OTLK Stock Falls on Failure to Meet Non-Inferiority Goal in AMD Study

Core Viewpoint - Outlook Therapeutics' ONS-5010 (Lytenava) failed to meet the non-inferiority endpoint in the NORSE EIGHT clinical study for treating wet age-related macular degeneration (AMD), leading to a significant drop in share price by 65.2% [2][5] Company Summary - The NORSE EIGHT study involved newly diagnosed wet AMD patients receiving either 1.25 mg ONS-5010 or 0.5 mg Lucentis (ranibizumab) through intravitreal injections, with the primary endpoint being the mean change in best-corrected visual acuity from baseline to week eight [3] - Despite the failure to meet the primary endpoint, ONS-5010 showed vision improvement, biological activity, and a favorable safety profile, with ocular adverse event rates comparable to Lucentis [4] - Further analysis of the study data is ongoing, with full results expected in January 2025, and the company plans to resubmit the biologics license application (BLA) for ONS-5010 in Q1 2025 [5] Regulatory and Market Context - In August 2023, Outlook Therapeutics received a complete response letter (CRL) from the FDA regarding the BLA for ONS-5010, citing concerns related to chemistry, manufacturing, and controls [7][8] - The company has addressed the issues raised by the FDA and received regulatory approval for ONS-5010 in the EU and the U.K. for treating wet AMD, with plans to launch in 2025 [10][11] - ONS-5010 is positioned as a regulated alternative to off-label repackaged Avastin (bevacizumab), which is not approved for ophthalmic use [11]