Outlook Therapeutics completes analysis of 12-week safety and efficacy results of NORSE EIGHT

Outlook Therapeutics has announced it has completed the analysis of the complete 12-week safety and efficacy results for NORSE EIGHT, evaluating ONS-5010 in wet age-related macular degeneration (AMD) patients. In the trial, ONS-5010 demonstrated noninferiority to ranibizumab at week 12.

According to the company, based on the results from the complete analysis of the 12-week results, it plans to resubmit the Biologics License Application (BLA) for ONS-5010 in the first quarter of 2025.

Julia A. Haller, MD, ophthalmologist-in-chief at Wills Eye Hospital and an Outlook Therapeutics Board member commented on the analysis in a press release from the company.¹

“The 3-month data from NORSE EIGHT provides additional evidence to confirm what retina specialists expected. The clinical trial continues to demonstrate that ONS-5010 injections result in immediate and sustained anatomic efficacy, with steady gains in visual acuity and reliable, consistent safety,” said Haller.

The difference in mean between ONS-5010 and ranibizumab was -1.009 best corrected visual acuity (BCVA) letters with a 95% confidence interval of (-2.865, 0.848) in the NORSE EIGHT trial. ONS-5010 1.25 mg demonstrated a mean change of +5.5 letters in BCVA at week 12 while ranibizumab 0.5 mg demonstrated a mean change of +6.5 letters.¹

In addition to BCVA, mean change in retinal thickness was also reported at week 4, 8, and 12. The mean change in the ONS-5010 1.25 mg arm was -106.6 microns, -117.7 microns, and -123.9 microns respectively. While in the ranibizumab 0.5 mg arm, the mean change in retinal thickness was -108.4 microns, -120.9 microns, and -127.3 microns respectively.¹

As previously announced by the company, ONS-5010 in the NORSE EIGHT trial did not meet the pre-specified non-inferiority endpoint at week 8 set forth in the special protocol assessment (SPA) with the US Food and Drug Administration (FDA). However, the company noted that BCVA data across all time points demonstrated improvement, increasing over time, and the presence of biologic activity.

ONS-5010 was generally well-tolerated with overall ocular adverse event rates comparable to ranibizumab, according to the company. Furthermore, safety results demonstrated across the full duration of NORSE EIGHT were consistent with previously reported safety results from the NORSE ONE, NORSE TWO, and NORSE THREE clinical trials, with no cases of retinal vasculitis reported in either study arm.

Lawrence Kenyon, chief financial officer and interim CEO of Outlook Therapeutic, commented on the results and the potential resubmission to the FDA in a press release.¹

“We believe that the statistically significant 12-week results for ONS-5010 in NORSE EIGHT, combined with the complete NORSE EIGHT data set, confirms our successful NORSE TWO pivotal study and will support the resubmission of our BLA in the United States for the treatment of wet AMD,” said Kenyon. “Our team continues the necessary work for the planned resubmission of our BLA in the first quarter of calendar 2025. We remain confident in the potential of ONS-5010/LYTENAVA to provide an important therapy for the treatment of wet AMD in place of off-label repackaged bevacizumab that has not received regulatory approval for use in retinal diseases here in the United States.”

ONS-5010 was granted marketing authorization in the European Union and United Kingdom in early 2024, and the company states it plans to launch in Europe in the first half of 2025.

References:

1. Outlook Therapeutics® Announces Complete Twelve Week Efficacy and Safety Results of NORSE EIGHT Clinical Trial. Press Release. Published January 16, 2025. Accessed January 16, 2025. https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-complete-twelve-week-efficacy

This post was originally published on this site