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Country
US
Industry
Health Care
Market Cap
Small Cap
Num. Employees
17
IPO Date
Jun 13, 2016
Country
US
Industry
Health Care
Outlook Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which engages in the development of ONS-5010/LYTENAVA. The company is headquartered in Iselin, New Jersey and currently employs 17 full-time employees. The company went IPO on 2016-06-13. The firm focuses on developing and commercializing ONS-5010 (LYTENAVA (bevacizumab-vikg)), an ophthalmic formulation of bevacizumab for use in retinal indications. The firm's product candidate, ONS-5010, which is developed to be administered as an intravitreal injection for the treatment of wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and branch retinal vein occlusion (BRVO). Bevacizumab is a full-length, humanized anti- Vascular Endothelial Growth Factor (VEGF) recombinant monoclonal antibody (mAb), that inhibits VEGF and associated angiogenic activity. VEGF is a protein that promotes the growth of new abnormal blood vessels. Its biologics license application (BLA) for ONS-5010 in wet AMD involved three clinical trials, which include NORSE ONE, NORSE TWO and NORSE THREE. The firm sells ONS-5010 in the United States, United Kingdom, Europe, Japan and other markets.
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The firm says ONS-5010 did not surpass the 95% threshold for the primary endpoint in NORSE EIGHT despite the difference between ONS-5010 and ranibizumab falling within the pre-specified noninferiority margin at eight weeks.
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