Outlook Therapeutics, Inc. (OTLK), on Friday, announced that it has resubmitted its Biologics License Application to the FDA, seeking approval of ONS-5010 for the treatment of wet age-related macular degeneration or wet AMD.
ONS-5010, an ophthalmic formulation of bevacizumab, received approval in the EU in May 2024 and in the UK in July 2024. It will be marketed under the brand name LYTENAVA starting next quarter.
In the U.S., the FDA declined to approve ONS-5010 in 2023, with the US regulatory agency citing several Chemistry, Manufacturing, and Controls (CMC) issues, unresolved issues from pre-approval manufacturing inspections, and a lack of substantial evidence.
The resubmitted BLA includes data from the NORSE EIGHT clinical trial, a non-inferiority study that compared ONS-5010 to ranibizumab (Lucentis).
The NORSE EIGHT trial results demonstrated clinically meaningful improvements in both anatomical and functional measures, with ONS-5010 showing strong efficacy in improving visual acuity and reducing central retinal thickness, a key indicator of effectiveness in wet AMD.
The FDA is expected to make a decision on the ONS-5010 BLA within six months.
If approved in the U.S., ONS-5010 would become the first FDA-approved ophthalmic formulation of bevacizumab for retinal diseases.
Currently, OTLK is trading at $1.43 up by 5.79 percent on the Nasdaq.
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