Trending Topic

23 mins

Trending Topic

Developed by Touch
Mark CompleteCompleted
BookmarkBookmarked
Luke G Qin, Michael T Pierce, Rachel C Robbins

The uvea is a vascular stratum that includes the iris, ciliary body and choroid. Uveitis is defined as inflammation of a part of the uvea or its entirety, but it is also used to describe inflammatory processes of any part of the eye, such as the vitreous or peripheral retina. The clinical taxonomy of uveitis […]

Promising results from the NORSE EIGHT clinical trial on ONS-5010 for wet AMD

touchOPHTHALMOLOGY
Share
Facebook
X (formerly Twitter)
LinkedIn
Via Email
Mark CompleteCompleted
BookmarkBookmarked
Copy LinkLink Copied
Published Online: Jan 27th 2025

Outlook Therapeutics has announced the 12-week efficacy and safety results from the NORSE EIGHT clinical trial evaluating ONS-5010 (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (AMD).1 The findings were presented at the Hawaiian Eye and Retina 2025 Meeting.

The trial was a randomized, controlled, parallel-group, masked, non-inferiority study involving treatment-naïve wet AMD patients. Participants were randomized 1:1 to receive intravitreal injections of either 1.25 mg ONS-5010 or 0.5 mg ranibizumab at baseline, week 4, and week 8, with a final assessment at week 12. Baseline mean best-corrected visual acuity (BCVA) was 58.8 ETDRS letters for the ONS-5010 group and 59.9 letters for the ranibizumab group.

ONS-5010 demonstrated mean BCVA improvements of +3.3, +4.2, and +5.5 letters at months 1, 2, and 3, respectively. The difference in mean BCVA between ONS-5010 and ranibizumab was -1.009 letters (95% confidence interval: -2.865 to 0.848), meeting the non-inferiority margin at month 3 (p=0.0043). Both treatments resulted in similar reductions in central retinal thickness: -123.9 microns for ONS-5010 and -127.3 microns for ranibizumab.

ONS-5010 was generally well-tolerated, with ocular adverse event rates comparable to ranibizumab. No cases of retinal vasculitis were reported in either group. The most common adverse event was conjunctival haemorrhage, occurring in 2.5% of participants in each group.

These results suggest that ONS-5010 provides early and sustained anatomical improvements, with consistent gains in BCVA and a favorable safety profile. ONS-501o was granted Marketing Authorisation in the EU and UK in 2024,2 and plans to resubmit the Biologics License Application (BLA) for ONS-5010 in the first quarter of 2025.

References:

  1. Outlook Therapeutics® Announces Presentation of Efficacy and Safety Results from NORSE EIGHT Clinical Trial Evaluating ONS-5010 for the Treatment of Wet AMD. Outlook Therapeutics. Available at: https://ir.oncobiologics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-presentation-efficacy-and-safety (accessed 27 January 2025).
  2. Outlook Therapeutics® Announces UK MHRA Marketing Authorization of LYTENAVA™ (bevacizumab gamma) for the Treatment of Wet AMD. Outlook Therapeutics. Available at: https://ir.oncobiologics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-uk-mhra-marketing-authorization (accessed 27th January 2025).

Disclosures: This article was created by the touchOPHTHALMOLOGY team utilizing AI as an editorial tool (ChatGPT (GPT-4o) [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.

SIGN UP to touchOPHTHALMOLOGY!

Join our global community today for access to thousands of peer-reviewed articles, expert insights, and learn-on-the-go education across 150+ specialties, plus concise email updates and newsletters so you never miss out.

Click here to REGISTER NOW >>>

Share
Facebook
X (formerly Twitter)
LinkedIn
Via Email
Mark CompleteCompleted
BookmarkBookmarked
Copy LinkLink Copied
Close Popup