Outlook Therapeutics Vision Loss Drug At Par With Novartis Drug

On Thursday, Outlook Therapeutics, Inc. (NASDAQ:OTLK) completed the analysis of the complete 12-week safety and efficacy results for NORSE EIGHT evaluating ONS-5010 in wet age-related macular degeneration (wet AMD) patients.

ONS-5010 demonstrated non-inferiority to Novartis AG (NYSE:NVS) / Roche Holdings AG’s (OTC:RHHBY) Lucentis (ranibizumab) at week 12 in the NORSE EIGHT trial. Based on the completed analysis of the 12-week results, Outlook Therapeutics plans to resubmit the Biologics License Application (BLA) for ONS-5010 in the first quarter of calendar 2025.

The difference in the mean between ONS-5010 and ranibizumab was -1.009 best corrected visual acuity (BCVA) letters.

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

BCVA measures how well a person can see after wearing corrective lenses, such as glasses or contact lenses.

In the intent-to-treat (ITT) population, NORSE EIGHT demonstrated a mean 5.5 letter improvement in BCVA in the ONS-5010 arm and 6.5 letter improvement in BCVA in the ranibizumab arm.

As previously announced, in the NORSE EIGHT trial, ONS-5010 did not meet the pre-specified non-inferiority endpoint at week 8 outlined in the special protocol assessment (SPA) with the U.S. Food and Drug Administration (FDA).

However, BCVA data across all study timepoints demonstrated an improvement in vision, increasing over time, and the presence of biologic activity.

Overall, in NORSE EIGHT, ONS-5010 demonstrated mean visual acuity improvements of +3.3 letters at week 4, +4.2 letters at week 8, and +5.5 letters at week 12.

ONS-5010 was generally well-tolerated with overall ocular adverse event rates comparable to ranibizumab.

ONS-5010/LYTENAVA (bevacizumab gamma) has been approved in the European Union and the United Kingdom. Outlook Therapeutics intends to begin launching in Europe in the first half of calendar 2025.

The company also entered into agreements for warrant inducement transactions expected to result in up to $20.4 million in gross proceeds.

The company will use the proceeds to fund its ONS-5010 clinical development programs, the European commercial launch of LYTENAVA, and working capital and general corporate purposes.

Price Action: OTLK stock is down 9.78% at $2.06 at last check Thursday.

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