Outlook Therapeutics Inc (NASDAQ:OTLK) announced the validation of the company's Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for an investigational ophthalmic formulation of bevacizumab (ONS-5010) for the treatment of wet age-related macular degeneration (wet AMD).
The formal review process of the application by the EMA’s committee for medicinal products for human use (CHMP) is now set to begin and an estimated decision date is expected in early 2024.
"The validation of our MAA by the EMA is another exciting moment for our team in 2022 and takes us one step closer to offering clinicians and their patients the first and only on-label, ophthalmic bevacizumab to treat wet AMD," said Russell Trenary, the CEO of biopharma firm Outlook Therapeutics.
In addition to the recent acceptance of the company's Biologics License Application (BLA) by the US FDA and its continued progress toward commercial launch, pending approval, he added the firm believed that ONS-5010 was well-positioned to provide a preferred treatment option for the retina community and enhance the standard of care in the anti-vascular endothelial growth factor (VEGF) space.
READ: Outlook Therapeutics encouraged by FDA acceptance of application for drug to treat retinal eye disease wet AMD
The FDA has accepted Outlook Therapeutics’ BLA submission for ONS-5010 to treat wet AMD with a Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023.
Terry Dagnon, the chief operations officer (COO) of Outlook Therapeutics, added: "This is a significant milestone as we continue to execute on our development strategy and position ONS-5010 as a much-needed therapeutic option to treat retinal diseases.
"We are grateful to the team of European experts with whom we closely collaborated to create what we believe is a high-quality dossier for submission that can be used for further regulatory evaluation processes in other regions globally."
Outlook Therapeutics’ wet AMD clinical program for ONS-501 comprised three completed registration clinical trials - NORSE ONE, NORSE TWO and NORSE THREE.
If approved, the company said an initial eight years of regulatory exclusivity in the European Union (EU) was expected for ONS-5010 in wet AMD.
This regulatory exclusivity could potentially be increased by an additional two years if Outlook Therapeutics pursues approvals for additional indications, the company noted.
ONS-5010 is under development as an intravitreal injection for the treatment of wet AMD and other retinal diseases.
Currently, because no approved ophthalmic formulations of bevacizumab are available, clinicians wishing to treat retinal patients with bevacizumab have had to use unapproved repackaged IV bevacizumab provided by compounding pharmacies, products that have known risks of contamination and inconsistent potency and availability.
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