Trial Profile
A Clinical Effectiveness, Multicenter, Randomized, Double-masked, Controlled Study of the Efficacy and Safety of ONS-5010 in Subjects With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration
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 Choroidal neovascularisation; Wet age-related macular degeneration
- Focus Registrational; Therapeutic Use
- Acronyms NORSE 2; NORSE TWO
- 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.
- 11 Feb 2026 According to an Outlook Therapeutics media release, company announced that it has submitted a Type A meeting request to the U.S. Food and Drug Administration (FDA) following receipt of a Complete Response Letter (CRL) dated December 30, 2025, regarding the Companys Biologics License Application (BLA) for ONS-5010/LYTENAVA (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).
- 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.