Outlook Therapeutics Inc. (OTLK) announced that the U.S. FDA has granted its appeal following completion of the Formal Dispute Resolution process for ONS-5010/LYTENAVA (bevacizumab-vikg). Its investigational therapy for neovascular age-related macular degeneration (nAMD).
The company engaged in the FDR process after its recent Type A meeting with the Division of Ophthalmology and the Office of Specialty Medicine related to the December 30, 2025, Complete Response Letter (CRL) for the BLA of ONS-5010/LYTENAVA.
The FDA has now concluded that substantial evidence of effectiveness has been established based on the pivotal NORSE TWO trial, supported by confirmatory data from NORSE EIGHT and additional pharmacodynamic evidence. ONS-5010/LYTENAVA is an ophthalmic formulation of bevacizumab, designed specifically for retinal use. Unlike compounded bevacizumab currently used off-label, LYTENAVA is being developed to meet FDA standards for manufacturing, safety, and labelling, with the goal of providing a consistent, approved treatment option for patients with nAMD.
nAMD is a progressive eye disease caused by abnormal blood vessel growth under the retina, leading to rapid vision loss in older adults. Current therapies often require frequent injections, highlighting the need for more standardized and accessible treatment options.
Outlook plans to resubmit its Biologics License Application (BLA) in June 2026, with a Class 1 resubmission expected to carry a PDUFA decision within 60 days.CEO Bob Jahr said the decision "provides a clear path forward toward U.S. approval," adding that the company remains committed to delivering FDA-approved options for patients with nAMD.
If approved, ONS-5010/LYTENAVA would become the first FDA-approved ophthalmic formulation of bevacizumab, supported by an FDA-approved manufacturing and labelling standards.
OTLK has traded between $0.16 and $3.39 over the past year. The stock closed Friday's trading (May 22, 2026) at $0.30, down 6.94%. In pre-market trading Tuesday the stock is trading at $0.57, up 54.15%.
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