Outlook Therapeutics presented 12-week data from its NORSE EIGHT clinical trial of ONS-5010 (bevacizumab-vikg) for wet age-related macular degeneration (wet AMD) at the Hawaiian Eye and Retina 2025 Meeting. The results showed ONS-5010 provided early and sustained anatomical improvements comparable to ranibizumab, with steady gains in best corrected visual acuity (BCVA) and a consistent safety profile. The company remains on track for a Biologics License Application (BLA) resubmission in Q1 2025.
These findings are potentially impactful for patients seeking wet AMD treatment. A bevacizumab ophthalmic formulation specifically designed for the eye, like ONS-5010, may offer advantages over currently used, repackaged versions of bevacizumab, potentially streamlining treatment and minimizing risks associated with off-label use. Positive trial results and subsequent FDA approval could broaden treatment access for wet AMD patients.
In the NORSE EIGHT trial, patients receiving ONS-5010 showed mean BCVA improvements of +3.3, +4.2, and +5.5 letters at months one, two, and three, respectively. While the trial did not meet the pre-specified non-inferiority endpoint at week eight, it did meet the non-inferiority margin at month three. Anatomical responses, measured by reduction in central retinal thickness, were comparable between ONS-5010 and ranibizumab. The safety profile of ONS-5010 remained consistent with previous NORSE trials, showing comparable ocular adverse event rates to ranibizumab and no reported cases of retinal vasculitis.
The 12-week NORSE EIGHT results, combined with data from prior NORSE studies, reinforce Outlook Therapeutics’ confidence in ONS-5010’s potential. The anticipated BLA resubmission in Q1 2025 represents a significant step towards potential U.S. approval. This approval could create a new, readily available treatment option for wet AMD, directly impacting the ophthalmology market and offering patients a dedicated ophthalmic formulation of bevacizumab. Moreover, with existing marketing authorization in the EU and UK, Outlook Therapeutics’ plans for a European launch in the first half of 2025 position the company for broader market access and potential revenue generation.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
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FDA Approves LYTENAVA, First Ophthalmic Bevacizumab for Wet AMD
3 weeks ago[…] Bevacizumab has been administered intravitreally in retina clinics for roughly two decades, driving the majority of first-line anti-VEGF treatment in wet AMD, all without a single FDA-approved ophthalmic formulation behind it. That structural anomaly ends now. The FDA has approved LYTENAVA (bevacizumab-vikg) from Outlook Therapeutics as the first FDA-approved ophthalmic formulation of bevacizumab for neovascular age-related macular degeneration, an approval the company projects will carry 12 years of reference product exclusivity under the BPCIA. […]
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