Outlook Therapeutics updates status of Lytenava (bevacizumabvikg) NORSE 1
Patient enrollment for NORSE 2 completed
Outlook Therapeutics remains on track to report topline results in August from NORSE 1, the company’s first registration clinical trial evaluating ONS-5010. Clinical experience and initial safety and efficacy data will be unveiled.
ONS-5010 is an investigational ophthalmic formulation of bevacizumab to treat wet age-related macular degeneration (AMD). If approved by the U.S. Food and Drug Administration (FDA), ONS-5010 will be the first FDA-approved ophthalmic formulation of bevacizumab for use in multiple retinal indications including wet AMD, diabetic macular edema (DME) and branch retinal vein occlusion (BRVO), according to the company.
ONS-5010 is a full-length, humanized anti-vascular endothelial growth factor (VEGF) recombinant monoclonal antibody (mAb) that works by blocking the growth of abnormal blood vessels secreted in the eyes of wet AMD patients. The drug is administered as an intravitreal injection, dosed monthly.
“The next key element in our streamlined regulatory pathway for ONS-5010 is our ongoing pivotal clinical trial, NORSE 2, which remains on track to complete enrollment within the next two months, with topline results expected in the third calendar quarter of 2021,” said Lawrence Kenyon, President of Outlook Therapeutics, in a statement.