> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Outlook Therapeutics BLA for Wet AMD Therapy
- URL: https://www.fdaweb.com/outlook-therapeutics-bla-for-wet-amd-therapy/
- Published: 2022-03-31T12:00:00.000Z
- Updated: 2026-09-14T17:38:52.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5151501

Outlook Therapeutics has submitted a BLA for Lytenava (bevacizumab-vikg) for treating wet age-related macular degeneration (wet AMD). “If approved, Lytenava could replace the current practice of using unapproved repackaged IV \[intravenous\] bevacizumab sourced from compounding pharmacies for the treatment of wet AMD,” the company says.

The submission is based on data from the company’s NORSE ONE and TWO and Phase 3 pivotal trials. It also includes integrated safety data from the NORSE registration clinical program. “We observed a total of one ocular inflammation adverse event (iritis) reported from our three completed NORSE clinical studies,” the company says.

Bevacizumab is a recombinant humanized monoclonal antibody that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to certain receptors, according to the company. It was first approved in 2004 as Genentech’s Avastin as a first-line treatment for patients with metastatic colorectal cancer.

Outlook Therapeutics has entered into a partnership with FujiFilm Diosynth Biotechnologies for drug substance manufacturing, and with Aji Biopharma Services for finished drug product manufacturing.