Outlook Therapeutics Announces Validation of Marketing Authorization Application by the EMA for ONS-5010 for Wet AMD
Outlook Therapeutics announced the validation of its marketing authorization application (MAA) by the European Medicines Agency (EMA) for ONS-5010 / Lytenava (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (AMD). The formal review process of the MAA by the EMA’s Committee for Medicinal Products for Human Use (CHMP) is now set to begin with an estimated decision date 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,” Russell Trenary, President and CEO of Outlook Therapeutics, said in a company news release. “In addition to the recent acceptance of our BLA by the US FDA and our continued progress toward commercial launch, pending approval, we believe ONS-5010 is well-positioned to provide a preferred treatment option for the retina community and enhance the standard of care in the anti-VEGF space.”
The MAA submission is supported by results from Outlook Therapeutics’ wet AMD clinical program for ONS-5010, which consists of three completed registration clinical trials - NORSE ONE, NORSE TWO and NORSE THREE. If approved, an initial 8 years of regulatory exclusivity in the European Union (EU) is expected for ONS-5010 in wet AMD. The regulatory exclusivity for ONS-5010 could potentially be increased by an additional 2 years if Outlook Therapeutics pursues approvals for additional indications. Outlook Therapeutics is assessing both direct commercialization and partnering in Europe on a country-by-country basis
“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,” added Terry Dagnon, COO of Outlook Therapeutics. “We look forward to working with the EMA and our team of European experts throughout the review process.”