ONS-5010 Shows Promise in Treatment of Wet AMD, Reports Lucentis By Investing.com

ISELIN, NJ – Outlook Therapeutics, Inc. (NASDAQ: ), a clinical-stage biopharmaceutical company with a current market capitalization of $52 million, unveiled its investigational drug ONS-5010 at the Hawaii Eye & Retina 2025 meeting. Lucentis in the treatment of wet age-related macular degeneration (wet AMD (NASDAQ: )). According to InvestingPro data, the company’s stock has shown significant price volatility over the past 52 weeks, trading between $0.87 and $12.85. By Dr. Baruch D. The data presented by Cooperman showed early and sustained anatomical improvement and development of better-corrected visual acuity (BCVA).

The NORSE EIGHT clinical trial compared ONS-5010 with ranibizumab, marketed by Lucentis, in patients with wet AMD. Both groups received an intravitreal injection at the beginning of the trial, at week 4, and at the final study visit at week 8, at week 12. The company’s next earnings report on February 13, 2025, investors who follow InvestingPro analysis announced as a price target. It ranges from $3 to $33, indicating considerable 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.

Although it did not meet the non-inferiority endpoint at week 8, the 12-week results indicated that ONS-5010 performed similarly to ranibizumab, with a non-inferiority margin of -1.009 in mean BCVA letter difference. In addition, the treatment resulted in a reduction in central retinal thickness comparable to ranibizumab, with no reported cases of retinal vasculitis in either study arm.

Lawrence Kenyon, chief financial officer and interim CEO of Outlook Therapeutics, expressed optimism about ONS-5010’s potential to treat wet AMD, citing the consistency of safety results in NORSE clinical trials. 5010 plans to reintroduce it in the US.

ONS-5010, also known as LYTENAVA™ (bevacizumab-vikg) in the European Union and the UK, has received marketing authorization in those regions for the treatment of wet AMD. Outlook Therapeutics aims to launch LYTENAVA™ in Europe in the first half of 2025. While InvestingPro’s analysis indicates that the company currently has a poor financial health score, a successful trade deal in Europe could significantly affect its financial outlook. InvestingPro subscribers have access to over 10 key insights into OTLK’s financial health and market conditions.

Like the ophthalmic formulation of bevacizumab, ONS-5010/LYTENAVA™ is designed to inhibit vascular endothelial growth factor (VEGF), which contributes to the development of wet AMD. If approved in the US, bevacizumab would be the first ophthalmic treatment for retinal indications.

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

In other recent news, Outlook Therapeutics has seen a series of significant developments. The company announced the appointment of Russell Trenary as president and CEO, with Lawrence Kenyon as interim CEO. Outlook Therapeutics is 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, the ONS-5010, did not meet the non-inferiority endpoint in the NORSE 8 test. Despite this, Outlook Therapeutics plans to submit a Biologics License Application (BLA) for ONS-5010 in 2025. This decision comes after Chardon Capital Markets upgraded it from buy to neutral following the release of clinical trial results. However, BTIG and HC Wainwright maintained their Buy ratings, revising their price targets to $9.00 and $30.00, respectively.

In addition, the ONS-5010 has received regulatory approval from the European Union and the United Nations Government (TADAWUL:) to treat wet AMD. The company is planning to launch the treatment in Europe in 2025, where it has already been approved. These recent developments are part of Outlook Therapeutics’ ongoing efforts to bring effective treatments to market.

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