Shots:

• The EMA has validated the MAA for ONS-5010 in wet AMD. The EMA’s decision for review of MAA is expected in early 2024 while ONS-5010 is under development as an IV inj. for wet AMD & other retinal diseases
• The submission was based on 3 trials – (NORSE ONE/TWO/THREE) of ONS-5010 vs ranibizumab in 61/228/197 patients. In the (NORSE ONE), the efficacy & safety data of ONS-5010 were consistent with published studies of bevacizumab in ophthalmology
• The (NORSE TWO) trial met its 1EPs & 2EPs, patients gained 15/≥10/5 letters of vision, 41.7%/56.5%/68.5%, respectively, mean change in BCVA from baseline to 11mos. was 11.2 vs 5.8 letters gained & safety results across the first 3 (NORSE) trials showed a strong benefit-to-risk safety profile. The US FDA has accepted the BLA submission of ONS-5010 with an expected PDUFA date of Aug 29, 2023 

Ref:  Globenewswire | Image: Outlook Therapeutics

Related Posts:- Outlook Therapeutics Reports the US FDA Acceptance of BLA for ONS-5010 to Treat Wet AMD