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Outlook Therapeutics Reports EMA's Validation of MAA for ONS-5010 to Treat Wet AMD

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Outlook Therapeutics Reports EMA's Validation of MAA for ONS-5010 to Treat Wet AMD

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  • 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

Click here to­ read the full press release 

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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.

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