ONS-5010 Shows Promise in Treating Wet AMD, Comparable to Lucentis By Investing.com



ISELIN, NJ – Outlook Therapeutics, Inc. (NASDAQ:), 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 has demonstrated non-inferiority to Lucentis in the treatment of wet age-related macular degeneration (wet AMD (NASDAQ:)). According to InvestPro According to the data, the company’s shares have 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 lasting anatomical improvements and consistent gains in 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, at weeks 4 and 8, with a final study visit at week 12. With the company’s next earnings report expected on February 13, 2025, the investors who follow InvestPro The analysis notes that analyst price targets range between $3 and $33, suggesting significant upside potential despite current financial challenges. The ONS-5010 showed mean improvements in BCVA of +3.3, +4.2 and +5.5 letters at months 1, 2 and 3 respectively.

Although the non-inferiority criterion was not met at week 8, the 12-week results suggested that the performance of ONS-5010 was comparable to that of ranibizumab, with a difference of -1.009 letters in the Mean BCVA, within the non-inferiority margin. Additionally, the treatment resulted in a reduction in central retinal thickness comparable to that of ranibizumab, with no reported cases of retinal vasculitis in either study group.

Lawrence Kenyon, CFO and interim CEO of Outlook Therapeutics, expressed optimism about the potential of ONS-5010 to treat wet AMD, citing the consistency of safety results in NORSE clinical trials. The company plans to resubmit the Biologics License Application (BLA) for ONS-5010 in the United States in the first quarter of 2025.

ONS-5010, also known as LYTENAVA™ (bevacizumab-vikg) in the EU and UK, has received marketing authorization in these regions for the treatment of wet AMD. Outlook Therapeutics aims to launch LYTENAVA™ in Europe in the first half of 2025. InvestPro The analysis indicates that the company currently maintains a LOW financial health score, a successful commercialization in Europe could have a significant impact on its financial outlook. 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 United States, it would be the first ophthalmic formulation of bevacizumab for retinal indications.

This report is based on a press release from Outlook Therapeutics.

Furthermore, Outlook Therapeutics has undergone a series of important developments. The company announced the immediate departure of Russell Trenary as president and CEO, with Lawrence Kenyon 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 flagship product, ONS-5010, failed to meet the non-inferiority criterion in the NORSE 8 trial. Despite this, Outlook Therapeutics plans to resubmit a biologics license application ( BLA) for ONS-5010 in 2025. The move comes after Chardan Capital Markets lowered its buy rating to neutral following the release of the clinical study results. However, BTIG and HC Wainwright maintained their Buy ratings, adjusting their price targets to $9.00 and $30.00 respectively.

Additionally, the ONS-5010 has already received regulatory approval from the European Union and the United States. Kingdom (TADAWUL:) for the treatment of wet AMD. The company is also preparing 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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