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Outlook Therapeutics Announces LYTENAVA™ (bevacizumab-vikg), Anticipated Brand Name for ONS-5010, If Approved
Outlook Therapeutics intends to market ONS-5010 as LYTENAVA™ (bevacizumab-vikg), if approved.LYTENAVA™ (bevacizumab-vikg), an investigational ophthalmic
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"Outlook Therapeutics intends to market ONS-5010 as LYTENAVA™ (bevacizumab-vikg), if approved.LYTENAVA™ (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for retinal indications, is currently in two registration clinical trials (NORSE 1 and NORSE 2) to treat wet age-related macular degeneration (wet AMD). CRANBURY, N.J., March 05, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ: OTLK) (the “Company”), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that it has received U.S. Food and Drug Administration (FDA) tentative approval of the Tradename for ONS-5010 as LYTENAVA™ (bevacizumab-vikg). The Tradename is conditionally approved by FDA and will be subject to further review at the time of the Company’s planned filing of a new biologics license application (BLA) with the FDA for LYTENAVA™ (bevacizumab-vikg) in 2021. \n About LYTENAVA™ (bevacizumab-vikg) LYTENAVA™ (bevacizumab-vikg) is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet AMD and other retinal diseases. LYTENAVA™ (bevacizumab-vikg) is currently being evaluated in two adequate and well-controlled registration clinical trials for wet AMD (NORSE 1 and NORSE 2) and, if successful, is expected to be submitted to the FDA as a new BLA for this ophthalmic indication. If approved, LYTENAVA™ (bevacizumab-vikg) would be the first and only FDA-approved ophthalmic formulation of bevacizumab to treat retinal diseases. The Company currently intends to commercialize LYTENAVA™ (bevacizumab-vikg) in both vials and single-use pre-filled syringes. LYTENAVA™ (bevacizumab-vikg) is a full-length, humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody (or mAb) that inhibits VEGF and associated angiogenic activity. With wet AMD, abnormally high levels of VEGF are secreted in the eye. VEGF is a protein that promotes the growth of new abnormal blood vessels. Anti-VEGF injection therapy blocks this growth. Since the advent of anti-VEGF therapy, it has become the standard of care treatment option within the retina community globally. About Outlook Therapeutics, Inc. Outlook Therapeutics is a late clinical-...