novel drug approvals for 2026. Accessed July 27, 2026.