Outlook Therapeutics Stock Sinks After FDA Rejects Eye Drug Again
Outlook Therapeutics, Inc. (NASDAQ:OTLK) stock sank to a new 52-week low on Friday after the U.S. Food and Drug Administration (FDA) again rejected its Lytenava filing for wet AMD, citing insufficient evidence of effectiveness.
On Wednesday, the FDA issued a complete response letter (CRL) to Outlook Therapeutics’ resubmission of the biologics license application (BLA) for ONS-5010/Lytenava (bevacizumab-vikg).
The letter indicates that the FDA cannot approve the application in its present form for wet age-related macular degeneration (wet AMD).
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Regulatory History And Prior CRLs
Wet AMD is a severe form of AMD where abnormal blood vessels grow under the retina, leaking blood and fluid, causing rapid central vision loss, characterized by wavy lines, dark spots, or blurred vision.
In August 2025, the FDA issued a CRL to ONS-5010 resubmission. The CRL included only one deficiency for a lack of substantial evidence of effectiveness.
In August 2023, Outlook Therapeutics received a complete response letter from the FDA regarding ONS-5010.
The FDA noted that the additional mechanistic and natural history data provided in the BLA resubmission do not alter the previous review conclusion.
Efficacy Evidence Remains Key Issue
While the one adequate and well-controlled study demonstrated efficacy, the FDA has again recommended that confirmatory evidence of efficacy be submitted to support the application; however, the FDA has not indicated what type of confirmatory evidence would be acceptable.
The ONS-5010 BLA resubmission was based on the complete data set from the NORSE clinical trial program.
Outlook Therapeutics is currently exploring all available pathways for potential approval in the U.S. and intends to continue its efforts to expand into additional markets in Europe and other regions.
Industry Context And Peer Setback
In March 2025, Opthea Limited (NASDAQ:OPT) global Phase 3 COAST trial for wet AMD did not meet its primary endpoint of mean change in best corrected visual acuity (BCVA) from baseline to week 52.
The trial evaluated the efficacy and safety of intravitreally administered 2 mg sozinibercept every four or eight weeks in combination with 2 mg Regeneron Pharmaceuticals Inc.’s (NASDAQ:REGN) Eylea (aflibercept), as per label, every eight weeks after a loading phase for wet AMD.
OTLK Price Action: Outlook Therapeutics shares were down 60.82% at $0.61 during premarket trading on Friday. The stock is trading at a new 52-week low, according to Benzinga Pro data.
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