The FDA has officially acknowledged receipt of Outlook Therapeutics, Inc’s recently resubmitted Biologics License Application (BLA) for ONS-5010 (LYTENAVA; bevacizumab-vikg) to treat wet age-related macular degeneration (AMD).
That was fast … didn’t the company just resubmit this package?
Practically. In fact, our coverage on the resubmission was published at the start of the month.
And for some background on the events leading up to its resubmission (including the need for one in the first place)—see here.
Can we get a refresh on the candidate in question?
ONS-5010—branded as LYTENAVA in the European Union and United Kingdom—is an intravitreal (IVT) injection administered on a monthly basis.
About its active ingredient: Bevacizumab is a recombinant humanized monoclonal antibody (mAb) that selectively binds, with high affinity, to all isoforms (structurally similar proteins encoded by different genes) of human vascular endothelial growth factor (VEGF).
And how does its mechanism of action work?
In two stages:
- At the time of injection, the mAb neutralizes VEGF's biologic activity by blocking it from binding to receptors on the surface of endothelial cells.
- After injection, this blockade leads to a reduction in endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.
Can I get a look at its supporting clinical data?
So about this BLA resubmission …
Categorized as a Class 1 resubmission, this marks the fourth package Outlook has had the FDA review.
It also follows the company’s pursuit (and completion) of a Federal Dispute Resolution (FDR) process.
And has the FDA assigned a PDUFA date yet?
Indeed. The agency has set a Prescription Drug User Fee Act (PDUFA) target action date of July 29, 2026.
And keep in mind: If approved, ONS-5010/LYTENAVA will become the first on-label bevacizumab product specifically formulated for IVT retinal use in the United States.
Also: The company has reportedly already initiated pre-launch activities in anticipation.