Outlook Therapeutics Reports NORSE EIGHT Trial Results for Wet AMD Treatment

Outlook Therapeutics, Inc. has shared preliminary topline results from its NORSE EIGHT clinical trial, the second of two pivotal studies evaluating ONS-5010, an ophthalmic formulation of bevacizumab, for the treatment of wet age-related macular degeneration (wet AMD). While the trial did not meet the non-inferiority endpoint established by the FDA’s special protocol assessment (SPA) at the 8-week mark, the data demonstrated notable improvements in vision and confirmed the drug's biological activity and favourable safety profile. The company is currently analysing the ongoing data, with full three-month efficacy and safety results expected in January 2025, ahead of a planned Biologics License Application (BLA) resubmission in the first quarter of 2025.

The NORSE EIGHT trial assessed visual outcomes by measuring changes in best corrected visual acuity (BCVA) from baseline to week 8. Results showed that patients treated with ONS-5010 experienced an average improvement of +4.2 letters in BCVA, compared to a +6.3 letter improvement in the ranibizumab group. Although the difference in mean BCVA change between the two treatments (-2.257 letters) did not meet the prespecified non-inferiority margin of -3.5, ONS-5010 was well-tolerated, with a safety profile comparable to ranibizumab and no reported cases of retinal vasculitis. These findings are consistent with the safety results seen in previous NORSE studies.

In Europe, where ONS-5010 is marketed under the brand name LYTENAVA™, the therapy has already received marketing approvals from the European Commission and the UK's MHRA. Outlook Therapeutics is preparing for a potential 2025 launch in key markets like the UK and Germany, either independently or through licensing partnerships. The company has also addressed the Chemistry, Manufacturing, and Controls (CMC) issues highlighted in a prior FDA Complete Response Letter (CRL) and continues to collaborate with regulatory authorities to advance ONS-5010 as a viable alternative to off-label repackaged bevacizumab for wet AMD treatment.