Outlook Therapeutics

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Outlook Therapeutics is a biopharmaceutical company focused on developing and commercializing ONS-5010/LYTENAVA (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of retinal diseases, including wet age-related macular degeneration (AMD). The company's lead product candidate, ONS-5010, is designed to be the first FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal diseases. ONS-5010 is a recombinant humanized monoclonal antibody that selectively binds to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF's biologic activity through steric blocking.


Outlook Therapeutics has completed three clinical trials for ONS-5010 - NORSE ONE, NORSE TWO, and NORSE THREE. The pivotal NORSE TWO trial met its primary and secondary endpoints with high statistical significance and clinical relevance. In March 2024, Outlook Therapeutics received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for ONS-5010/LYTENAVA (bevacizumab gamma) to treat wet AMD in the European Union. The company is also conducting the NORSE EIGHT trial, a 90-day non-inferiority study comparing ONS-5010 to ranibizumab, with top line data expected in the fourth quarter of 2024.

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HQ location:
485 Route 1 South Building F, Suite 320 Iselin NJ USA
Founded year:
2011
Employees:
11-50
IPO status:
Public
Total funding:
USD 340.3 mn
Last Funding:
USD 5.0 mn (Post IPO Equity; Apr 2024)
Last valuation:
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