Outlook Therapeutics updates status of Lytenava (bevacizumabvikg) NORSE 1

July 24, 2020

Article

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.

Related: Study shows cryopreserved amniotic membranes improve SJS and TEN

“Additionally, we are preparing to initiate the NORSE 3 open-label study, which is meant to ensure enough patients have been exposed to ONS-5010 to meet the requirements for our planned BLA submission next year. We expect to commence NORSE 3 in the fourth calendar quarter of 2020.”

If approved, Outlook Therapeutics plans to commercialize ONS-5010 in the United States, Europe, Japan, and other markets. Additionally, the company expects to file ONS-5010 with the FDA as a new biologics license application (BLA) under the Public Health Service Act 351(a) regulatory pathway.

Patient enrollment for the NORSE 2 clinical trial for ONS-5010 has been completed.