India, April 21 -- Outlook Therapeutics Inc. (OTLK), a clinical-stage biopharmaceutical company, announced on Tuesday the completion of a federal dispute resolution (FDR) meeting with the U.S. Food and Drug Administration (FDA) regarding the regulatory pathway for ONS-5010/ LYTENAVA, a treatment for age related macular degeneration.
LYTENAVA (bevacizumab-vika) is an investigational, humanized monoclonal antibody developed to bind with the human vascular endothelial growth factor (VEGF) to prevent endothelial cell proliferation in neovascular age-related macular degeneration. The company had previously received a complete response letter (CRL) from the FDA in December, 2025, regarding the biologics license application (BLA) for LYTENAVA. In...