The US FDA has accepted the BLA for ONS-5010 to treat wet AMD. The US FDA’s decision is expected in Aug 2023 & if ONS-5010 is approved, it will receive 12yrs. of regulatory exclusivity in the US
The (NORSE) program i.e., (NORSE ONE) in 61 patients, P-III (NORSE TWO) in 228 patients & (NORSE THREE) in 197 patients evaluating ONS-5010 vs ranibizumab
The (NORSE TWO) trial met 1EPs & 2EPs, 41.7% gained ≥15 letters of vision; ≥10 letters (56.5%) & ≥5 (68.5%), mean change in BCVA from baseline to 11mos. (11.2 vs 5.8 letters), well-tolerated, and consistent with prior reported data, safety results across the first 3 (NORSE) trials showed a robust benefit-to-risk safety profile. The company also developed registration documents for approvals in the EU with an expected submission in Q4’22
Ref: Outlook Therapeutics | Image: Outlook Therapeutics
