Outlook Therapeutics Confirms Positive NORSE EIGHT Results for Wet AMD Therapy

Outlook Therapeutics, Inc. (Nasdaq: OTLK) has completed the analysis of its 12-week NORSE EIGHT trial results, confirming the safety and efficacy of ONS-5010 (bevacizumab gamma) for treating wet age-related macular degeneration (wet AMD). The trial demonstrated ONS-5010's noninferiority to ranibizumab, with patients experiencing significant visual acuity improvements of +5.5 letters at week 12. The treatment was well-tolerated, with adverse event rates comparable to ranibizumab and no reported cases of retinal vasculitis. These findings further validate the data from the NORSE TWO pivotal study.

With Marketing Authorization already granted in the EU and UK, Outlook Therapeutics plans to launch ONS-5010 in Europe by mid-2025. The company also aims to resubmit its Biologics License Application (BLA) to the U.S. FDA in Q1 2025. "The NORSE EIGHT results affirm our confidence in ONS-5010 as a safe, effective, and regulated alternative to off-label repackaged bevacizumab for wet AMD," said Lawrence Kenyon, Interim CEO. This marks a significant step toward providing a dedicated treatment option for retinal diseases globally.