Outlook Therapeutics, Inc. (NASDAQ:OTLK) shares are trading higher Tuesday after the company announced that the U.S. Food and Drug Administration granted its appeal following the Formal Dispute Resolution process for ONS-5010 or LYTENAVA (bevacizumab-vikg).
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FDA Grants Appeal For LYTENAVA
Outlook said the FDA concluded that substantial evidence of effectiveness has been established for LYTENAVA for the treatment of neovascular age-related macular degeneration.
The company said it now expects to resubmit the Biologics License Application for ONS-5010 or LYTENAVA in June 2026.
Outlook initiated the Formal Dispute Resolution process following a Type A meeting with the FDA's Division of Ophthalmology and Office of Specialty Medicine related to the Complete Response Letter issued on Dec. 30.
According to the company, the FDA determined that the results of the NORSE TWO trial, along with confirmatory evidence including NORSE EIGHT, natural history data and mechanistic and pharmacodynamic data, establish substantial evidence of effectiveness for the treatment.
The FDA also directed the Division of Ophthalmology and Office of Specialty Medicine to work with Outlook on final labeling discussions.
The company said the resubmission is expected to be classified as a Class 1 resubmission, with a PDUFA date and FDA decision anticipated within 60 days of the agency receiving the filing.
"We appreciate the opportunity to engage with the FDA through the FDR process," said CEO Bob Jahr. "The Agency’s action on our appeal provides a clear path forward toward U.S. approval."
Jahr added that the company remains focused on bringing additional FDA-approved treatment options to patients with neovascular age-related macular degeneration.
If approved, Outlook said ONS-5010 or LYTENAVA would become the first FDA-approved ophthalmic formulation of bevacizumab supported by an FDA-approved manufacturing process, labeling and pharmacovigilance.
Outlook Shares Advance
OTLK Price Action: At the time of publication, Outlook shares are trading 45.85% higher at 45 cents, according to data from Benzinga Pro.
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