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Profile
From SEC filingsCompany description
We are a biopharmaceutical company that has developed ONS-5010/LYTENAVA™ as the first ophthalmic formulation of bevacizumab approved by the European Commission in the European Union, or EU, and the Medicines and Healthcare products Regulatory Agency, or MHRA, in the United Kingdom, or UK, for use in adults for the treatment of wet age-related macular degeneration, or wet AMD. In June 2025, we launched directly into the initial markets of Germany and the UK. Additionally, our Biologics License Application, or BLA, is currently under review at the U.S. Food and Drug Administration, or FDA, for the use of ONS-5010/LYTENAVA as a treatment for wet AMD in the United States. If approved by the FDA., our goal is to also launch directly in the United States as the first and only approved ophthalmic bevacizumab for the treatment of wet AMD. In addition to Europe and the United States., we may seek approval to launch ONS-5010/LYTENAVA the product in other markets. ONS-5010/LYTENAVA is manufactured in the United States. Bevacizumab is a full-length, humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody, or mAb, that inhibits VEGF and associated angiogenic activity. Prior to the approval of ONS-5010/LYTENAVA in the EU and UK, bevacizumab had only been approved for use in the treatment of various forms of cancer and had not been optimized for use in the treatment of retina diseases.
Read the full filing description · filed 19 Dec 2025
At a glance
- Sector
- Healthcare
- Industry
- Biological Products, (No Diagnostic Substances)
- CEO
- Robert C. Jahr
Source: SEC filings. Information and analytics, not investment advice.