Outlook Therapeutics Inc. (NASDAQ: 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.

Also Read: Why Is Eye Disease-Focused Outlook Therapeutics Stock Trading Higher On Friday?

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 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 intends to continue efforts to launch in Europe in 2025, either directly or with a licensing partner.

If approved by the FDA, Outlook Therapeutics 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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