Shots:
- The P-III NORSE TWO trial evaluates the safety & efficacy of ONS-5010 / Lytenava vs ranibizumab in 228 patients with wet AMD across 39 clinical trial sites in the US for 12mos.
- The trial met 1EP & 2EPs i.e proportion of patients who gain at least 15 letters in the BCVA & mean change in the BCVA @11mos. In ITT & PP population, patients who gained at least 15 letters (41% vs 23% & 24%) respectively. The safety results were consistent with previously reported safety results of NORSE ONE and NORSE THREE clinical trials
- The company plans to submit a BLA in Q1’22 and will get 12yrs. of marketing exclusivity, if BLA is approved. The company expects to start the study of ONS-5010 for DME and BRVO in late 2021 or early 2022
Click here to to read full press release/ article | Ref: Outlook Therapeutics | Image: Eyewire News
The post Outlook Reports Results of ONS-5010 / Lytenava (bevacizumab-vikg) in P-III NORSE TWO Trial for the Treatment of Wet AMD first appeared on PharmaShots.
