Outlook Therapeutics resubmitted its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for ONS-5010, an investigational ophthalmic product, the company said in a press release. If approved, it will be branded as Lytenava (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (nAMD), the company said in a press release. 

The ONS-5010 BLA resubmission is based on the efficacy and safety demonstrated in NORSE EIGHT, as well as additional chemistry, manufacturing, and controls (CMC) information requested by the FDA, the company said. NORSE EIGHT was a randomized, controlled, parallel-group, masked, non-inferiority study of 400 newly diagnosed nAMD subjects, randomized in a 1:1 ratio to receive 1.25 mg ONS-5010 or 0.5 mg ranibizumab intravitreal injections. Subjects received injections at randomization, week 4, and week 8 visits. The primary endpoint was the mean change in best corrected visual acuity (BCVA) from baseline to week 8.

In January 2025, Outlook Therapeutics announced the completed analysis of the 12-week safety and efficacy results for NORSE EIGHT, which indicated that ONS-5010 demonstrated clinically meaningful anatomic and functional improvements at each study timepoint. BCVA data across all study timepoints demonstrated an improvement in vision, increasing over time, and the presence of biologic activity. Results from the 12-week analysis demonstrated a mean improvement in BCVA of 3.3 to 5.5 letters in the ONS-5010 arm across the 4, 8, and 12 week timepoints measured in the study, compared to a mean 4.5 to 6.5 letter improvement in the ranibizumab arm over the same timepoints. Additionally, the NORSE EIGHT data set showed that anatomical response was similar between treatments, with a reduction in central retinal thickness of -123.9 µm for ONS-5010 treated eyes and -127.3 µm for the ranibizumab group. 

A decision from the FDA is expected within 6 months. RP