Outlook Therapeutics doses first subject in NORSE EIGHT trial

Outlook Therapeutics announced that the first subject has been dosed in the NORSE EIGHT clinical trial evaluating ONS-5010 in neovascular age-related macular degeneration patients. The NORSE EIGHT study is a randomized, controlled, parallel-group, masked, non-inferiority study of approximately 400 treatment naive, wet AMD subjects randomized in a 1:1 ratio to receive 1.25 mg ONS-5010 or 0.5 mg ranibizumab intravitreal injections. Subjects will receive injections at Day 0, Week 4, and Week 8 visits. The primary endpoint will be mean change in Best Corrected Visual Acuity from baseline to Week 8. Outlook Therapeutics expects NORSE EIGHT topline results and resubmission of the ONS-5010 BLA by the end of calendar year 2024. Earlier this month, Outlook Therapeutics announced that it received written agreement from the FDA under an SPA for NORSE EIGHT. The FDA has reviewed and agreed upon the NORSE EIGHT trial protocol pursuant to the SPA. If the NORSE EIGHT trial is successful, it would satisfy the FDA’s requirement for a second adequate and well-controlled clinical trial to address fully the clinical deficiency identified in the Complete Response Letter. In addition, through a Type A meeting and additional interactions, Outlook Therapeutics has identified the approaches needed to resolve the Chemistry, Manufacturing and Controls comments in the CRL. Outlook Therapeutics is working to address the open CMC items in the CRL and expects to resolve these comments prior to the expected completion of NORSE EIGHT.