EU validates filing of Lytenava for wet age-related macular degeneration
Outlook Therapeutics announced the validation of its Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for 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 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.
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