The re-submission is based on 3 clinical trials, (NORSE ONE/TWO/THREE) evaluating ONS-5010 vs Lucentis in patients (n=61/228/197) with wet AMD across 9 sites in Australia & 39 in the US along with a P-I clinical trial evaluating the PK of ONS-5010 for the same indication
The results from the (NORSE ONE) trial showed consistent data with the historical data of bevacizumab & the P-III (NORSE TWO) trial showed 41.7% gained ~15 letters of vision as 1EPs, 56.5% gained ≥10 letters as 2EPs & 68.5% gained ≤5 letters
The company also plans to file sBLA for the approval of providing ONS-5010 in a pre-filled syringe, based on the (NORSE SEVEN) trial evaluating the safety of ONS-5010 in a vial vs pre-filled syringe in 120 patients for 3mos.
Ref: Globe Newswire | Image: Outlook Therapeutics
