FDA approves Lytenava for wet AMD

The FDA approved Lytenava for the treatment of neovascular age-related macular degeneration, according to a press release from Outlook Therapeutics.

The approval of Lytenava is marks the first and only FDA-approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the United States.

Bevacizumab-vikg, a recombinant humanized IgG1 monoclonal antibody specific for human VEGF, binds VEGF and inhibits interactions of VEGF with Flt-1 and KDR receptors on the surface of endothelial cells. The approved formulation of bevacizumab binds to VEGF-A and prevents interaction with VEGFR-1

Lytenava is now the first and only FDA-approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the United States.

The approved formulation of bevacizumab binds to VEGF-A and prevents interaction with VEGFR-1 and VEGFR-2, suppressing the proliferation of endothelial cells, neovascularization and vascular permeability, which can lead to vision loss, according to press release.

“For the retina community, this approval represents an important new chapter,” Bob Jahr, CEO of Outlook Therapeutics, told Healio. “Physicians now have access to the first and only FDA-approved ophthalmic formulation of bevacizumab developed specifically for intravitreal administration and supported by rigorous clinical evidence, validated manufacturing, approved labeling for wet AMD, comprehensive quality systems and ongoing FDA oversight. We know retina specialists have been waiting a long time for this option, and we are focused on making Lytenava available before year-end while providing the reimbursement and patient support resources needed to help physicians integrate it into routine clinical practice for patients with wet AMD.”

Under the Biologics Price Competition and Innovation Act, the formulation is expected to have 12 years of reference product exclusivity.