Outlook Therapeutics, Inc. (OTLK) announced that the U.S. FDA has accepted its resubmitted BLA for ONS-5010/LYTENAVA as a proposed treatment for neovascular age-related macular degeneration, also known as wet AMD. The agency has classified the filing as a Class 1 review and assigned a PDUFA target action date of July 29, 2026.
Wet AMD is a progressive retinal disease that leads to vision loss due to abnormal blood vessel growth and fluid leakage in the retina. Current treatment often requires frequent intravitreal injections, and many patients rely on off-label formulations of bevacizumab that lack FDA-approved ophthalmic labelling.
About ONS-5010/LYTENAVA
ONS-5010/LYTENAVA is an ophthalmic formulation of bevacizumab developed specifically for retinal use and manufactured in the U.S. In the European Union and United Kingdom, the therapy—marketed as bevacizumab gamma— already holds centralized Marketing Authorization for the treatment of wet AMD.
In the U.S., ONS-5010 remains investigational, and if approved, would become the first FDA-approved ophthalmic formulation of bevacizumab, supported by standardized manufacturing, FDA-approved labeling, and formal pharmacovigilance systems.
Company Statement
"We are very pleased that the FDA has accepted our resubmitted BLA to review the labelling as part of the final step toward potential approval," said Bob Jahr, Chief Executive Officer of Outlook Therapeutics. He added that the acceptance represents an important milestone for the company, its partners, and the retina community, and noted ongoing collaboration with the FDA during the review period.
Outlook Therapeutics has already initiated pre-launch activities in anticipation of a potential approval later this year.
Mechanism of Action
Bevacizumab-vikg is a recombinant humanized monoclonal antibody that binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF), blocking its interaction with VEGFR-1 and VEGFR-2 on endothelial cells.
By inhibiting VEGF signalling, the therapy aims to reduce abnormal blood vessel growth, vascular leakage, retinal swelling—key drivers of wet AMD progression.
OTLK has traded between $0.16 and $3.39 over the past year. The stock closed Monday's trading at $1.16, down 4.92%. In pre-market trading the stock is at $1.20, up 3.45%.
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