Outlook Therapeutics Inc. ( OTLK ) revealed preliminary topline results of NORSE EIGHT, the second of two clinical trials evaluating ONS-5010 in wet AMD patients.

In the NORSE EIGHT trial, ONS-5010 did not meet the pre-specified noninferiority endpoint at week 8 set forth in the special protocol assessment (SPA) with the FDA.

The pre-specified noninferiority endpoint was measured by mean change in best corrected visual acuity (BCVA) from baseline to week 8.

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The difference in the means between the ONS-5010 and Roche Holdings AG’s (OTC:RHHBY) Lucentis (ranibizumab) in the NORSE EIGHT trial was -2.257 BCVA letters, while the lower bound of the pre-specified noninferiority margin in the SPA was -3.5; the hypothesis of noninferiority was not met (p>0.025). 

In the intent-to-treat (ITT) primary dataset, NORSE EIGHT demonstrated a mean +4.2 letter improvement in BCVA in the ONS-5010 arm and +6.3 letter improvement in BCVA in the ranibizumab arm.

However, the preliminary data from the trial demonstrated an improvement in vision and the presence of biologic activity, as well as a continued favorable safety profile for ONS-5010.

Data analysis is ongoing as month 3 data from NORSE EIGHT are being collected. The data is expected to be available in January 2025.

Upon receipt of the full month 3 efficacy and safety results for NORSE EIGHT, Outlook Therapeutics ( OTLK ) plans to resubmit the U.S. marketing application for ONS-5010 in the first quarter of calendar 2025.

ONS-5010/Lytenava (bevacizumab gamma) has already been granted Marketing Authorization in the European Union and the U.K.

Outlook Therapeutics ( OTLK ) intends to continue efforts to launch in Europe in 2025, either directly or with a licensing partner.

If approved by the FDA, Outlook Therapeutics ( OTLK ) plans to commercialize ONS-5010/Lytenava (bevacizumab-vikg) directly in the U.S. It is also assessing partnering options for Lytenava (bevacizumab gamma) in Europe and other regions outside of the U.S.

Price Action: OTLK stock is down 80% at $0.97 during the premarket session at last check Wednesday.

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