Outlook Therapeutics® Re-Submits Biologics License Application for ONS-5010 as a Treatment for Wet AMD to the U.S. Food and Drug Administration

Core Viewpoint - Outlook Therapeutics has re-submitted its Biologics License Application (BLA) for ONS-5010, an investigational ophthalmic product for the treatment of wet age-related macular degeneration (wet AMD), to the FDA, following regulatory approval in the EU and UK for its ophthalmic formulation of bevacizumab [1][8] Group 1: Regulatory Developments - The BLA resubmission is based on the efficacy and safety data from the NORSE EIGHT study and additional chemistry, manufacturing, and controls (CMC) information requested by the FDA [2] - A decision from the FDA regarding the BLA is expected within six months [2] Group 2: Clinical Trial Insights - NORSE EIGHT was a randomized, controlled, parallel-group, masked, non-inferiority study involving 400 newly diagnosed wet AMD subjects [3] - In the NORSE EIGHT study, ONS-5010 showed a mean improvement of 4.2 letters in best corrected visual acuity (BCVA) at week 8, which did not meet the pre-specified non-inferiority endpoint [3] - The 12-week analysis indicated that ONS-5010 demonstrated a mean improvement in BCVA of 3.3 to 5.5 letters, compared to a mean improvement of 4.5 to 6.5 letters in the ranibizumab arm [4] Group 3: Product Information - ONS-5010, branded as LYTENAVA™, is an ophthalmic formulation of bevacizumab for treating wet AMD and has received marketing authorization in the EU and UK [5][8] - In the U.S., ONS-5010 is still investigational and, if approved, would be the first FDA-approved ophthalmic formulation of bevacizumab for retinal indications [8]