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Outlook Therapeutics® Announces Validation of Marketing Authorization Application by the European Medicines Agency for ONS-5010 as a Treatment for Wet AMD
Decision for potential approval expected from European Commission in early 2024Submission follows the U.S. FDA acceptance of the ONS-5010 BLA for wet AMD,
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"Decision for potential approval expected from European Commission in early 2024Submission follows the U.S. FDA acceptance of the ONS-5010 BLA for wet AMD, with a PDUFA date of August 29, 2023 ISELIN, N.J., Dec. 22, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today 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 (wet 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,” said Russell Trenary, President and CEO of Outlook Therapeutics. “In addition to the recent acceptance of our BLA by the U.S. 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 eight 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 two 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 collabora...