Author(s): Martin David Harp
Key Takeaways
- FDA review proceeds under a Class 1 resubmission with a July 29, 2026 PDUFA date after three CRLs since the initial 2022 submission.
- OND’s FDR concluded NORSE TWO efficacy plus NORSE EIGHT confirmatory, mechanistic, and pharmacodynamic evidence collectively meet “substantial evidence” for nAMD.
- Bevacizumab-vikg is a recombinant humanized anti-VEGF mAb blocking VEGF binding to VEGFR-1 (Flt-1) and VEGFR-2 (KDR) on endothelial cells.
- NORSE TWO (n=228) was a superiority design versus ranibizumab per label, meeting primary/secondary endpoints with high statistical significance and clinical relevance.
- Across early NORSE registration studies, ocular inflammation was rare, and the most common ≥5% adverse reaction was injection-associated conjunctival hemorrhage.
The US Food and Drug Administration has accepted for review the Biologics License Application (BLA) for ONS-5010 (LYTENAVA) for the treatment of neovascular age-related macular degeneration (nAMD) from Outlook Therapeutics.1
The resubmission is considered a Class 1 submission and has a current PDUFA target action date of July 29, 2026.
The company had submitted the BLA to the FDA at the beginning of June 2026, following a CRL the company had received in December 2025. The journey to FDA approval has been an arduous one for the company, starting in 2022 with the first BLA submission to the FDA. Since then, the company has received 3 CRLs from the organization—with many back-and-forth meetings to determine the path forward.
An appeal was cast by Outlook on the December 2025 CRL,2,3 which was approved by the Office of New Drugs (OND) in a Formal Dispute Resolution (FDR). In the FDR, the OND determined that the results of the NORSE TWO trial (NCT03834753), together with confirmatory evidence from NORSE EIGHT natural history data, and mechanistic and pharmacodynamic data, collectively establish substantial evidence of effectiveness for bevacizumab-vikg in nAMD.
Read more: https://shorturl.at/xyKYb
Source: Ophthalmology Times