ISELIN, NJ – Outlook Therapeutics, Inc. (NASDAQ: ), a clinical biopharmaceutical company with a current market cap of $52 million, reported at the Hawaiian Eye and Retina 2025 Meeting that its investigational drug ONS-5010 showed noninferiority to Lucentis in the treatment of wet age-related macular degeneration (wet AMD (NASDAQ:)). According to InvestingPro data, the company’s shares have shown high price volatility, trading between $0.87 and $12.85 over the past 52 weeks. Data presented by dr. Baruch D. Kuppermann, demonstrated early and sustained anatomical improvements and stable gains in best-corrected visual acuity (BCVA).
The NORSE EIGHT clinical trial compared ONS-5010 with ranibizumab, sold under the brand name Lucentis, in patients with wet AMD. Both groups received intravitreal injections at baseline, week 4 and week 8, with the final study visit at week 12. With the company’s next earnings report due on February 13, 2025, investors are following InvestingPro analysis notes that analysts’ price targets range from $3 to $33, suggesting significant upside potential despite current financial challenges. ONS-5010 showed mean BCVA improvements of +3.3, +4.2, and +5.5 letters at months 1, 2, and 3, respectively.
Despite not meeting the non-inferiority endpoint at week 8, the 12-week results suggest that the effect of ONS-5010 is equivalent to ranibizumab, with a difference of -1.009 letters in mean BCVA, within the non-inferiority margin. Additionally, the treatment resulted in a reduction in central retinal thickness comparable to ranibizumab, with no cases of retinal vasculitis reported in either study group.
Outlook Therapeutics’ Chief Financial Officer and Interim Chief Executive Officer, Lawrence Kenyon, expressed optimism about ONS-5010’s potential for the treatment of wet AMD, citing the consistency of safety results across the NORSE clinical trials. The company plans to resubmit a Biologics License Application (BLA) for ONS-5010 in the US in the first quarter of 2025.
ONS-5010, also known as LYTENAVA™ (bevacizumab-vikg) in the EU and the UK, has received marketing approval in those regions for the treatment of wet AMD. Outlook Therapeutics aims to launch LYTENAVA™ in Europe in the first half of 2025. InvestingPro analysis shows that the company currently has a POOR financial health rating, a successful commercialization in Europe could significantly affect its financial prospects. InvestingPro subscribers have access to over 10 additional key insights into OTLK’s financial health and market position.
As an ophthalmic formulation of bevacizumab, ONS-5010/LYTENAVA™ is designed to inhibit vascular endothelial growth factor (VEGF), which contributes to the progression of wet AMD. If approved in the US, it will be the first ophthalmic formulation of bevacizumab for retinal indications.
This report is based on a press release from Outlook Therapeutics.
In other recent news, Outlook Therapeutics has seen a number of notable developments. The company announced the immediate departure of Russell Trenary as president and CEO, with Lawrence Kenyon stepping in as interim CEO. Outlook Therapeutics is also preparing to launch LYTENAVA™, a treatment for wet age-related macular degeneration (AMD) in adults, in the EU and UK in 2025.
The company’s lead product, ONS-5010, failed to meet the non-inferiority endpoint in the NORSE 8 trial. Despite this, Outlook Therapeutics plans to reapply for a biologics license (BLA) for ONS-5010 in 2025. This decision comes after Chardan Capital Markets cut its rating from Buy to Neutral following the release of clinical study results. However, BTIG and HC Wainwright maintained their Buy ratings, adjusting their price targets to $9.00 and $30.00, respectively.
Furthermore, the ONS-5010 has already received regulatory approval in the European Union and the United States Kingdom (TADAWUL:) for the treatment of wet AMD. The company is also preparing to launch in Europe in 2025, where the treatment is already approved. These are the latest developments in Outlook Therapeutics’ ongoing efforts to bring effective treatments to market.
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