Trial Profile
Safety and Effectiveness of ONS-5010 Compared to Lucentis® in Subjects With Neovascular Age-related Macular Degeneration; NORSE EIGHT
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 16 Apr 2026
Price :
$35
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At a glance
- Drugs Bevacizumab (Primary) ; Ranibizumab
- Indications Wet age-related macular degeneration
- Focus Registrational; Therapeutic Use
- Acronyms NORSE EIGHT
- Sponsors Outlook Therapeutics
Most Recent Events
- 07 Apr 2026 According to an Outlook Therapeutics media release, based on the data from NORSE TWO and NORSE EIGHT studies the company has submitted a formal dispute resolution request (FDRR) to the U.S FDA as a follow-up to its recent Type A meeting regarding the CRL for the BLA for bevacizumab-vikg. The FDA has accepted the FDRR and has granted a meeting with the deciding official to be conducted in April 2026.
- 06 Mar 2026 According to an Outlook Therapeutics media release, company provided an update following its recent Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the December 30, 2025 Complete Response Letter (CRL) for the Biologics License Application (BLA) for ONS-5010/LYTENAVA, The Company expects to continue engaging in discussions with the FDA to further clarify the Agency's views on confirmatory evidence and the appropriate path forward.
- 03 Nov 2025 According to an Outlook Therapeutics media release, company announced it has re-submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, after receiving the official minutes from the FDA Type A meeting conducted in September 2025.