Outlook Therapeutics to Resubmit BLA for ONS-5010 Despite Missing Primary Endpoint in NORSE EIGHT Trial

Resubmission Plans:
Outlook Therapeutics plans to resubmit its Biologics License Application (BLA) for ONS-5010 in the first quarter of 2025, following the receipt of full month 3 efficacy and safety results from the NORSE EIGHT trial, which are expected in January 2025234.

NORSE EIGHT Trial Results:
The NORSE EIGHT trial did not meet its primary endpoint of non-inferiority compared to ranibizumab at week 8, but preliminary data showed an improvement in vision and a favorable safety profile for ONS-5010234.

European Approval:
ONS-5010, branded as Lytenava, has received European Commission and MHRA Marketing Authorization for the treatment of wet AMD, with plans for commercial launch in the UK and Germany in the first half of 202524.

Clinical Program:
The BLA resubmission will be based on the totality of data from Outlook Therapeutics’ wet AMD clinical program for ONS-5010, including the NORSE EIGHT trial and other registration clinical trials12.

Regulatory Context:
The company aims to provide an on-label treatment option for wet AMD, replacing off-label use of non-approved formulations of bevacizumab, which have known risks of contamination and inconsistent potency12.

Sources:

1. https://www.drugtopics.com/view/bla-resubmitted-for-investigational-ophthalmic-therapy-from-outlook-therapeutics-inc-

2. https://www.quiverquant.com/news/Outlook+Therapeutics+Announces+Preliminary+Results+from+NORSE+EIGHT+Trial+and+Plans+for+BLA+Resubmission+in+Early+2025

3. https://www.stocktitan.net/news/OTLK/outlook-therapeutics-announces-preliminary-topline-results-of-norse-p72c5eh9tdcg.html

4. https://www.globenewswire.com/news-release/2024/11/27/2988085/0/en/Outlook-Therapeutics-Announces-Preliminary-Topline-Results-of-NORSE-EIGHT-Clinical-Trial.html