At-a-Glance
- Outlook Therapeutics announced an update following a Type A meeting with the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for ONS-5010/LYTENAVA™ (bevacizumab-vikg).
- The FDA indicated that additional confirmatory evidence of effectiveness is required before the therapy can progress toward approval.
- The investigational therapy targets wet age-related macular degeneration (wet AMD), a major cause of vision loss.
- LYTENAVA™ already has Marketing Authorization in the European Union and the United Kingdom for the treatment of wet AMD.
Written By: Karthikteja Macharla, PharmD
Reviewed By: Pharmacally Editorial Team
Outlook Therapeutics has provided an update on its regulatory discussions with the U.S. Food and Drug Administration following a Type A meeting held to address the agency’s December 30, 2025 Complete Response Letter (CRL) for the Biologics License Application (BLA) of ONS-5010/LYTENAVA™ (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD).
The meeting focused on clarifying the FDA’s concerns regarding substantial evidence of effectiveness and identifying possible regulatory pathways toward approval. According to the company, discussions centered on the type of confirmatory evidence required to support the application.
“Our goal is to reach alignment on the confirmatory evidence supporting our application and to identify the most efficient pathway toward potential approval,” said Bob Jahr, Chief Executive Officer of Outlook Therapeutics, noting that the company will continue engaging with the FDA to clarify expectations and evaluate regulatory options to advance the program.
The BLA is supported by data from the NORSE TWO Phase 3 randomized, double-masked, active-controlled trial, which met its primary and key secondary endpoints and demonstrated statistically significant improvements in visual acuity. Additional supportive evidence from NORSE EIGHT and other submitted data provided functional and pharmacodynamic confirmation consistent with the drug’s anti-VEGF mechanism. The program has also demonstrated a favourable safety profile, with no safety concerns identified by the FDA.
ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab designed specifically for intravitreal use and manufactured entirely in the United States through a fully domestic supply chain. If approved, it could become the first FDA-approved ophthalmic formulation of bevacizumab, offering standardized manufacturing, regulated labeling, and formal pharmacovigilance oversight.
Outside the United States, LYTENAVA™ (bevacizumab gamma) has already received centralized marketing authorization in the European Union and approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of wet AMD. Commercial launch in certain EU countries remains subject to national pricing and reimbursement decisions.
Bevacizumab-vikg is a recombinant humanized monoclonal antibody that binds with high affinity to vascular endothelial growth factor (VEGF), blocking its interaction with VEGF receptors on endothelial cells. Following intravitreal injection, this inhibition reduces abnormal blood vessel formation, vascular leakage, and retinal damage associated with wet AMD.
Outlook Therapeutics stated it will continue discussions with the FDA as it seeks regulatory clarity and evaluates the next steps toward potential U.S. approval of LYTENAVA.
Reference
Outlook Therapeutics Provides Update Following Type A Meeting with FDA Regarding ONS-5010/LYTENAVA™ (bevacizumab-vikg), 05 March 2026, Outlook Therapeutics Provides Update Following Type A Meeting with FDA Regarding ONS-5010/LYTENAVA™ (bevacizumab-vikg) – Outlook Therapeutics, Inc.
FDA Issues Third CRL for Outlook Therapeutics’ ONS-5010/LYTENAVA in Wet AMD – What It Means, 01 January 2026, https://pharmacally.com/fda-issues-third-crl-for-outlook-therapeutics-ons-5010-lytenava-in-wet-amd-what-it-means/
Outlook Therapeutics Seeks FDA Type A Meeting Following CRL for LYTENAVA™ in Wet AMD, 12 February 2026, https://pharmacally.com/outlook-therapeutics-seeks-fda-type-a-meeting-following-crl-for-lytenava-in-wet-amd/
About Writer
Karthik Teja, Pharm.D.
He is a Pharm.D. graduate with a strong interest in clinical research, pharmacovigilance, and medical writing. In his words, he is passionate about converting complex medical information into clear, evidence-based scientific communication, committed to contributing to patient safety and advancing healthcare through accurate and impactful medical content.