Outlook's path to FDA approval
March 2022 — Outlook submits first BLA to the FDA
May 2022 — FDA requests additional information to complete BLA / Outlook voluntarily withdraws BLA
August 2022 — Outlook resubmits first BLA to the FDA
October 2022 — FDA accepts first BLA from Outlook for LYTEVANA
August 2023 — FDA issues first CRL for LYTEVANA
September 2023 — Outlook requests Type A meeting with FDA
November 2023 — Outlook completes Type A meeting with FDA
December 2023 — Outlook submits Special Protocol Assessment (SPA) for “required additional adequate and well-controlled study of LYTEVANA
January 2024 — Outlook receives agreement from FDA to start NORSE EIGHT under SPA and doses first patient
March 2024 — Outlook receives European Union Positive CHMP Opinion for LYTEVANA
May 2024 — Outlook submits UK Marketing Authorization Application (MAA) / receives European Commission Marketing Authorization for LYTENAVA
July 2024 — Outlook receives UK MHRA marketing authorization for LYTEVANA
September 2024 — Outlook completes enrollment in NORSE EIGHT
January 2025 — Outlook releases 12-week efficacy and safety results from NORSE EIGHT
February 2025 — Outlook submits second BLA to FDA
April 2025 — FDA accepts second BLA
August 2025 — FDA issues second CRL to Outlook
September 2025 — Outlook requests second Type A meeting / provides update
November 2025 — Outlook submits third BLA to FDA
December 2025 — FDA issues third CRL to Outlook
February 2026 — Outlook requests third Type A meeting with FDA
March 2026 — Outlook provides update from Type A meeting
April 2026 — FDR request accepted by FDA
May 2026 — Outlook wins appeal following FDR
June 2026 — Outlook submits fourth BLA
The US Food and Drug Administration has approved bevacizumab-vikg (ONS-5010/LYTENAVA) from Outlook Therapeutics for the treatment of wet age-related macular degeneration. According to the company, this approval marks LYTENAVA as the first and only FDA-approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the United States.1
Bob Jahr, CEO of Outlook Therapeutics, commented on the approval in a press release from the company, saying, "Today's approval represents a defining moment for Outlook Therapeutics and, more importantly, for the physicians and patients we have been working to serve. With the approval of LYTENAVA, physicians now have access to the first FDA-approved ophthalmic bevacizumab developed specifically for the eye. We believe this approval has the potential to meaningfully advance patient care and establish LYTENAVA as an important new treatment option for retina specialists and wet AMD patients across the United States."
The approval ends a long journey seeking approval set out by Outlook Therapeutics in March 2022 with its first BLA submission to the FDA. Previously, the company had received 3 CRLs from the FDA2:
- First CRL: Issued in August 2023. This was due to Chemistry, Manufacturing, and Controls (CMC) issues, open observations from manufacturing inspections, and a lack of substantial evidence, according to the company.
- Second CRL: Issued in August 2025. This letter cited a lack of substantial evidence of effectiveness and recommended more confirmatory efficacy data, according to the company.
- Third CRL: Issued on December 31, 2025, for the subsequent Biologics License Application (BLA) resubmission. The FDA stated that the additional data provided did not alter its previous conclusion that confirmatory evidence of efficacy is needed.
Prior to approval, the FDA granted Outlook Therapeutics' appeal following completion of the Formal Dispute Resolution (FDR) process with the Office of New Drugs (OND), concluding substantial evidence of effectiveness was established for bevacizumab-vikg for the treatment of nAMD.3
The company noted that it is now initiating the commercial launch of LYTENAVA, including “expanding reimbursement and patient support access, building an industry-leading, specialized retina commercial organization, and supporting physicians nationwide.” The company expects to make LYTENAVA available to eligible patients in the US before year-end.
LYTENAVA already holds marketing authorization from the European Commission and the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) for wet AMD, with commercial launches underway in Germany, Austria, and the United Kingdom.
Bevacizumab-vikg is a recombinant humanized monoclonal antibody binding to all isoforms of human vascular endothelial growth factor (VEGF), neutralizing VEGF's biologic activity through steric blockade of VEGF binding to its receptors VEGFR-1 (Flt-1) and VEGFR-2 (KDR) on endothelial cell surfaces. Following intravitreal injection, blockade of VEGF-receptor interaction reduces endothelial cell proliferation, vascular leakage, and neovascularization in the retina. The agent is produced in the United States and, if approved, would carry FDA-approved labeling and pharmacovigilance infrastructure, differentiating it from compounded bevacizumab preparations currently used off-label in retinal practice.3
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