Outlook Therapeutics Reports the US FDA Acceptance of BLA for ONS-5010 to Treat Wet AMD
Shots:
- 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
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
