ISELIN, N.J. - Outlook Therapeutics, Inc. (NASDAQ:OTLK), a clinical-stage biopharmaceutical company with a current market capitalization of $52 million, reported at the Hawaiian Eye and Retina 2025 Meeting that its investigational drug ONS-5010 demonstrated non-inferiority to Lucentis in treating wet age-related macular degeneration (wet AMD (NASDAQ:AMD)). According to InvestingPro data, the company's stock has shown high price volatility, trading between $0.87 and $12.85 over the past 52 weeks. The data, presented by Dr. Baruch D. Kuppermann, showed early and sustained anatomic improvements and steady gains in best corrected visual acuity (BCVA).
The NORSE EIGHT clinical trial compared ONS-5010 to ranibizumab, sold under the brand name Lucentis, in patients with wet AMD. Both groups received intravitreal injections at the start of the trial, week 4, and week 8, with a final study visit at week 12. With the company's next earnings report due on February 13, 2025, investors following InvestingPro analysis note that analyst price targets range from $3 to $33, suggesting significant potential upside 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 suggested that ONS-5010's performance was on par with ranibizumab, with a -1.009 letter difference in mean BCVA, within the non-inferiority margin. Additionally, the treatment led to a reduction in central retinal thickness comparable to ranibizumab, with no reported cases of retinal vasculitis in either study arm.
Outlook Therapeutics' Chief Financial Officer and Interim Chief Executive Officer, Lawrence Kenyon, expressed optimism about ONS-5010's potential for treating wet AMD, citing the consistency of safety results across NORSE clinical trials. The company plans to resubmit the Biologics License Application (BLA) for ONS-5010 in the U.S. within the first quarter of 2025.
ONS-5010, also known as LYTENAVA™ (bevacizumab-vikg) in the EU and UK, has received marketing authorization in those regions for wet AMD treatment. Outlook Therapeutics aims to launch LYTENAVA™ in Europe in the first half of 2025. While InvestingPro analysis indicates the company currently maintains a WEAK financial health score, successful commercialization in Europe could significantly impact its financial outlook. InvestingPro subscribers have access to over 10 additional key insights about 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 U.S., it would be the first ophthalmic formulation of bevacizumab for retinal indications.
This report is based on a press release statement from Outlook Therapeutics.
In other recent news, Outlook Therapeutics has seen a series of significant 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, did not meet the non-inferiority endpoint in the NORSE 8 trial. Despite this, Outlook Therapeutics plans to resubmit a Biologics License Application (BLA) for ONS-5010 in 2025. This decision comes after Chardan Capital Markets downgraded its rating from Buy to Neutral following the release of clinical study results. However, BTIG and H.C. Wainwright have maintained their Buy ratings, adjusting their price targets to $9.00 and $30.00 respectively.
Furthermore, ONS-5010 has already received regulatory approval in the European Union and the United Kingdom (TADAWUL:4280) for the treatment of wet AMD. The company is also preparing for a 2025 launch in Europe, where the treatment has already been approved. These are recent developments in Outlook Therapeutics' ongoing efforts to bring effective treatments to market.
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